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Journal of the Brazilian College of Surgeons

Official Journal

ENGLISH 6

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November/December

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CONTENTS / SUMÁRIO Rev Col Bras Cir 2017; 44(6)

EDI TO RIAL Multiorganic resections in gastric cancer Ressecções multiorgânicas no câncer gástrico André Maciel da Silva............................................................................................................................................................................. 549

ORI G I NAL ARTIC L ES Corona Mortis: anatomical and surgical description on 60 cadaveric hemipelvises Corona Mortis: descrição anatômica e cirúrgica em 60 hemipelvis cadavéricas Túlio Fabiano de Oliveira Leite; Lucas Alves Sarmento Pires; Kiyoshi Goke; Júlio Guilherme Silva; Carlos Alberto Araujo Chagas ................... 553 Risk factors associated with complications of acute appendicitis Fatores de risco associados às complicações de apendicite aguda Ana Paula Marconi Iamarino; Yara Juliano; Otto Mauro Rosa; Neil Ferreira Novo; Murillo de Lima Favaro; Marcelo Augusto Fontenelle Ribeiro Júnior .................................................................................................................................................................................................... 560 Perioperative synbiotics administration decreases postoperative infections in patients with colorectal cancer: a randomized, double-blind clinical trial A administração perioperatória de simbióticos em pacientes com câncer colorretal reduz a incidência de infecções pós-operatórias: ensaio clinico randomizado duplo-cego Aline Taborda Flesch; Stael T. Tonial; Paulo de Carvalho Contu; Daniel C. Damin ..................................................................................... 567 Brief hospitalization protocol for pressure ulcer surgical treatment: outpatient care and one-stage reconstruction Protocolo de internação breve para tratamento cirúrgico de lesões por pressão: preparo ambulatorial e cobertura em tempo único Dimas André Milcheski; Rogério Rafael da Silva Mendes; Fernando Ramos de Freitas; Guilherme Zaninetti; Araldo Ayres Moneiro Júnior; Rolf Gemperli ............................................................................................................................................................................................... 574 Deaths from abdominal trauma: analysis of 1888 forensic autopsies Óbitos por trauma abdominal: análise de 1888 autopsias médico-legais Polyanna Helena Coelho Bordoni; Daniela Magalhães Moreira dos Santos; Jaísa Santana Teixeira; Leonardo Santos Bordoni ...................... 582 Comparison between isolated serial clinical examination and computed tomography for stab wounds in the anterior abdominal wall Comparação entre exame clínico seriado isolado e tomografia computadorizada nos ferimentos por arma branca na parede anterior do abdome Ricardo Breigeiron; Tiago Cataldo Breitenbach; Lucas Adalberto Geraldi Zanini; Carlos Otavio Corso ................................................................ 596 Intravitreal injection of polysorbate 80: a functional and morphological study Injeção intravítrea de polissorbato 80: estudo funcional e morfológico Francisco Max Damico; Fábio Gasparin; Gabriela Lourençon Ioshimoto; Thais Zamudio Igami; Armando da Silva Cunha Jr.; Silvia Ligorio Fialho; Andre Mauricio Liber; Lucy Hwa-Yue Young; Dora Fix Ventura ........................................................................................ 603 Identification of the sentinel lymph node using hemosiderin in locally advanced breast cancer Identificação do linfonodo sentinela utilizando hemossiderina em casos de câncer de mama localmente avançado Paulo Henrique Walter de Aguiar; Ranniere Gurgel Furtado de Aquino; Mayara Maia Alves; Julio Marcus Sousa Correia; Ayane Layne de Sousa Oliveira; Antônio Brazil Viana Júnior; Luiz Gonzaga Porto Pinheiro ......................................................................... 612 Can renal stone size and the use of the nephrolithometric system increase the efficacy of predicting the risk of failure of percutaneous nephrolithotripsy? O tamanho do cálculo renal e o uso do sistema nefrolitométrico podem aumentar a eficácia de predizer o risco de falha de nefrolitotripsia percutânea? Eduardo Medina Felici; André Luiz Lima Diniz; Tomas Accioly Souza; Luciano Alves Favorito; José Anacleto Dutra Resende Júnior ................ 619 Ruling out intra-abdominal injuries in blunt trauma patients using clinical criteria and abdominal ultrasound Exclusão de lesões intra-abdominais em vítimas de trauma fechado através de variáveis clínicas e ultrassom abdominal completo Flávia Helena Barbosa Moura; José Gustavo Parreira; Thiara Mattos; Giovanna Zucchini Rondini; Cristiano Below; Jacqueline Arantes G. Perlingeiro; Silvia Cristine Soldá; José Cesar Assef ................................................................................................................................... 626

Rev Col Bras Cir

Rio de Janeiro

Vol 44

Nº 6

p 549 / 665

nov/dec

2017


REVI EW AR TIC LES ACERTO guidelines of perioperative nutritional interventions in elective general surgery Diretriz ACERTO de intervenções nutricionais no perioperatório em cirurgia geral eletiva José Eduardo de-Aguilar-Nascimento; Alberto Bicudo Salomão; Dan Linetzky Waitzberg; Diana Borges Dock-Nascimento; Maria Isabel T. D. Correa; Antonio Carlos L. Campos; Paulo Roberto Corsi; Pedro Eder Portari Filho; Cervantes Caporrossi ..................................................... 633 Can reducing the number of stitches compromise the outcome of laparoscopic Burch surgery in the treatment of stress urinary incontinence? Systematic review and meta-analysis A redução do número de pontos pode comprometer o resultado da cirurgia de Burch por via laparoscópica no tratamento da incontinência urinária de esforço? Revisão sistematizada e metanálise Ricardo José Souza; José Anacleto Dutra Resende Júnior; Clarice Guimarães Miglio; Leila Cristina Soares Brollo; Marco Aurélio Pinho Oliveira; Claudio Peixoto Crispi ............................................................................................................................................................................ 649

TECHNI CA L N OTES Tumor lamination in mediastinal giant tumors Laminação tumoral nos tumores gigantes do mediastino Elias Kallas; Rafael Diniz Abrantes; Alexandre Ciappina Hueb ....................................................................................................................... 655 Punch grafts to treat lower limb intractable sores “Punch grafts” nas úlceras de membros inferiores de difícil tratamento Júlio Wilson Fernandes; Rafael Sonoda Akamine; Eduardo Castilho Casagrande .......................................................................................... 659

ERRATUM Erratum Errata ................................................................................................................................................................................................................ 665

Rev Col Bras Cir

Rio de Janeiro

Vol 44

Nº 6

p 549 / 665

nov/dec

2017


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16 a 19 de maio de 2018 Expo Unimed Curitiba / PR

14º Congresso Brasileiro de Videocirurgia 3º Congresso Brasileiro e Latinoamericano de Cirurgia Robótica

Principais temas « O futuro é agora – Como a tecnologia está mudando a

cirurgia « Hérnia inguinal e qualidade de vida: o que os cirurgiões

devem saber! estamos perdendo a cabeça? « Cirurgia bariátrica revisional « A melhor opção cirúrgica para o T2DM não controlado é ...

INTERNACIONAIS CONVIDADOS

« A cirurgia metabólica diminui a mortalidade?

Agustin Alvarez (CHI)

« Resultados da pancreactectomia MIS

Arnold P. Advincula (USA)

« Esofagectomia robótica: alguma vantagem?

Eduardo Moreno Paquetin (MEX)

« Reganho de peso: papel do endoscopista

Eduardo Parra-Davila (USA)

« Como eu manejo minhas complicações (sessão de vídeos)

Gustavo Stringel (USA)

« Coloproctologia - anastomose laparoscópica

intra-corpórea: existem vantagens? « Evolução histórica do tratamento do câncer do reto:

abandonando o bisturi? « Endometriose profunda com acometimento intestinal « Anatomia retroperitoneal aplicada à cirurgia laparoscópica « Derivações urinárias intracorpóreas: quais os desafios?

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« Imagens 3D no planejamento da nefrectomia parcial 95

Haris Khwaja (UK) Horácio Asbun (USA) Jacques Marescaux (FRA) Jean Michael Fabre (FRA) Lee Swanstrom (FRA) Maurice Chung (USA) Michael Rosen (USA) Phillip Shadduck (USA) Salvador Morales-Conde (ESP) Silvana Peretta (FRA)

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América Latina

Sociedade Brasileira de Cirurgia Bariátrica e Metabólica

Organização e Viagens

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www.sobracil.org.br/congresso

« Cirurgia robótica e parede abdominal: é o futuro ou


Órgão Oficial do Colégio Brasileiro de Cirurgiões EDITOR

ASSOCIATE EDITORS

Guilherme Pinto Bravo Neto TCBC-RJ Associate Professor, Department of Surgery, Faculdade de Medicina, Universidade Federal do Rio de Janeiro-UFRJ-Rio de Janeiro-RJ-Brasil.

FELIPE CARVALHO VICTER TCBC - RJ - UNIVERSIDADE DO ESTADO DO RIO DE JANEIRO - UERJ – RIO DE JANEIRO – RJ, BRASIL RODRIGO MARTINEZ TCBC-RJ - UNIVERSIDADE FEDERAL DO RIO DE JANEIRO – UFRJ - RIO DE JANEIRO – RJ – BRASIL FERNANDO PONCE DE LEON ACBC- RJ – UNIVERSIDADE FEDERAL DO RIO DE JANEIRO – UFRJ – RIO DE JANEIRO – RJ-BRASIL

LIBRARIAN

Lenita Penido Xavier

WRITING ASSISTANT David S. Ferreira Júnior

GRAPHIC DESIGN HG Design Digital Ltda.

RESPONSIBLE JOURNALIST João Maurício Carneiro Rodrigues

ADVISORY BOARD ABRÃO RAPOPORT - ECBC-SP - Hospital Heliópolis - São Paulo - SP - BR ALDO DA CUNHA MEDEIROS - ECBC-RN - Universidade Federal do Rio Grande do Norte – Natal – RN - BR ALEXANDRE FERREIRA OLIVEIRA - TCBC-PE - Universidade Federal de Pernambuco – Recife – PE - BR ÁLVARO ANTONIO BANDEIRA FERRAZ - TCBC-PE - Universidade Federal de Pernambuco – Recife – PE - BR ANA CRISTINA GOUVEIA MAGALHÃES - Universidade Federal do Rio de Janeiro- Rio de Janeiro- RJ – BR ANDY PETROIANU - TCBC-MG – Universidade Federal de Minas Gerais – Belo Horizonte – MG - BR ANTONIO CARLOS VALEZI - TCBC-PR – Universidade Estadual de Londrina - Londrina - PR – BR ANTONIO JOSÉ GONÇALVES - TCBC-SP – Faculdade de Ciências Médicas da Santa Casa de São Paulo- São Paulo - SP - BR ARLINDO MONTEIRO DE CARVALHO JR. - TCBC-PB - Universidade Federal da Paraíba João Pessoa - PB - BR CARLOS ALBERTO PORCHAT - TCBC-RJ - Hospital Clementino Fraga Filho da Universidade Federal do Rio de Janeiro - RJ - BR CARLOS ANSELMO LIMA - TCBC-SE- Universidade Federal de Sergipe – Aracaju - SE - BR CARLOS DELROY - Universidade Federal de São Paulo - São Paulo - SP - BR DAYSE COUTINHO VALENTE - TCBC-RJ- Instituto Fernando Luiz Barroso – Rio de Janeiro - RJ - BR DIOGO FRANCO - TCBC-RJ - Universidade Federal do Rio de Janeiro- Rio de Janeiro – RJ - BR DJALMA JOSE FAGUNDES - ECBC-SP - Universidade Federal de São Paulo – São Paulo – SP – BR EDMUND CHADA BARACAT - TCBC – SP - Universidade Federal de São Paulo – São Paulo – SP – BR EDNA FRASSON DE SOUZA MONTERO - TCBC-SP- Universidade Federal de São Paulo – São Paulo – SP – BR EDUARDO CREMA - TCBC-MG - Universidade Federal do Triângulo Mineiro - Uberaba MG - BR EDUARDO HARUO SAITO - TCBC-RJ- Universidade do Estado do Rio de Janeiro – Rio de Janeiro - RJ - BR ELIZABETH GOMES DOS SANTOS - TCBC-RJ - Universidade Federal do Rio de Janeiro – Rio de Janeiro – RJ - BR FÁTIMA CARNEIRO FERNANDES - Universidade Federal do Rio de Janeiro - Rio de Janeiro - RJ - BR FLÁVIO DANIEL SAAVEDRA TOMASICH - TCBC-PR – Hospital de Clínicas da Universidade Federal do Paraná – Curitiba –PR- BR FLÁVIO MALCHER M. DE OLIVEIRA - TCBC-RJ - Hospital Universitário Gaffrée e Guinle - Rio de Janeiro - RJ - BR FREDERICO AVELLAR SILVEIRA LUCAS - TCBC-RJ - Instituto Nacional do Câncer – Rio de Janeiro - RJ - BR GIULIANO ANCELMO BENTO - ACBC- RJ – Universidade do Estado do Rio de Janeiro – Rio de Janeiro – RJ – BR GUSTAVO PEREIRA FRAGA - TCBC-SP - Universidade Estadual de Campinas – Campinas - SP – BR HAMILTON PETRY DE SOUZA - ECBC-RS - Pontifícia Universidade Católica do Rio Grande do Sul – Porto Alegre - RS – BR HAROLDO VIEIRA DE MORAES Jr. - Universidade Federal do Rio de Janeiro - Rio de Janeiro - RJ - BR HENRI CHAPLIN RIVOIRE - TCBC-RS -Universidade Federal do Rio Grande do Sul - Porto Alegre - RS - BR HENRIQUE MURAD - ECBC-RJ - Universidade Federal do Rio de Janeiro - Rio de Janeiro - RJ - BR JOSÉ ANACLETO DUTRA RESENDE Jr. - Hospital Universitário Pedro Ernesto-UERJ - Rio de Janeiro - RJ - BR JOSÉ EDUARDO DE AGUILAR NASCIMENTO - TCBC-MT-Universidade Federal de Mato Grosso – Cuiabá – MT –BR JOSÉ EDUARDO FERREIRA MANSO - TCBC-RJ – Universidade Federal do Rio de Janeiro – Rio de Janeiro – RJ – BR JOSÉ LUIZ BRAGA DE AQUINO - TCBC-SP - Faculdade de Ciências Médicas - PUC Campinas - SP - BR JOSÉ MARCUS RASO EULÁLIO - TCBC-RJ – Universidade Federal do Rio de Janeiro – Rio de Janeiro – RJ – BR JOSÉ MAURO DA SILVA RODRIGUES - TCBC-SP - Pontifícia Universidade Católica de São

Paulo - São Paulo - SP - BRA JOSÉ WILSON NOLETO - Universidade Federal da Paraíba - João Pessoa - PB - BR JULIO CESAR BEITLER - TCBC-RJ – Universidade Estácio de Sá – Rio de Janeiro - RJ - BR JÚLIO CEZAR UILI COELHO - TCBC-PR – Universidade Federal do Paraná – Curitiba - PR – BR KATIA SHEYLA MALTA PURIM - Universidade Positivo - Curitiba - PR - BR LEONEL DOS SANTOS PEREIRA - Universidade Federal do Rio de Janeiro - Rio de Janeiro - RJ - BR LISIEUX EYER DE JESUS - TCBC-RJ- Universidade Federal Fluminense – Niterói – RJ – BR LUIZ CARLOS DUARTE DE MIRANDA - ACBC-RJ - Universidade Federal do Rio de Janeiro - Rio de Janeiro - RJ - BR LUIZ CARLOS VON BAHTEN - TCBC-PR- Universidade Federal do Paraná – Curitiba - PR – BR LUIZ GUSTAVO DE OLIVEIRA E SILVA - TCBC-RJ- Hospital Federal de Ipanema/Ministério da Saúde- Rio de Janeiro - RJ - BR LUIZ RONALDO ALBERTI - Universidade Federal de Minas Gerais – Belo Horizonte – MG –BR MANOEL XIMENES NETO - ECBC-DF –Universidade de Brasília – Brasília - DF - BR MANUEL DOMINGOS DA CRUZ GONÇALVES - ECBC-RJ- Universidade Federal do Rio de Janeiro- Rio de Janeiro –RJ – BR MARCOS ALPOIN FREIRE - TCBC-RJ- Universidade Federal do Rio de Janeiro- Rio de Janeiro – RJ – BR MARIA APARECIDA DE ALBUQUERQUE CAVALCANTE - Universidade Federal do Rio de Janeiro - Rio de Janeiro - RJ - BR MARIA DE LOURDES P. BIONDO SIMÕES - TCBC-PR – Pontifícia Universidade Católica do Paraná – Curitiba – PR - BR MARCELO AUGUSTO F. RIBEIRO JR. - TCBC-SP - Universidade de Santo Amaro- UNISA - São Paulo - SP - BR MAURÍCIO AUGUSTO S. MAGALHÃES COSTA - TCBC-RJ - Sociedade Brasileira de Mastologia - Rio de Janeiro - RJ - BR MAURO ANTÔNIO C. GUIMARÃES FILHO - Hospital Moinho dos Ventos - Porto Alegre - RS- BR MAURO DE SOUZA LEITE PINHO - TCBC-SC – Universidade da Região de Joinville – Joinville - SC - BR NELSON ADAMI ANDREOLLO - TCBC-SP – Universidade Estadual de Campinas Campinas - SP - BR NELSON ALFRED SMITH - Universidade Federal do Rio de Janeiro- Rio de Janeiro – RJ – BR NELSON FONTANA MARGARIDO – TCBC-SP – Universidade de São Paulo – São Paulo – SP – BR ORLANDO JORGE MARTINS TORRES - TCBC-MA - Universidade Federal do Maranhão - São Luís - MA - BR OSVALDO MALAFAIA - ECBC-PR- Universidade Federal do Paraná – Curitiba –PR- BR PAULO FRANCISCO GUERREIRO CARDOSO - ACBC-RS- Fundação Faculdade Federal de Ciências Médicas de Porto Alegre – Porto Alegre – RS - BR PAULO GONÇALVES DE OLIVEIRA - TCBC-DF - Universidade de Brasília – Brasília - DF - BR RENATO ABRANTES LUNA - TCBC-RJ - Hospital Federal dos Servidores do Estado do Rio de Janeiro - Rio de Janeiro - RJ - BR RICARDO ANTONIO CORREIA LIMA - TCBC-RJ – Universidade Federal do Estado do Rio de Janeiro- Rio de Janeiro – RJ – BR RICARDO VITOR COHEN - TCBC-SP - Hospital Alemão Oswaldo Cruz - São Paulo - SP - BR ROBERTO CAMPOS MEIRELLES - TCBC-RJ - Universidade do Estado do Rio de Janeiro - Rio de Janeiro - RJ - BR RODRIGO ALTENFELDER SILVA - TCBC-SP - Faculdade de Ciências Médicas da Santa Casa de São Paulo - São Paulo - SP-BR RODRIGO FELIPPE RAMOS - TCBC - RJ - Universidade Federal Fluminense - Niterói - RJ - BR ROGERIO APARECIDO DEDIVITIS - TCBC-SP - Universidade de São Paulo - São Paulo SP - BR RUFFO DE FREITAS JÚNIOR - TCBC-GO - Universidade Federal de Goiás - Goiânia – GO – BR SILVIA CRISTINE SOLDÁ - TCBC-SP- Faculdade de Ciências Médicas da Santa Casa de São Paulo- São Paulo - SP - BR SILVIO HENRIQUES DA CUNHA NETO – TCBC- RJ - Universidade Federal do Rio de Janeiro- Rio de Janeiro – RJ – BR SIZENANDO VIEIRA STARLING - TCBC-MG - Hospital João XXIII - Belo Horizonte - MG - BR THALES PAULO BATISTA - TCBC-PE- Faculdade Pernambucana de Saúde/ Instituto de Medicina Integral Professor Fernando Figueira - Recife - PE - BR VIVIAN RESENDE - TCBC-MG - Universidade Federal de Minas Gerais - Belo Horizonte MG - BR WILSON CINTRA JR. - TCBC-SP-Universidade de São Paulo- São Paulo- SP - BR


NATIONAL CONSULTANTS ALCINO LÁZARO DA SILVA, ECBC-MG - Universidade Federal de Minas Gerais - MG ALUIZIO SOARES DE SOUZA RODRIGUES, ECBC-RJ - Universidade Federal do Rio de Janeiro - UFRJ - RJ ANTONIO PELOSI DE MOURA LEITE, ECBC-SP - Instituto de Moléstias Cardiovasculares de São José do Rio Preto - SP DARIO BIROLINI, ECBC-SP - Faculdade de Medicina da Universidade de São Paulo - SP EUGÊNIO AMÉRICO BUENO FERREIRA, ECBC-SP - Faculdade de Medicina de Jundiaí - SP FERNANDO LUIZ BARROSO, ECBC-RJ - Hospital Municipal de Ipanema - RJ. FERNANDO MANOEL PAES LEME, ECBC-RJ - Faculdade de Medicina de Campos - RJ GASPAR DE JESUS LOPES FILHO, TCBC-SP - Universidade Federal de São Paulo - SP GUILHERME EURICO BASTOS DA CUNHA, ECBC-RJ - Universidade Federal Fluminense - RJ HELÁDIO FEITOSA DE CASTRO FILHO, TCBC-CE Universidade Federal do Ceará - CE ISAC JORGE FILHO, TCBC-SP - Universidade de Ribeirão Preto - SP. JOSÉ REINAN RAMOS, TCBC-RJ - Hospital Vitória-RJ LUIZ GUILHERME BARROSO ROMANO, ECBC-RJ MARCOS F. MORAES, ECBC-RJ - Universidade Gama Filho-RJ

ORLANDO MARQUES VIEIRA, ECBC-RJ - Universidade Federal do Rio de Janeiro-RJ ROBERTO SAAD JR., TCBC-SP - Faculdade de Ciências Médicas da Santa Casa de São Paulo-SP SAMIR RASSLAN, ECBC-SP - Faculdade de Medicina da Universidade de São Paulo-SP SAUL GOLDENBERG, ECBC-SP - Universidade Federal de São Paulo- Escola Paulista de Medicina - SP

INTERNATIONAL CONSULTANTS ARNULF THIEDE - Department of Surgery, University of Würzburg Hospital, Oberdürrbacher Str. 6, D-97080 Würzburg, Germany CLAUDE DESCHAMPS - M.D - The Mayo Clinic, MN,USA EDUARDO PARRA-DAVILA - Florida Hospital Celebration Health - 400 Celebration Pl, Kissimmee, FL 34747, USA. EMILIO DE VICENTE LÓPEZ – Sanchinarro Hospital, Madrid, Spain KARL H. FUCHS - Markus-Krankenhaus Frankfurter Diakonie-Kliniken, Wilhelm- Epstein-Straße 4, 60435 Frankfurt am Main MURRAY BRENNAN - HeCBC Department of Surgery, Memorial SloanKettering Cancer Center, New York NY, USA ULRICH ANDREAS DIETZ - Department of Surgery I, University of Würzburg, Medical School, Würzburg, Germany W. WEDER - Klinikdirektor-UniversitätsSpital Zürich, Switzerland

FORMER EDITORS 1967 - 1969 JÚLIO SANDERSON

1969 - 1971 JOSÉ HILÁRIO

1973 - 1979 HUMBERTO BARRETO

1980 - 1982 EVANDRO FREIRE

1980 - 1982 EVANDRO FREIRE

1983 - 1985 JOSÉ LUIZ XAVIER PACHECO

1986 - 1991 MARCOS MORAES

1992 - 1999 MERISA GARRIDO

2000 - 2002 2002 - 2005 JOSÉ ANTÔNIO GOMES DE SOUZA GUILHERME PINTO BRAVO NETO

2006 - 2015 JOSÉ EDUARDO FERREIRA MANSO

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GRAPHIC DESIGN – COVER Libertta Comunicação JOURNAL OF THE BRAZILIAN COLLEGE OF SURGEONS

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contato@sbcbm.org.br


Editorial

DOI: 10.1590/0100-69912017006012

Multiorganic resections in gastric cancer Ressecções multiorgânicas no câncer gástrico

ANDRÉ MACIEL DA SILVA, TCBC-RJ1.

G

astric cancer is the fifth most common malignant tumor in the world, surpassed only by malignant neoplasms of the lung, breast, colon/rectum and prostate. About 70% of cases occur in developing countries. It is the third leading cause of cancer death in both genders, behind lung and liver neoplasms1. There are expected 12,920 new cases of stomach cancer in men and 7600 in women in Brazil, in the year 2016. Excluding non-melanoma skin tumors, it is the fifth most incident cancer in the country2.

Helicobacter pylori infection, consumption of salt and smoked foods, obesity, high alcohol consumption and smoking are the main risk factors for the disease. Unfortunately, most cases of gastric cancer are unveiled in advanced stages, notably in the West and in developing countries. Japan and South Korea are exceptions, where efficient screening programs have enabled a higher percentage of diagnosis in an early stage. According to the eighth TNM classification for malignant tumors of the International Union for Cancer Control (UICC), gastric cancer that invades adjacent structures (liver, colon, small intestine, adrenal, diaphragm, pancreas, spleen, kidney) is classified as pT4b. These tumors present a major challenge, since they are usually associated with an important decrease in the patient’s general condition and, not infrequently, in peritoneal (microscopic or even macroscopic) dissemination. The diagnosis of pT4b gastric tumors is not an easy task. The clinical-pathological correlation is very flawed: it is not uncommon that we interpret a computed tomography scan as an invasion of adjacent organ (cT4b) and then confirm a desmoplastic reaction in the

anatomopathological specimen analysis. In a meta-analysis published in 2011, Seevaratnam et al.3 studied the role of computed tomography in determining T4 status in gastric cancer: the accuracy of the radiological method was 80%. In another systematic review, Cardoso et al.4 showed that the accuracy of endoscopic ultrasonography in evaluating T4 gastric tumors (79%) is very similar to that of computed tomography. Even the intraoperative evaluation is flawed, which eventually leads the surgeon to a multiorganic resection when in fact the structure adjacent to the tumor did not present a real invasion, but rather a desmoplastic reaction. Some Japanese series5,6 show that, in up to 55% of cases, what was treated as tumor invasion at laparotomy was, in fact, a desmoplastic reaction confirmed by the pathologist. In particular, the challenge of evaluating tumor invasion is even greater when we deal with a tumor closely related to the pancreas. Piso et al.7 found pancreatic invasion in only 39% of patients submitted to gastrectomy associated with monobloc pancreatectomy. Peritoneal dissemination can be assessed by staging laparoscopy. Some studies show that laparoscopy promoted a change in the therapeutic strategy in 20 to 50% of the cases, sparing many patients from an unnecessary laparotomy8-10. In a retrospective study involving 65 patients submitted to radical surgery, Carboni et al.11 reached R0 surgery in 40 patients (61.5%). Of these, 80% presented invasion of adjacent organs/structures at the anatomopathological evaluation (pT4b). In the remaining 25 patients the procedure was not radical: in 18 patients the surgical margins were microscopically affected (R1 sur-

1 - Head, General Surgery Service, Federal Hospital of Andaraí MS/RJ; Oncologic Surgeon, Service of Abdominal-Pelvic Surgery, National Cancer Institute, Rio de Janeiro, RJ, Brazil. Rev Col Bras Cir 2017; 44(6): 549-552


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gery) and in the other seven the surgery was R2 (margin macroscopically affected by tumor). On the other hand, Xiao et al.12 reached R0 surgery in 68.2% of the cases of their retrospective series of 63 patients. In only 39.7% of the patients, tumor invasion of the adjacent organ was confirmed by the anatomopathological analysis. Considering the aggressiveness of the multiorganic surgery, arises the discussion of the real benefit of this procedure when compared to palliative resections or even to the derivative procedures. Kim et al.13 evaluated 132 patients undergoing surgery for T4 gastric cancer. They compared three subgroups: multiorgan surgery (group 1), isolated gastrectomy (group 2) and surgery without resection, such as gastrojejunostomy and intraperitoneal chemotherapy (group 3). Group 3 included a considerably larger number of patients with Borrmann IV tumor, peritoneal dissemination and distant metastasis. In the multivariate analysis, surgical radicality (R0 vs R1 vs R2) had an impact on survival despite the important disparity between the groups. When groups 1 and 2 were compared, survival at five years was greater in group 1, with statistical significance. In a retrospective series of 169 patients submitted to multiorganic resection, Oñate-Ocaña et al.14 also found different survival rates when compared patients who underwent R0 surgery with those submitted to R1/R2 surgery. Several studies have sought to evaluate survival after multivisceral resection in gastric cancer according to the associated resected organ. Cheng et al.15 demonstrated a higher median survival in patients with hepatic invasion when compared with invasion of the pancreas, colon and spleen. Min et al.16 evaluated 243 pT4b patients who underwent R0 surgery. Five-year overall survival was 36.8% and median survival was 26 months. In patients with pancreatic invasion, survival at five years was 23.3%, whereas in patients without pancreatic invasion, survival at five years was 42.1%. In patients with pancreatic invasion, there was no survival at five years when resection involved duodenopancreatectomy. In patients who received another type of pancreatic resection (distal pancreatectomy and wedge resection), five-year survival was 27.4%. Due to the high morbidity of multivisceral surgery and the high mortality found in some series, several authors tried to stratify the main prognostic factors

in the surgical treatment of pT4b patients. An important multicenter Italian study17 evaluated 112 cT4b patients undergoing multivisceral resection. In 98 patients (87.5%) there was invasion of adjacent organs (pT4b). They obtained R0 surgery in 43 patients (38.4%), R1 in 30 (26.8%), and R2 in 39 (34.5%). They also assessed nodal status: 12 patients N0, 34 N1, 33 N2 and 33 N3. After surgery, patients received adjuvant chemotherapy. There was no homogeneity in the adjuvant protocols, the ECF scheme (epirubicin, cisplatin and fluorouracil) being the most used. As a result, adjuvant chemotherapy was not considered in the statistical analysis. Survival at one, three and five years was 60.7%, 30.3% and 27.2%, respectively. The multivariate analysis showed that the resection status (R0 vs. R1 vs R2) and the nodal status (N0 vs N1 vs N2 vs N3) are the main prognostic factors in multivisceral resection. The five-year survival was 43.7% in the R0 surgery and 31.4% in the R1 resection. There was no 5-year survival in patients undergoing R2 surgery. For patients pN0, pN1, pN2 and pN3, the survival was 53.3%, 40.4%, 26.5% and 0%, respectively. When comparing N0 and N+ patients, there was a significant impact on survival in five years (pN0=53.3% vs pN+=21.5%, p=0.006). In a systematic review of the literature, which included 17 studies of 1,343 patients, Brar et al.18 also found the resection status and the nodal status as the main prognostic factors in multiorgan resection for advanced gastric cancer. The authors also ponder the morbimortality of multivisceral resection and the difficulty in defining the invasion of adjacent organs before indicating the extended pocedure. More recent studies have attempted to stratify patients so as to achieve maximum benefit with multiorgan resection. Min et al.16 exclude from the multivisceral resection patients with lymph node metastasis in the para-aortic chain and those who would require associated duodenopancreatectomy. There are also trends in the literature19 that suggest neoadjuvant treatment, either with chemotherapy or with chemotherapy + radiotherapy, in order to promote tumors’ downstaging and to evaluate the biological response – in case of disease progression, patients would be spared from extensive surgery without therapeutic benefit. Neoadjuvant therapies (chemotherapy/radiotherapy) and/or adjuvants (chemotherapy/radiotherapy) when associated with multiorga-

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nic resection in locally advanced gastric cancer, could also contribute to better cancer outcomes, notably with increased survival. We lack prospective and randomized studies aimed at patients with T4b tumors to better define the role of (neo) adjuvant therapies. Hyperthermochemotherapy, associated with multivisceral surgery, is another alternative due to the high probability of microscopic peritoneal spread in T4b tumors. The curative treatment of patients with pT4b gastric cancer requires an experienced multidisciplinary team, as it will involve the surgical-anesthetic team, intensivists, clinical oncologist and even the radiotherapist (the latter two in the scenario of neoadjuvance/adjuvance). Preferably, patients should be referred to referral centers trained and experienced in the treatment of gastric cancer. In practice, most patients will be submitted to palliative treatment, be it surgical, clinical or even palliative care. Considering the literature published so far on the subject of gastric cancer and multivisceral resection, we can conclude that: - Gastric cancer is a global public health problem. - Except for countries like Japan and South Korea, where there are effective programs to track gastric cancer, the disease is most often diagnosed in advanced stages. - pT4b gastric tumors represent a challenge for

the therapeutic team and, especially, for the surgical one. - The correct staging of pT4b tumors is still limited by current radiological methods. - Even during the surgical procedure, the distinction between desmoplastic reaction and actual invasion of the adjacent organ still poses a challenge. - Surgery is the central pillar of gastric cancer treatment. In tumors pT4b, multiorganic resection represents the radical surgical treatment with curative intent. - The pT4b tumors with invasion of the head of the pancreas seem to have a worse prognosis when compared to the invasion of other structures adjacent to the stomach. - A judicious selection of patients is of paramount importance to achieve low morbimortality in multivisceral resection for gastric cancer. - R0 surgery and the absence of lymph node metastasis (and possibly N1 status) are the main prognostic factors in multiorgan surgery for gastric cancer. - Neoadjuvant therapies may contribute to the selection of patients who are candidates for multiorganic resection. Neoadjuvant and/or adjuvant therapies may improve oncologic outcomes when associated with multiorganic resection in gastric cancer. - The literature aimed at patients with T4b gastric tumors consists essentially of retrospective studies. It would be very important to develop prospective, randomized studies to define the optimal therapeutic protocol for such patients.

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Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015;136(5):E35986. Brasil. Ministério da Saúde. Instituto Nacional de Câncer José Alencar Gomes da Silva. Estimativa 2016: incidência de câncer no Brasil. Rio de Janeiro: INCa; 2015. Seevaratman R, Cardoso R, McGregor C, Lourenço L, Mahar A, Sutradhar R, et al. How useful is preoperative imaging for tumor, node, metastasis

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(TNM) staging for gastric cancer? A meta-analysis. Gastric Cancer. 2012;15 Suppl 1:S3-18. Cardoso R, Coburn N, Seevaratman R, Sutradhar R, Lourenço LG, Mahar A, et al. A Systematic review and meta-analysis of the utility EUS for preoperative staging for gastric cancer. Gastric Cancer. 2012;15 Suppl 1:S19-26. Kitamura K, Tani N, Koike H, Nishida S, Ichikawa D, Taniguchi H, et al. Combined resection of the involved organs in T4 gastric cancer. Hepatogastroenterology. 2000;47(36):1769-72. Isozaki H, Tanaka N, Tanigawa N, Okajima K. Prognostic factors in patients with advanced gastric cancer with macroscopic invasion to adjacent

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organs treated by radical surgery. Gastric Cancer. 2000;3(4):202-10. Piso P, Bellin T, Aselmann H, Bektas H, Schlitt HJ, Klempnauer J. Results of combined gastrectomy and pancreatic resection in patients with advanced primary gastric carcinoma. Dig Surg. 2002;19(4):281-5. Yano M, Tsujinaka T, Shiozaki H, Inoue M, Sekimoto M, Doki Y, et al. Appraisal of treatment strategy by staging laparoscopy in locally advanced gastric cancer. World J Surg. 2000;24(9):1130-5; discussion 1135-6. Lehnert T, Rudek B, Kienle P, Buhl K, Herfarth C. Impact of diagnostic laparoscopy on the management of gastric cancer: prospective study of 120 consecutive patients with primary gastric carcinoma. Br J Surg. 2002;8(4):471-5. Blackshaw GR, Barry JD, Edwards P, Allison MC, Thomas GV, Lewis WG. Laparoscopy significantly improves the perceived preoperative stage of gastric cancer. Gastric Cancer. 2003;6(4):225-9. Carboni F, Lepiane P, Santoro R, Lorusso R, Mancini P, Sperduti I, et al. Extended multiorgan resection for T4 gastric carcinoma: 25-year experience. J Surg Oncol. 2005;90(1):95-100. Xiao L, Li M, Xu F, Ye H, Wu W, Long S, et al. Extended multi-organ resection for cT4 gastric carcinoma: a retrospective analysis. Pak J Med Sci. 2013;29(2):581-5. Kim JH, Jang YJ, Park SS, Park SH, Kim SJ, Mok YJ,

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et al. Surgical outcomes and prognostic factors for T4 gastric cancers. Asian J Surg. 2009;32(4):198204. Oñate-Ocaña LF, Becker M, Carrillo JF, AielloCrocifoglio V, Gallardo-Rincón D, Brom-Valladares R, et al. Selection of best candidates for multiorgan resection among patients with T4 gastric carcinoma. J Surg Oncol. 2008;98(5):336-42. Cheng TC, Tsai CY, Hsu JT, Vinayak R, Liu KH, Yeh CN, et al. Aggressive surgical approach for patients with T4 gastric carcinoma: promise or myth? Ann Surg Oncol. 2011;18(6):1606-14. Min JS, Jin SH, Park S Kim SB, Bang HY, Lee JI. Prognosis of curatively resected pT4b gastric cancer with respect to invaded organ type. Ann Surg Oncol. 2012;19(2):494-501. Pacelli F, Cusumano G, Rosa F, Marrelli D, Dicosmo M, Cipollari C, Marchet A, Scaringi S, Rausei S, di Leo A, Roviello F, de Manzoni G, Nitti D, Tonelli F, Doglietto GB; Italian Research Group for Gastric Cancer. Multivisceral resection for locally advanced gastric cancer: an Italian multicenter observational study. JAMA Surg. 2013;148(4):353-60. Brar SS, Seevaratnam R, Cardoso R, Yohanathan L, Law C, Helyer L, et al. Multivisceral resection for gastric cancer: a systematic review. Gastric Cancer. 2012;15 Suppl 1:S100-7. Hawkins WG. The case for neoadjuvant therapy in locally advanced gastric cancer. JAMA Surg. 2013:148(4):361.

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Original Article

DOI: 10.1590/0100-69912017006001

Corona Mortis: anatomical and surgical description on 60 cadaveric hemipelvises Corona Mortis: descrição anatômica e cirúrgica em 60 hemipelvis cadavéricas TÚLIO FABIANO DE OLIVEIRA LEITE1; LUCAS ALVES SARMENTO PIRES2; KIYOSHI GOKE3; JÚLIO GUILHERME SILVA4; CARLOS ALBERTO ARAUJO CHAGAS2. A B S T R A C T Objective: to report the prevalence of arterial corona mortis and to describe its surgical and clinical applicabilities. Methods: We dissected 60 hemipelvises (50 men and 10 women) fixed in a 10% formalin solution for the purpose of gathering information on corona mortis. We measured the caliber and length of the obturator artery and its anastomotic branch with the aid of a digital caliper and submitted the data to statistical analyzes and comparisons with the GraphPad Prism 6 software. Results: arterial corona mortis was present in 45% of the studied sample. The most common origin of the obturator artery was the internal iliac artery; however, there was one exceptional case in which it originated from the femoral artery. The caliber of the anastomotic branch was on average 2.7mm, whereas the caliber of the obturator artery was 2.6mm. Conclusion: the vascular connections between the obturator, internal iliac, external iliac and inferior epigastric arterial systems are relatively common over the upper pubic branch. The diameter and a trajectory of the anastomotic artery may vary. Thus, iatrogenic lesions and pelvic and acetabular fractures can result in severe bleeding that puts the patient’s life at risk. Keywords: Corona Mortis. Anatomic Variation. Anatomy. General Surgery.

INTRODUCTION

T

he obturator artery (OA) has a very variable origin, usually originating from the anterior wall of the internal iliac artery (IIA). It runs anteriorly and inferiorly on the pelvic wall below the obturator nerve (ON), perforating the obturator fascia and reaching the obturator foramen (OF)1-3. In its trajectory the OA distributes several collateral branches: two muscular branches (for the iliac and internal obturator muscles), a pubic branch (which runs on the posterior surface of the pubis body to anastomose with the ipsilateral branch), a bladder branch (to the posterior face of the urinary bladder) and an anastomotic branch1,2. This latter deserves special attention due to its trajectory, as it crosses the upper branch of the pubis (UBP) perpendicularly and anastomoses with the inferior epigastric artery (IEA)1,2. After exiting the pelvis, the OA is divided into two terminal branches, an internal branch, with path at the inner border of the OF giving branches to the external obturator, pectin, and gracile muscles, and an external branch, which runs at

the OF outer border to form the cruciform anastomosis1. The IEA, on the other hand, is a branch of the external iliac artery (IEA). Stemming a few millimeters above the inguinal ligament (LI), it runs horizontally and superiorly to the transverse fascia and runs anteriorly towards the arcuate line, between the rectus abdominis muscle and a posterior layer of its sheath. The IEA then anastomoses with an upper epigastric artery, a branch of the internal thoracic artery. During its trajectory, the IEA gives a branch to the spermatic cord, a suprapubic branch and an anastomotic branch (for the OA)1,2,4. Corona mortis (CM), or death crown, is defined as an arterial or venous connection between the anastomotic branches of the obturator artery and the inferior epigastric artery over the superior branch of the pubis5-9. This anatomical variant is of clinical and surgical interest, as it is susceptible to iatrogenic lesions during hernia repairs, gynecological and orthopedic procedures, and may also be damaged in fractures of the pubis or acetabulum. The literature also reports the

1 - Medical School, University of São Paulo, Institute of Radiology, São Paulo, SP, Brazil. 2 - Fluminense Federal University, Department of Morphology, Niterói, RJ, Brazil. 3 - Estácio de Sá University, Department of Anatomy, Rio de Janeiro, RJ, Brazil. 4 - Federal University of Rio de Janeiro, Department of Physiotherapy, Rio de Janeiro, RJ, Brazil. Rev Col Bras Cir 2017; 44(6): 553-559


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difficulty in performing CM hemostasis and the fact that this anatomical variation determines collateral circulation between EIA and the IIA5-10. This work aims to address the surgical and anatomical aspects of this arterial connection in 60 cadaveric hemipelvis.

METHODS We dissected 60 hemipelvises of adult corpses (50 men and 10 women) fixed in 10% formalin solution to analyze the vascular pattern of the pelvic region, specifically the origins and anastomoses of the OA. Among the pelvis dissected, 32 were left and 28, right. The cadavers used in this study belonged to the Anatomy Laboratory of the Gama Filho University. After the dissection and analysis of the OA origin, we measured its trajectory (form origin to OF) and its caliber (transverse diameter) with the aid of a digital caliper. If the anastomotic branch of OA was present, we also evaluated this vesselâ&#x20AC;&#x2122;s length, caliber and distance from the upper branch of the pubis to the pubic symphysis. We performed the statistical analysis with the GraphPad Prism 6 software. We report morphometric data as mean Âą standard deviation (SD). We compared the length and caliber of the anastomotic branch of both genders and sides using the Mann-Whitney-U test, considering a p-value <0.05 as significant). This work followed the norms of the 1995 Helsinki Declaration (revised in Edinburgh, 2000).

Figure 1. Dissection of a right hemipelvis. Anterior view. The Corona Mortis can be seen above the upper branch of the pubis.

External iliac artery (EIA), external iliac vein (EIV), venous Corona Mortis (vCM), arterial Coronal Mortis (aCM), upper pubic branch (UPB), obturator nerve (ON), obturator artery (OA), obturator vein (OV).

Figure 2. Dissection of a left hemipelvis. Anterior view. The common trunk between the inferior epigastric artery and the obturator artery can be seen. External iliac artery (EIA), external iliac vein (EIV), common trunk between obturator and inferior epigastric arteries (CT), inferior epigastric artery (IEA), upper pubic branch (UPB), obturator artery (OA).

RESULTS The most common origin for OA was the IIA (45%) (Figure 1), followed by a common trunk with IEA from the EIA (36.68%) (Figure 2). There was one case where the OA originated from the femoral artery (1.66%). The percentage of all origins can be verified in table 1. Of the 60 hemipelvises, 27 (45%) had arterial CM: 21 were men (77.77%) and six were women (22.23%) (Table 2). The Mann-Whitney U test did not reveal a statistically significant difference of the length and caliber of the anastomotic branch between genders or sides (p>0.05).

Table 1. Origins of the obturator artery.

Origin

Number of Cases

%

Internal Iliac Artery

27

45%

Common trunk with the Inferior Epigastric Artery

22

36.38%

Superior Gluteal Artery

6

10%

Inferior Epigastric Artery

4

6.66%

Femoral Artery

1

1.66%

Total

60

100%

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Table 2. Prevalence of arterial Corona Mortis (CM).

Arterial CM Absent

Men

Women

Total

21 (77.77%)

6 (22.23%)

27 (45%)

-

-

33 (55%)

The mean OA caliber was 2.56±0.5mm. The mean OA length was 57±15mm. The anastomotic branch had a total length of 45±4.6mm, a mean caliber of 2.66±0.5mm and distance between the UBP and the pubic symphysis was on average 49.62±4.68mm. We summarize these results in table 3.

Table 3. Morphometric data of the obturator artery and its anastomotic branch.

Anastomotic branch (n = 60)

Obturator artery

Caliber

2.66 ± 0.5

2.567 ± 0.5

Length

45 ± 4.6

57.00 ± 15

Distance (UPB x pubic symphysis)

(n = 60)

49.62 ± 4.68

Results are described as mean ± standard deviation. UPB = upper pubic branch.

DISCUSSION Vascular formation during the embryonic period consists of the appearance of vessels and anastomoses that may or may not persist during ontogenesis10. Two arterial plexuses are formed through the dorsal root of the umbilical artery: the abdominal plexus and the pelvic plexus. During the fifth week of development, the umbilical arteries form a new connection to the fifth pair of lumbar segmental arteries (which form the pelvic plexus), and then form the IIA, the EIA, and consequently the common iliac artery. The OA is formed through the IIA, whereas all other arteries of the lower limbs develop like branches from the EIA, for example, the IEA10-12. Due to the large number of anastomoses during this period, such arteries are susceptible to originate from neighboring vessels. Therefore, a random selection of arterial canals would explain the variability of the OA origin13. This

555

selection would also imply differences in the caliber of the OA and the IEA, causing the variation known as CM. Anatomical variations of the OA origin are described in detail in the literature: it may originate from the EIA, from an ischial-pudendal trunk (formed by the internal pudendal and lower gluteal arteries), the upper or lower gluteal arteries, the internal pudendal artery, the femoral artery and from two distinct roots (one from the EIA and another from the IIA)1-3,10,11. The OA can also originate from the IEA, ilium-lumbar artery, lower bladder artery, vaginal artery, accessory hemorrhoidal artery, external pudendal artery, accessory pudendal artery, prostatic artery, and internal pudendal artery1,14. The IEA, on the other hand, has a varied origin in relation to its position, as it can originate as much as 6cm above the inguinal ligament1-3. This vessel may originate in the femoral artery and ascend to the pelvis through the femoral ring, from the deep femoral artery, from a common trunk with the deep circumflex artery of the ilium or from the OA itself and, in addition, there was a described case where the IEA originated from two distinct roots (from the EIA and IIA)1,2. Unusual branches of the IEA may be the dorsal artery of the penis (or clitoris), the superficial epigastric artery, the deep circumflex artery of the ilium, the medial femoral circumflex artery, and the accessory external pudendal artery. The suprapubic and funicular branches may be absent1,3. According to Testut and Latarjet1, when the OA branches from the EIA, it can reach the OF through two distinct trajectories: 1) it can descend vertically through the lateral wall of the femoral vein or 2) it can enter the OF obliquely and inferiorly when crossing the superior wall of the femoral vein. The authors report that the second possibility is dangerous during hernia surgeries, due to its proximity to the hernial sac3. Goss2 states that the most dangerous moment of this second trajectory is when the OA crosses the lacunar ligament. Our results showed that the OA originated along with the IEA (or from it) in 36.68% of the cases, a significant percentage. In one of the hemipelvises studied, the OA originated from the femoral artery: a fact reported only once in a study by Sañudo et al.11. Although the anatomy books describe the usual presence of the anastomosis between the OA and IEA anastomotic branches, they do not use the term Corona

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Mortis, and few books cite its clinical and surgical importance. The term consists of two Latin words: “corona” (used in anatomy to design structures in the form of a crown or circular form), and “mortis”, which comes from the term “mors”, meaning death4,15. It definition is intriguing because some authors believe that it is any form of anastomosis between the IEA and the OA or between the IIA and the EIA6,8,9,16,17, while others believe that CM is only the anastomosis of the OA and IEA anastomotic branches5. Authors like Gilroy et al.16, Mahato18 and Jusoh et al.13 use terms such as “aberrant”, “accessory” or “anomalous” to refer to CM. Gilroy16 states that the prevalence of CM is high, and therefore should not be called by such terms. We share this opinion. The prevalence of arterial CM (with or without venous CM) has been reported in numerous studies, ranging from 12 to 65%5,6,8,9,16-26. The results of other studies are summarized in table 4. These numbers should draw the attention of surgeons and anatomists because the number of studies reporting a prevalence greater than 20% is higher, indicating that this variation in the arterial form is not so unusual. Tabela 4. Prevalence of corona mortis (CM) according to the literature.

Author/Year Tornetta et al. (1996)19 Teague et al. (1996)20 Gilroy et al. (1997)16 Karakurt et al. (2002)5 Lau and Lee (2003)21 Okcu et al. (2004)6 Hong et al. (2004)22 Darmanis et al. (2007)8 Mahato (2009)18 Rusu et al. (2012)23 Stavropoulou-Deli and Anagnostopoulou (2013)24 Pellegrino et al. (2014)9 Ates et al. (2015)17 Tajra et al. (2016)25 Talalwah (2016)26 Present study

Total hemipelvises

Prevalence of arterial CM

50 78 105 98 142 150 50 80 50 40

34% 43% 38% 28.5% 22% 19% 34% 36% 22% 65%

20

40%

50 391 22 208 60

31% 28.4% 13.69% 12% 45%

Reports of the arterial CM’s length vary: 62mm according to Tornetta et al.19, 52mm according to Hong et al.22, 68mm according to Darmanis et al.8 and 52.4mm according to Stavropoulou-Deli and Anagnostopoulou24. The CM’s caliber is has on average between 2.6mm8,22 and 3mm24. The present study revealed similar results, the length being 49.6±4.6mm, and the caliber, 2.6±0.5mm. The caliber should alarm surgeons and clinicians as this vessel can cause significant bleeding should it rupture. The IEA and OA are susceptible to iatrogenic lesions during procedures due to their variable nature7,15,27,28, as seen previously. The CM may be injured during laparoscopic approaches for repair of inguinal and femoral hernias, preperitoneal or extraperitoneal repair at the moment of attachment of the mesh to the pectineum ligament (Cooper’s), which may lead to uncontrollable bleeding, pseudoaneurysms and formation of retroperitoneal hematomas29,30. Traditional (Stoppa) accesses used for fractures of the anterior pelvic region and the anterior acetabular column are related to a high risk of hemorrhage and additional damage to adjacent structures, such as soft tissues and neurovascular structures27. The difficulty in repairing these fractures is in identifying a safe place to position the implant, especially in just-articular and quadrilateral fractures27. In pubic osteotomies, procedures with relatively high complication rates, the CM can be injured due to a limitation of the surgical field. Since the presence of CM on the UBP posed a potential risk of injury in orthopedic surgeries, some authors suggest preoperative imaging to identify possible vascular anatomical variation to minimize complications31. Ates et al.17 evaluated the risk of vascular injury in CM during extraperitoneal repairs and concluded that to prevent this complication careful dissection is necessary on the posterior face of UBP and to apply clips or hemostatic clamps on the pectine ligament near the pubic symphysis. Although UBP fractures are treated with analgesics and rest, they can result in hypovolemic shock with death risk due to CM rupture. Signs of vascular injury are: palpable and painful mass in the lower abdomen, hypoperfusion, and difficulty in urinating caused

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by compression of the urinary tract by a pelvic hematoma32. An apparently benign UBP fracture associated with thermodynamics instability should raise suspicion of CM rupture, especially in elderly and anticoagulated patients. Avulsion of CM can be identified by an angiotomography4,15. Alternative treatments, such as CM embolization, may be used to stop bleeding7. Burch’s colposuspension, introduced in 1961, was the gold standard for the treatment of stress urinary incontinence. Recently, this procedure has fallen into disuse due to the emergence of new minimally invasive techniques, such as the retropubic sling (introduced in 1998) or the transobturator sling (2002). These new methods, though minimally invasive, are not free of complications, since CM can still be injured24,33. Prostatic artery embolization has shown promising results for the treatment of benign prostatic hyperplasia. The study of these vessels’ anatomy should be necessary, since the prostatic artery may be an OA branch. Thus, understanding the arterial anatomy is essential for the interventional radiologist to perform the procedure safely and adequately14.

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One of the interesting aspects of CM is the ability to function as a collateral circulation path10. In a case described by Khandari et al.34, CM played a key role after the patient underwent avascular acetabular necrosis due to an inadequate treatment of a transverse fracture. In this situation the arterial CM participated as a collateral circulation to supply the lower limb, avoiding amputation. This aspect of CM, though extremely important, is of little emphasis in the literature. We observed that the vascular connections between the obturator, internal and external iliac and inferior epigastric systems are relatively common over the UBP. The diameter and trajectory of this anastomotic artery may vary. Iatrogenic lesions and pelvic and acetabular fractures can result in severe bleeding that puts the patient’s life at risk. On the other hand, this anastomosis has a considerable role as a pathway of collateral circulation in peripheral arterial obstructive disease. Thus, we note the importance of studying this anatomical variation, since we do not consider it as unusual as previously thought.

R E S U M O Objetivo: relatar a prevalência da corona mortis arterial e descrever suas aplicabilidades cirúrgicas e clínicas. Métodos: sessenta hemipelvises (50 homens e 10 mulheres) fixadas em uma solução de formalina a 10% foram dissecadas com o propósito de obter informações sobre a corona mortis. Medidas do calibre e comprimento da artéria obturatória e seu ramo anastomótico foram mensuradas com o auxílio de um paquímetro digital e submetidas a análises e comparações estatísticas no programa GraphPad Prism 6. Resultados: a corona mortis arterial esteve presente em 45% da amostra estudada. A origem mais comum da artéria obturatória foi da artéria ilíaca interna, porém, houve um caso excepcional no qual a artéria obturatória se originou da artéria femoral. O calibre do ramo anastomótico foi em média 2.7mm, enquanto que o calibre da artéria obturatória foi 2.6mm. Conclusão: as conexões vasculares entre os sistemas obturatório, ilíacos interno e externo e epigástrico inferior são relativamente comuns sobre o ramo superior da pube. O diâmetro e a trajetória dessa artéria anastomótica podem variar. Assim, lesões iatrogênicas, fraturas pélvicas e acetabulares podem resultar em hemorragias graves que colocam a vida do paciente em risco. Descritores: Corona Mortis. Variação Anatômica. Anatomia. Cirurgia Geral.

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Testut L, Latarjet A. Tratado de anatomía humana. Barcelona: Salvat; 1958. Goss CM, editor. Gray’s anatomy of the human body. Philadelphia: Lea & Febiger; 1973. Bergman R, Thompson S, Afifi A, Saadeh F. Compendium of human anatomic variation: text,

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atlas, and world literature. Baltimore: Urban & Schwarzenberg; 1988. Garrido-Goméz J, Pena-Rodríguez C, MartínNoguerol T, Hernández-Cortes P. Corona mortis artery avulsion due to a stable pubic ramus fracture. Orthopedics. 2012;35(1):e80-2. Karakurt L, Karaca I, Yilmaz E, Burma O, Serin E. Corona mortis: incidence and location. Arch Orthop

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Trauma Surg. 2002;122(3):163-4. Okcu G, Erkan S, Yercan HS, Ozic U. The incidence and location of corona mortis: a study on 75 cadavers. Acta Orthop Scand. 2004;75(1):53-5. Lorenz JM, Leef JA. Embolization of postsurgical obturator artery pseudoaneurysm. Semin Intervent Radiol. 2007;24(1):68-71. Darmanis S, Lewis A, Mansoor A, Bircher M. Corona mortis: an anatomical study with clinical implications in approaches to the pelvis and acetabulum. Clin Anat. 2007;20(4):433-9. Pellegrino A, Damiani GR, Marco S, Ciro S, Cofelice V, Rosati F. Corona mortis exposition during laparoscopic procedure for gynecological malignancies. Updates Surg. 2014;66(1):65-8. Goke K, Pires LAS, Tulio TFO, Chagas CAA. Rare origin of the obturator artery from the external iliac artery with two obturator veins. J Vasc Bras. 2016;15(3):250-3. Sañudo J, Mirapeix R, Rodriguez-Niedenführ M, Maranillo E, Parkin IG, Vázquez T. Obturator artery revisited. Int Urogynecol J. 2011;22(10):1313-8. Schoenwolf GC, Bleyl SB, Brauer PR, Francis-West PH. Larsen’s human embryology. 5th ed: Churchill Livingstone; 2014. Jusoh AR, Rahman NA, Latiff AA, Othman F, Das S, Ghafar NA, et al. The anomalous origin and branches of the obturator artery with its clinical implications. Rom J Morphol Embryol 2010;51(1):163-6. Garcia-Monaco R, Garategui L, Kizilevsky N, Peralta O, Rodriguez P, Palacios-Jaraquemada J. Human cadaveric specimen study of the prostatic arterial anatomy: implications for arterial embolization. J Vasc Interv Radiol. 2014;25(2):315-22. Kong WM, Sun CK, Tsai IT. Delayed presentation of hypovolemic shock after a simple pubic ramus fracture. Am J Emerg Med. 2012;30(9):e2091-4. Gilroy AM, Hermey DC, DiBenedetto LM, Marks SC Jr, Page DW, Lei QF. Variability of the obturator vessels. Clin Anat 1997;10(5):328-32. Ates M, Kinaci E, Kose E, Soyer V, Sarici B, Cuglan S, et al. Corona mortis: in vivo anatomical knowledge and the risk of injury in totally extraperitoneal inguinal hernia repair. Hernia. 2016;20(5):659-65. Mahato NK. Retro-pubic vascular anomalies: a

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Leite Corona Mortis: anatomical and surgical description on 60 cadaveric hemipelvises

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Received in: 05/04/2017 Accepted for publication: 20/07/2017 Conflict of interest: none. Source of funding: none. Mailing address: TĂşlio Fabiano de Oliveira Leite E-mail: tuliofabiano@hotmail.com / lucaspires@id.uff.br

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Original Article

DOI: 10.1590/0100-69912017006002

Risk factors associated with complications of acute appendicitis Fatores de risco associados às complicações de apendicite aguda

ANA PAULA MARCONI IAMARINO1; YARA JULIANO1; OTTO MAURO ROSA1; NEIL FERREIRA NOVO1; MURILLO DE LIMA FAVARO1; MARCELO AUGUSTO FONTENELLE RIBEIRO JÚNIOR, TCBC-SP1. A B S T R A C T Objective: to identify the main risk factors associated with the development of complications in patients with acute appendicitis. Methods: we conducted a case-control study of 402 patients with acute appendicitis hospitalized in a secondary hospital, divided into two groups: the control group, with 373 patients who progressed without postoperative complications (Group 1) and the study group, with 29 patients who presented complications (Group 2). We evaluated demographic data, signs and symptoms of the disease, imaging tests and hospitalization data. Results: factors associated with complications were fever, radiological and sonographic changes, abrupt positive decompression and diarrhea. Migration of pain, nausea, vomiting and abrupt positive decompression were the findings that were significantly more frequent in both groups (p = 0.05). The duration of signs and symptoms in days in group 2 was significantly higher than in group 1, with a median of three days for the group with complications (p = 0.05). Conclusion: alterations in imaging, fever, diarrhea, positive abrupt decompression, duration of symptoms and lower age are associated with a higher frequency of complications in acute appendicitis, which reinforces the importance of anamnesis, physical examination and indication of complementary exams in the approach of these patients. Keywords: Appendicitis. Appendectomy. Intraoperative Complications. Diagnosis.

INTRODUCTION

T

he acute inflammatory abdomen encompasses the major conditions seen by surgeons working in emergency services around the world. It is a clinical picture ranging from simple, self-limiting, benign diagnoses to those that threaten life and require rapid surgical intervention. About 6.5% of emergency room visits are due to abdominal pain1. Acute appendicitis (AA) represents the most common surgical condition in the abdomen. It presents an incidence of 48.1 per 10,000 inhabitants per year, and its peak incidence occurs in patients between ten and 20 years of age. The overall lifetime risk is estimated between 5% and 20%, being 8.6% for men and 6.7% for women2,3. It affects approximately 250,000 patients per year in the United States and is responsible for at least 40,000 hospital admissions per year in England1. The signs and symptoms are usually anorexia, periumbilical colic, nausea and vomiting, followed by moderate fever (38° C) and signs of peritoneal inflammation in the lower right quadrant of the abdomen4,5. Many of these

findings, however, may occur in other clinical or surgical conditions, such as mesenteric lymphadenitis, intraperitoneal hemorrhage, acute salpingitis, endometriosis, Meckel’s diverticulitis, among others. Diagnosis is made based on clinical evaluation and confirmed by leukocyte counting, ultrasonography (US) and radiographic studies of the abdomen2,6. Incorrect diagnosis is more frequent in children, in women, and in the elderly6. The accuracy of a good anamnesis, combined with a well-performed physical examination, is 95% in patients who present a classic clinical picture7. The complications resulting from the evolution of the acute inflammatory process, such as suppuration, perforation with or without hemorrhage, and gangrene of the appendix are serious, making early surgery fundamental to contain the evolution of the condition5. The treatment of acute appendicitis is appendectomy, conventional or laparoscopic. However, antibiotic therapy alone, with drugs against Gram negative and anaerobic bacteria, has been used, since it has the potential to considerably reduce the costs associated with surgery8,9. Studies suggest that non-surgical the-

1 - Santo Amaro University and Grajaú General Hospital, General Surgery, São Paulo, SP, Brazil. Rev Col Bras Cir 2017; 44(6): 560-566


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rapy is safe, provided that the patient has an adequate follow-up and can undergo operative treatment if necessary8. But despite the technological progress in diagnosis and therapy, acute appendicitis continues to be an important cause of morbidity and mortality, especially in the extremes of age, in which signs and symptoms may not have a classic clinical presentation. This study aims to evaluate the main risk factors associated with the development of complications in patients with acute appendicitis.

METHODS We conducted a case-control study by means of data analysis of the medical records of hospitalized patients diagnosed with acute appendicitis in the year 2013 at the Grajaú General Hospital (HGG - Instituto de Responsabilidade Sírio Libanês) and at the Santo Amaro University. We obtained data from the Inpatient Management System and included all patients with acute appendicitis in this period, regardless of age. Patients with suspected acute appendicitis were submitted to clinical and laboratory evaluation according to the institutional protocol of abdominal pain. In the presence of clinical findings suggestive of appendicitis, imaging examinations (abdominal radiographs, ultrasonography and/or computed tomography) followed. With the diagnosis established, the surgery was performed through an incision in the right iliac fossa. We evaluated demographic data, signs and symptoms, imaging and hospitalization data, as well as the following postoperative complications: intra-abdominal abscess, sepsis and wound infections. We used the Cochran G, Chi-square, Fisher’s exact, Mann-Whitney, and Kendall concordance tests in the statistical analysis10. The present work was submitted to and approved by the Ethics in Research Committee of the Santo Amaro University, under the opinion of number 624735.

RESULTS We studied 402 patients, divided into two groups: control group (Group 1), with patients who

presented no postoperative complications (n=373), and study group (Group 2), composed of patients presenting with complications (n=29). Of the 373 patients in group 1, 220 (59%) were male and 153 (41%) were female. The pediatric population (up to 12 years of age) corresponded to 31%, or 116 patients. In group 2, 15 (52%) were male and 14 (48%) female. The pediatric population were 19 patients (65%). In group 2 the postoperative complications observed were: intra-abdominal abscess in 19 cases (65%), wound infections in seven (24%), and sepsis in six (21%), and three patients had two simultaneous complications. Drainage of the peritoneal cavity was performed in 62% of patients in group 2. Computed Tomography (CT) was not performed in 21 patients (72%) of group 2 and in 256 patients (68%) of group 1, because the diagnosis had been confirmed by other methods. The mean age of group 1 was 21.9 years (1 to 65 years) and the mean length of hospital stay was 3.05 days. In group 2, the mean age was 16.9 years (2 to 45 years) and the mean length of hospital stay was 13.1 days. Regarding the evolutionary phases of appendicitis, according to the surgical description, group 1 had 55 (15%) patients in the edematous stage, 140 (38%) in the phlegmonous phase, 99 (26%) in the gangrenous phase, 75 (20%) in perforated phase and four (1%) patients had normal appendices (tactical appendectomy). Group 2 had three (10%) patients in the edematous phase, five (17%) in the phlegmonous phase, eight (28%) in the gangrenous phase and 13 (45%) in the perforated phase. From the Cochran G test, the factor frequencies for the two groups were compared and the following factors were associated with appendicitis: pain migration, nausea and vomiting, and painful decompression (PD+) were significantly (p=0.05) in both groups (Table 1). For the comparison between the control and the study groups, we used the chi-square test or the Fisher’s exact test (Table 2). There were significant differences between the groups for the following factors: anorexia (group 1 > group 2), fever (2>1), alteration in radiological exams

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(2>1) and alteration in Ultrasound (2>1). PD+ and diarrhea suggested differences between groups (2>1 for

both). The other factors did not present significant differences between groups.

Table 1. Comparison of the findings between the groups with and without complications.

Patients No Complication

Main Findings

Complication

n

Frequency

n

Frequency

Migration of pain

359

96%

27

93%

Nausea and vomiting

274

73%

24

83%

PD+

300

80%

27

93%

Fever (> 37.3)

163

44%

21

72%

X-ray Change

71

19%

13

45%

US Change

87

23%

12

41%

CT Change

76

20%

8

27%

Anorexia

96

26%

2

0,07%

Diarrhea

47

13%

7

24%

G Test

G = 1166.32 (p=0.0000)

G = 91.20 (p=0.0000)

PD+: sudden painful decompression; US: ultrasound; CT: computed tomography. Table 2. Comparison of frequencies of the factors associated with appendicitis between the two groups.

Variable Migration of pain Anorexia Nausea/vomiting PD+ Fever (> 37.3) Diarrhea X-ray Change US Change CT Change

Group

Present

Absent

1

359 (96.2%)

14

2

27 (93.1%)

2

1

96 (25.7%)

277

2

2 (6.6%)

27

1

274 (73.5%)

99

2

24 (82.8%)

5

1

246 (66%)

127

2

23 (79.3%)

6

1

163 (43.7%)

210

2

21 (72.4%)

8

1

47 (12.6%)

326

2

7 (24.1%)

22

1

71 (19%)

302

2

13 (44.8%)

16

1

87 (23.3%)

286

2

12 (41.4%)

17

1

76 (20.4%)

297

8 (27.6%)

21

p 0.3234 0.0132 * 0.1910 0.0996 ** 0.0025 * 0.0771 ** 0.0023 * 0.0572 * 0.3576

* findings that reached statistical significance; ** findings strongly suggestive of positivity; PD+: sudden painful decompression; US: ultrasound; CT: computed tomography. Rev Col Bras Cir 2017; 44(6): 560-566


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We ordered the frequencies of the associated factors in descending order and applied the Kendall test to analyze the concordance between groups, according to table

3, which suggests agreement in six of the nine factors analyzed. There was disagreement between the groups in only three factors: anorexia, diarrhea and radiological changes.

Table 3. Associated factors between groups.

Factor Analyzed

Group 1

Group 2

n

Position

n

Position

Migration of pain

359

27

Anorexia*

96

2

Nausea/vomiting

274

24

PD+

246

23

Fever (> 37.3)

163

21

Diarrhea *

47

7

X-ray Change *

71

13

US Change

87

12

CT Change

76

8

W=0.88 (p=0.0684) * discordant factors; PD+: sudden painful decompression; US: ultrasound; CT: computed tomography.

To evaluate the duration of the main complaint (abdominal pain) and to compare the control and study groups, we used the Mann-Whitney test, with which we could observe that the duration of the signs and symptoms in days of group 2 was significantly higher than group 1 (p=0.05), as seen in table 4. Table 4. Duration of the main complaint among groups.

Median Average

Duration of Symptoms Group 1 Group 2 1.5 3 2.5 3.5 Z=3.68 (p=0.0002)

DISCUSSION Studies have shown that the worst prognosis in acute appendicitis occurs in elderly patients with associated comorbidities, as well as a longer time of disease evolution and the occurrence of appendicular perforation11. The complications found in patients undergoing appendectomy are usually related to the stage at which the disease is diagnosed and treated. Studies by Petroianu et al.6 with regard to the appendicitis

morphological classification indicated that among 170 patients studied, 23 were in the catarrhal phase, 99 in the fibrinopurulent phase, 31 in gangrenous, and 17, in the perforation phase. This study confirmed the relationship between complications and appendicitis phase, since 45% of the patients in the complications group had appendicitis perforation. And in the control group (without complications) the phlegmonous phase predominated (38%). As expected, the study group had a considerably longer hospital stay than the control group, 13.2 days, as observed in our cases. According to Fischer et al.12, in a total of 272 appendectomies evaluated, of which 88 (32.3%) in the catarrhal phase, 79 (29%) in the phlegmonous phase, 70 (25.3%) in the suppurative phase and 35 (12,8%) in gangrenous phase, the mean time of hospitalization was 4.3 days (2 to 36 days). Reis et al.7 analyzed the anatomopathological evolution of 300 cases of acute appendicitis and observed that the phlegmonous form predominated (71.3%). In 63 cases, characteristic perforation of the gangrenous form occurred. Mendoza et al.13 studied 113 patients submitted to appendectomy, 55.8% men and 44.2% women, with a mean age of 28.2 years (6 to 86). The du-

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ration of symptoms was 12h in 22.1%, 12 to 24h in 31.8%, 24 to 48h in 33.6%, 48 to 72h in 10.6% and more than 72h in 1.7%. They observed 19 patients in the edematous stage, 41 patients in the phlegmonous one, 22 in the gangrenous phase, four in the perforated stage and 6 in the perforated phase with peritonitis. The remaining 21 had normal appendices. Petroianu et al.6 identified that the radiographic sign of fecal accumulation in the cecum was present in 165 of the 170 patients with acute appendicitis. The radiographic signal sensitivity for acute appendicitis was 97% and its specificity was 85.3%. The positive predictive value of this signal for acute appendicitis was 78.9%, while its negative predictive value stands out with 98%. Another study, however, showed that simple x-ray of the abdomen should not be required, since it has low specificity and sensitivity, while US has sensitivity of 75 to 90% and specificity of 86 to 100%, but it depends on a qualified operator1. Studies with US showed that its sensitivity ranged from 68 to 96%, and specificity, from 46.7 to 95.9%, with PPV between 82.2 and 94% and accuracy from 65.7 to 87%14-17. CT has sensitivity and specificity of 90 to 100% and 91 to 99%, respectively. Studies showed its sensitivity ranging from 91.2 to 98.5%, specificity from 62.5 to 98%, positive predictive value (PPV) from 92.1 to 98% and accuracy of 90%16-20. CT findings consist of appendix lumen dilation, thickening of the wall, presence of fecalites and inflammation1. In our sample, 72% of the patients in the study group and 68% of the patients in the control group were not submitted to CT, since it was possible to confirm the diagnosis by other methods such as simple radiographs and US, which, when positive, were considered risk factors associated with complications. Although the literature highlights CT as a method of choice in the diagnosis of appendicitis, this tool is not always available. Lima et al.14 observed a higher prevalence of appendicitis in young adults (60%), with a predominance of males. The mean length of hospital stay was seven days, with no significant differences between genders. The most frequent evolutionary phase was phase II with 34.3%. Of the patients diagnosed in stage IV, 65.8% were men. The hospitalization time was

higher in this phase, with a mean of 12.4 days, with a significant difference between phase I and phase IV (p=0.001). Eighty-one patients used drains for an average of 4.8 days and the mean length of hospital stay was 10.4 days. Of the patients studied, 196 were submitted to amoxycillin/clavulanate antibiotic prophylaxis only in 64.3% of the cases. These patients had shorter hospitalization time compared to those who did not undergo prophylaxis. Thirty-eight patients (5.9%) developed postoperative complications, with wound infection (52.6%) and wound dehiscence (26.3%) being the most frequent. There were also complications due to intra-abdominal abscess, sepsis and fistula. Seventeen patients died (2.7%). Among them, the majority were male, mean age was 38.4 years, 70.6% had complicated AA and 47% were diagnosed in stage IV, with a direct correlation between the evolutionary stage and death. Regarding death causes, 53% were due to septic shock and 47% to unknown or indeterminate causes. Despite new and better antibiotics, advances in imaging and supportive care, a large number of patients with acute appendicitis develop serious complications and have morbid and prolonged recoveries8. Silva et al.2 considered surgical wound infections and intraabdominal abscesses as the main morbidity factors and that the perforated phase contributed to the increase of such complications. The main risk factors for complications after appendectomies were: female gender, necrotic or perforated appendicitis and cavity drainage. A recent study showed that the perforation rate of patients with appendicitis was 16%. The mean duration from onset of symptoms to hospital admission was 4.4 days. The factors that contributed to the appendix perforation included a diagnostic error and initial patient approach (56%), delayed hospitalization (11%) and use of analgesics (9%)21. In our study, we observed a relationship between the complications and the appendicitis phase. We also found a relationship between the duration of symptoms and the development of complications. It is known that the longer the duration of signs and symptoms, the greater the risk of appendix perforation and, consequently, of postoperative complications2. These results reinforce the importance of

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anamnesis, physical examination and complementary methods in the diagnosis of acute appendicitis, especially in the presence of risk factors for complications:

patients below 12 years of age, presence of fever, PD+, diarrhea, imaging exams alterations, as well as the long duration of signs and symptoms.

R E S U M O Objetivo: identificar os principais fatores de risco associados ao desenvolvimento de complicações em pacientes portadores de apendicite aguda. Métodos: estudo caso controle de dados dos prontuários de 402 pacientes internados com apendicite aguda em um hospital de nível secundário, separados em dois grupos: grupo controle, com 373 pacientes que evoluíram sem complicações pós-operatórias (Grupo 1) e grupo estudo, com 29 pacientes que apresentaram complicações (Grupo 2). Foram avaliados dados demográficos, sinais e sintomas da doença, exames de imagem e dados da internação. Resultados: os fatores associados às complicações foram febre, alterações radiológicas e ultrassonográficas, descompressão brusca positiva e diarreia. Migração da dor, náuseas, vômitos e descompressão brusca positiva foram os achados significativamente mais frequentes nos dois grupos (p=0,05). Já a duração dos sinais e sintomas, em dias, no grupo 2 foi significativamente maior que no grupo 1, com mediana de três dias para o grupo com complicações (p=0,05). Conclusão: alterações nos exames de imagem, febre, diarreia, descompressão brusca positiva, tempo de duração de sintomas e menor faixa etária estão associados à maior frequência de complicações na apendicite aguda, o que reforça a importância da anamnese, do exame físico e da indicação de exames complementares na abordagem desses pacientes. Descritores: Apendicite. Apendicectomia. Complicações Intraoperatórias. Diagnóstico.

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da apendicite aguda: análise retrospectiva de 638 casos. Rev Col Bras Cir. 2016;43(4):248-53. Nutels DBA, Andrade ACG, Rocha AC. Perfil das complicações após apendicectomia em um hospital de emergência. ABCD Arq Bras Cir Dig. 2007;20(3):146-9. Ozkan S, Duman A, Durukan P, Yildirim A, Ozbakan O. The accuracy rate of Alvarado score, ultrasonography, and computerized tomography scan in the diagnosis of acute appendicitis in our center. Niger J Clin Pract. 2014;17(4):413-8. Shogilev DJ, Duus N, Odom SR, Shapiro NI. Diagnosing appendicitis: evidence-based review of the diagnostic approach in 2014. West J Emerg Med. 2014;15(7):859-71. Yildirim E, Karagülle E, Kirbas I, Türk E, Hasdoğan B, Teksam M, et al. Diagn Interv Radiol. 2008;14(1):148. Çağlayan K, Günerhan Y, Koç A, Uzun MA, Altinli E, Köksal N. The role of computerized tomography in the diagnosis of acute appendicitis in patients

with negative ultrasonography findings and a low Alvarado score. Ulus Travma Acil Cerrahi Derg. 2010;16(5):445-8. 20. Nanjundaiah N, Mohammed A, Shanbhag V, Ashfaque K, Priya SA. A comparative study of RIPASA score and ALVARADO score in the diagnosis of acute appendicitis. J Clin Diagn Res. 2014;8(11): NC03-5. 21. Öztürk A, Korkmaz M, Atalay T, Karaköse Y, Akinci ÖF, Bozer M. The role of doctors and patients in appendicitis perforation. Am Surg. 2017;83(4):390-3.

Received in: 23/05/2017 Accepted for publication: 20/07/2017 Conflict of interest: none. Source of funding: none. Mailing address: Tulio Fabiano de Oliveira Leite E-mail: tuliofabiano@hotmail.com / lucaspires@id.uff.br

Rev Col Bras Cir 2017; 44(6): 560-566


Original Article

DOI: 10.1590/0100-69912017006004

Perioperative synbiotics administration decreases postoperative infections in patients with colorectal cancer: a randomized, double-blind clinical trial A administração perioperatória de simbióticos em pacientes com câncer colorretal reduz a incidência de infecções pós-operatórias: ensaio clínico randomizado duplo-cego ALINE TABORDA FLESCH1; STAEL T. TONIAL1; PAULO DE CARVALHO CONTU1; DANIEL C. DAMIN1. A B S T R A C T Objective: to evaluate the effect of perioperative administration of symbiotics on the incidence of surgical wound infection in patients undergoing surgery for colorectal cancer. Methods: We conducted a randomized clinical trial with colorectal cancer patients undergoing elective surgery, randomly assigned to receive symbiotics or placebo for five days prior to the surgical procedure and for 14 days after surgery. We studied 91 patients, 49 in the symbiotics group (Lactobacillus acidophilus 108 to 109 CFU, Lactobacillus rhamnosus 108 to 109 CFU, Lactobacillus casei 108 to 109 CFU, Bifi dobacterium 108 to 109 CFU and fructo-oligosaccharide (FOS) 6g) and 42 in the placebo group. Results: surgical site infection occurred in one (2%) patient in the symbiotics group and in nine (21.4%) patients in the control group (p=0.002). There were three cases of intraabdominal abscess and four cases of pneumonia in the control group, whereas we observed no infections in patients receiving symbiotics (p=0.001). Conclusion: the perioperative administration of symbiotics significantly reduced postoperative infection rates in patients with colorectal cancer. Additional studies are needed to confirm the role of symbiotics in the surgical treatment of colorectal cancer. Keywords: Synbiotics. Infection. Colorectal Surgery. Colorectal Neoplasms. Clinical Trial.

INTRODUCTION

D

espite the recent advances in colorectal surgery, such as the use of minimally invasive surgery techniques and improvements in postoperative care, the incidence of postoperative infectious complications remains high. Surgical site infection (SSI) is particularly common, with incidence rates varying from 5% to 26%1,2. This seems to result, in part, from microflora imbalances and interruption of the intestinal barrier3,4. Studies of different gastrointestinal procedures, including pancreaticoduodenectomy, hepatobiliary resection and liver transplantation, suggest that the use of symbiotics may represent a promising approach for the prevention of postoperative infections5-7. Symbiotics are compounds formed by the combination of prebiotics and probiotics. Prebiotics are nondigestible food components that selectively alter the growth and activity of colonic bacteria. Probiotics are viable bacteria used to regulate the balance of intestinal microflora8,9. Although the colon is

an important reservoir for commensal microorganisms, the use of symbiotics in colorectal surgery is controversial10-12. The objective of this study was to evaluate the effect of perioperative administration of symbiotics on the incidence of postoperative infection in patients submitted to a potentially curative surgical resection of colorectal cancer.

METHODS This is a randomized, double-blinded, placebo-controlled trial. The study was conducted by the Coloproctology Service of the Porto Alegre Clinics Hospital between June 2013 and April 2015. Patients with histologically proven colorectal adenocarcinoma with indication of elective and potentially curative colorectal resection were considered eligible to participate in the study. Exclusion criteria were pregnancy, patient’s difficulties regarding adequate understanding of the

1 - Federal University of Rio Grande do Sul, Post-Graduation Program in Surgical Sciences, Porto Alegre, RS, Brazil. Rev Col Bras Cir 2017; 44(6): 567-573


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Flesch Perioperative synbiotics administration decreases postoperative infections in patients with colorectal cancer: a randomized, double-blind clinical trial

study, neoadjuvant treatment (chemotherapy and radiotherapy), previous use of products with prebiotic, probiotic and/or symbiotic function or fiber modulus, and refusal to participate. We also excluded from the analysis patients with tumors that were considered non-resectable during surgery and those who had other organs resected concomitantly (uterus, bladder, liver, spleen). The present study was performed after approval by the Ethics in Research Committee of the Porto Alegre Clinics Hospital, protocol number 12.0284. We obtained an informed consent term from all patients before inclusion. This work was entered in the ClinicalTrials.gov registry (identifier NCT01468779) and followed the recommendations of the Consolidated Standards of Reporting Trials (CONSORT 2010).

Groups of study Preoperative assessment of the patients included a complete clinical history and physical examination, carcinoembryonic antigen dosage, colonoscopic examination, computed tomography of the abdomen and pelvis and chest X-ray and/or computed tomography of the chest. In addition, all patients underwent subjective global assessment (SGA) and anthropometric assessments13. We randomly allocated patients in the intervention group (symbiotic) or in the control group (placebo). Both were given two sachets twice a day containing the active substance (intervention group) or placebo (control group) for five days before the surgical procedure and for 14 days after surgery. The intervention group received sachets containing Lactobacillus acidophilus NCFM (109), Lactobacillus rhamnosus HN001 (109), Lactobacillus paracasei LPC-37 (109), Bifidobacterium lactis HN019 (109) and fructo -oligosaccharides (FOS) 6g. The control group received sachets containing 96% maltodextrin 100% (6g). The sachets for both groups had the same appearance and the substances had the same color and flavor. The pharmacist, exclusively involved in the manufacturing of the symbiotics and placebo, randomized patients using a computer-generated sequence of numbers.

Both the investigators and the patients were blinded as to to group allocation until the end of the test. However, blinding could be disrupted if patients had severe adverse events that might be related to the product being investigated. On the day before surgery, all patients underwent routine bowel preparation. They also received intravenous gentamicin and metronidazole one hour before surgery.

Clinical variables Postoperative infection was defined as infection occurring within 30 days of surgery. Infections were classified as incisional (surgical wound), organ/space (where surgery was performed) or at a distant site (urinary tract infection, pneumonia). The length of hospital stay was defined as the number of days elapsed from surgery to discharge. Deaths occurring within 30 days of surgery were considered surgical.

Statistical analysis The sample size was based on a previous study that found a reduction in infection rates from 40% to 12.5% after administration of symbiotics14. For a statistical power of 80% and an expected sampling loss rate of 10%, the sample size would be 90 patients. The sample size calculations were done with the COMPARE2 1.72 software. We analyzed the data with the Statistical Program for Social Sciences program version 20.0 (SPSS Inc., Chicago, IL, USA, 2008) for Windows. We studies continuous variables using the Kolmogorov-Smirnov test. For the bivariate analysis of categorical variables, we used the Pearson Chi-square test or the Fisherâ&#x20AC;&#x2122;s Exact Test. For continuous variables, when comparing two independent groups, were applied the Studentâ&#x20AC;&#x2122;s t or the Mann Whitney U test . We set the level of significance at p<0.05.

RESULTS We initially included one hundred patients in the study. Of these, were excluded nine: four with unresectable tumors and five patients who required concomitant resection of other organs. After exclusions, the

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Flesch Perioperative synbiotics administration decreases postoperative infections in patients with colorectal cancer: a randomized, double-blind clinical trial

intervention group (symbiotics) consisted of 49 patients and the control group (placebo), of 42. Both groups were

569

similar, showing no statistical differences in demographic and clinical characteristics (Table 1).

Table 1. Variables evaluated.

Groups Variรกveis Age (years) BMI (kg/m2) Gender Female Male Diabetes Cardiovascular Disease

Intervention (n=49) n % 64.5 11.4 26.57 3.8

P Control (n=42)

n

%

61.1 25.7

13.4 5.3

0.192 0.353 0.542

31 18 9

54.8 45.2 21.4

23 19 12

63.3 36.7 24.5

0.924

29

60.4

19

36.6

0.264

Lung Disease

5

10.2

5

11.9

1.0

Other Albumin Below 3.5mg/dl Greater than or equal to 3.5mg/ dl ASA I II III IV Ostomies Rehospitalization Type of surgery Open Laparoscopic/ Robotic Tumor location Rectum Colon Tumor stage I II III IV Subjective Global Assessment A B

16

36.7

12

28.6

0.847 0.100

8

16.3

2

4.8

41

83.7

40

95.2

8 35 6 0 22 5

16.3 71.4 12.2 0 44.9 10.20

12 28 2 0 20 5

28.3 66.7 4.8 0 47.6 11.9

43

87.75

35

83.33

6

12.24

7

16.66

0.259

0.961 1.0 0.872

1.0 28 21

53.8 42.9

24 18

57.1 42.9 0.146

14 20 14 1

28.6 40.8 28.6 2

11 20 6 5

26.2 47.6 14.3 11.9 0.764

43 6

87.8 12.2

35 7

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83.3 16.7


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Flesch Perioperative synbiotics administration decreases postoperative infections in patients with colorectal cancer: a randomized, double-blind clinical trial

Only one patient in the symbiotics group presented surgical wound infection, while nine cases were diagnosed in the control group (p=0.002). There was also a significant difference between the groups in relation to other infectious complications. While we observed three cases of intraabdominal abscess and four cases of pneumonia in the control group, we diagnosed no cases in the symbiotics group (p=0.001). The incidence of noninfectious postoperative complications such as nausea, vomiting, abdominal distension, ileus, diarrhea or constipation was not different between the study groups (p=0.161). The mean hospitalization time was 11.2 days for the patients in the symbiotics group and 12.69 days for the patients in the control group was, with no statistical significance. There were no significant differences between the groups regarding mortality rates and re-hospitalization.

DISCUSSION Recent clinical studies have evaluated the effect of immunomodulatory diets with probiotics and symbiotics on the incidence of infections related to different gastrointestinal surgeries. Promising results were demonstrated in resections of the pancreas, liver and esophagus5-7,15. Regarding colorectal resections, however, the results so far have been conflicting due to differences in the populations studied, type of surgery, type of probiotics and symbiotics used, and analysis methodology11,12,16,17. Our study is the first to evaluate the effect of symbiotics not only on cancer patients undergoing minimally invasive colorectal surgery, including robotic and laparoscopic resections, but also in patients undergoing conventional open colorectal surgery. In this sense, we prospectively evaluated a homogeneous population of patients with histologically confirmed colorectal adenocarcinoma submitted to elective and potentially curative oncological resection. We decided not to include patients undergoing surgery for benign colorectal diseases, considering the particular nutritional and immunological aspects of patients with colorectal cancer. Patients submitted to resection of multiple adjacent organs were excluded,

as these surgeries are generally more extensive and related to increased morbidity. In addition, patients whose tumors were considered non-resectable were excluded. As shown in table 1, after patients randomization, we ended the study groups with similar clinical and demographic characteristics. Because of the nature of colorectal surgery, infectious complications, especially wound infections, are extremely common, with a negative impact on quality of life, length of hospitalization, and costs. In this study, the perioperative use of symbiotics significantly reduced the incidence of wound infection. Among the functions of the symbiotic compounds, the best characterized is the increase of the resistance of the strains against pathogens. Probiotic cultures compete with pathogenic microorganisms, whose growth is inhibited by the production of organic acids (lactate, propionate, butyrate and acetate), reinforcing the natural defense mechanisms of the body18-20. Modulation of the intestinal microbiota by probiotic microorganisms occurs through a mechanism called â&#x20AC;&#x153;competitive exclusionâ&#x20AC;? and the strains that beneficially act in such cases are Bifidobacterium bifidum, Lactobacillus rhamnosus, Saccharomyces boulardii and Lactobacillus plantarum21. The effect of probiotics on the immune response has also been demonstrated. Evidence in in vitro systems and animal models suggest that probiotics stimulate nonspecific and specific immune response. These effects are mediated by the activation of macrophages through an increase in cytokine levels and natural killer cell (NK) activity. The intestinal mucosa is the bodyâ&#x20AC;&#x2122;s first line of defense against pathogenic invasions and action of toxic elements. After ingestion, the antigens encounter the GALT (gut-associated lymphoid tissue), which represents a mechanism of protection against pathogens. It also prevents the proteic hyperstimulation of the immune response through a mechanism known as tolerance to ingested content. The main protective mechanism of GALT is the humoral immune response mediated by IgA secretion, which prevents the entry of potentially harmful antigens, while at the same time interacting with pathogens of the mucosa without increasing the damage. Numerous studies have shown that some probiotic

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Flesch Perioperative synbiotics administration decreases postoperative infections in patients with colorectal cancer: a randomized, double-blind clinical trial

strains can increase S-IgA and modulate the production of cytokines involved in the regulation, activation, growth and differentiation of immune cells. It should be emphasized that the beneficial effects of probiotics on the immune system occur without triggering a harmful inflammatory response. However, not all lactic acid bacterial strains are equally effective. The immune response may be increased when one or more probiotics are consumed simultaneously and act synergistically, as appears to be the case with Lactobacillus given in conjunction with Bifidobacterium (SAAD), which we used in this study22-24. In our study, the use of symbiotics also reduced the incidence of remote infections such as pneumonia, which only occurred in the control group. This finding is in line with the results of a meta-analysis conducted by Yang et al.25 that analyzed 28 randomized trials involving 2511 patients undergoing different abdominal surgeries, including esophagectomies, pancreatectomies, hepatectomies, liver transplants and colectomies. The incidence of infections was lower among patients receiving symbiotics than in controls, particularly for respiratory, urinary, and wound infections. Hospitalization time was also shorter in patients receiving symbiotics. In our study, however, there was no difference between groups in relation to the length of hospital stay. He et al.11 carried out a specific meta-analysis to estimate the probiotic/symbiotic treatment efficacy in patients undergoing colorectal resection. Only six randomized clinical trials involving 361 patients were included. Two studies aimed at preoperative use of probiotics or symbiotics, a study on postoperative treatment, and three evaluated pre and postoperative treatment. In addition to the differences in the products used, there was also heterogeneity between studies in the inclusion criteria and the types of sur-

571

gery performed. The pre or perioperative administration of symbiotics had a positive effect on the incidence of total surgical infections and pneumonia. More recently, Komatsu et al.9 performed a randomized, controlled, unicentric study, including patients undergoing elective laparoscopic colorectal surgery. A total of 379 patients were randomly assigned to two groups: 173 in the symbiotics group and 206 in the control group. After applying selection criteria, 362 patients (168 of the symbiotic group and 194 for the control group) were considered eligible for the study. Infection occurred in 29 (17.3%) patients of the symbiotics group and in 44 (22.7%) of the control group. According to the authors, symbiotics were not an effective treatment to reduce the incidence of infectious complications after colorectal resection. In our study, we included not only patients submitted to minimally invasive surgeries, but also conventional open surgeries, which represented the majority of our cases. One of the potential advantages of minimally invasive surgery is less surgical trauma, with less acute inflammatory response and immune disorders. All infection cases occurred among patients undergoing open surgery, which suggests that the symbiotics effect is more important in this type of surgery. We observed, therefore, that the perioperative administration of symbiotics in patients submitted to elective surgery for colorectal cancer significantly reduced the rates of postoperative infection. Our results suggest that preoperative and postoperative oral ingestion of symbiotics may represent a promising strategy to prevent surgical infections in patients with colorectal cancer. Additional studies are needed to confirm the role of these microorganisms in colorectal surgery.

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Flesch Perioperative synbiotics administration decreases postoperative infections in patients with colorectal cancer: a randomized, double-blind clinical trial

R E S U M O Objetivo: avaliar o efeito da administração perioperatória de simbióticos na incidência de infecção de ferida operatória em pacientes operados por câncer colorretal. Métodos: ensaio clínico randomizado de pacientes com câncer colorretal submetidos à cirurgia eletiva e aleatoriamente designados para receberem simbióticos ou placebo por cinco dias antes do procedimento cirúrgico e por 14 dias após a cirurgia. Noventa e um pacientes foram estudados: 49 para o grupo de simbióticos (Lactobacillus acidophilus 108 a 109 UFC, Lactobacillus rhamnosus 108 a 109 UFC, Lactobacillus casei 108 a 109 UFC, Bifi dobacterium 108 a 109 UFC e fruto-oligosacarídeos (FOS) 6g) e 42 para o grupo placebo. Resultados: infecção de sítio cirúrgico ocorreu em um (2%) paciente no grupo de simbióticos e em nove (21,4%) pacientes no grupo controle (p=0,002). Três casos de abscesso intra-abdominal e quatro casos de pneumonia foram diagnosticados no grupo controle, enquanto não foram observadas tais infecções em pacientes que receberam simbióticos (p=0,001). Conclusão: a administração perioperatória de simbióticos reduziu significativamente as taxas de infecção pós-operatória em pacientes com câncer colorretal. Estudos adicionais são necessários para confirmar o papel dos simbióticos no tratamento cirúrgico do câncer colorretal. Descritores: Simbióticos. Infecção. Cirurgia Colorretal. Neoplasias Colorretais. Ensaio Clínico.

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Fusco Sde FB, Massarico NM, Alves MV, Fortaleza CM, Pavan EC, Palhares Vde C, et al. [Surgical site infection and its risk factors in colon surgeries]. Rev Esc Enferm USP. 2016;50(1):43-9. Portuguese. de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009;37(5):387-97. Howard DD, White CQ, Harden TR, Ellis CN. Incidence of surgical site infections postcolorectal resections without preoperative mechanical or antibiotic bowel preparation. Am Surg. 2009;75(8):659-63. Fooks LJ, Gibson GR. Probiotics as modulators of the gut flora. Br J Nutr. 2002;88 Suppl 1:S39-49. Rayes N, Seehofer D, Hansen S, Boucsein K, Müller AR, Serke S, et al. Early enteral supply of lactobacillus and fiber versus selective bowel decontamination: a controlled trial in liver transplant recipients. Transplantation. 2002;274(1):123-7. Kanazawa H, Nagino M, Kamiya S, Komatsu S, Mayumi T, Takagi K, et al. Synbiotics reduce postoperative infectious complications: a randomized controlled trial in biliary cancer patients undergoing hepatectomy. Langenbecks Arch Surg. 2005;390(2):104-13. Sommacal HM, Bersch VP, Vitola SP, Osvaldt AB. Perioperative synbiotics decrease postoperative complications in periampullary neoplasms: a randomized, double-blind clinical trial. Nutr Cancer. 2015;67 (3):457-62.

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Flesch AG, Poziomyck AK, Damin DC. The therapeutic use of symbiotics. Arq Bras Cir Dig. 2014;27(3):2069. Komatsu S, Sakamoto E, Norimizu S, Shingu Y, Asahara T et al. Efficacy of perioperative synbiotics treatment for the prevention of surgical site infection after laparoscopic colorectal surgery: a randomized controlled trial. Surg Today. 2016;46(4):479-90. Denipote FG, Trindade EB, Burini RC. [Probiotics and prebiotics in primary care for colon cancer]. Arq Gastroenterol. 2010;47(1):93-8. Portuguese. He D, Wang HY, Feng JY, Zhang MM, Zhou Y, Wu XT. Use of pro-/synbiotics as prophylaxis in patients undergoing colorectal resection for cancer: a metaanalysis of randomized controlled trials. Clin Res Hepatol Gastroenterol. 2013;37(4):406-15. Horvat M, Krebs B, Potrc S, Ivanecz A, Kompan L. Preoperative synbiotic bowel conditioning for elective colorectal surgery. Wien Klin Wonchenschr. 2010;122 Suppl 2:26-30. Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, et al. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987;11(1):8-13. Sommacal HM, Bersch VP, Vitola SP, Osvaldt AB. Perioperative synbiotics decrease postoperative complications in periampullary neoplasms: a randomized, double-blind clinical trial. Nutr Cancer. 2015;67(3):457-62. Tanaka K, Yano M, Motoori M, Kishi K, Miyashiro I, Ohue M, et al. Impact of perioperative administration of synbiotics in patients with

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esophageal cancer undergoing esophagectomy: a prospective randomized controlled trial. Surgery. 2012;152(5):832-42. Anderson AD, McNaught CE, Jain PK, MacFie J. Randomised clinical trial of synbiotic therapy in elective surgical patients. Gut. 2004;53(2):241-5. Reddy BS, Macfie J, Gatt M, Larsen CN, Jensen SS, Lese TD. Randomized clinical trial of effect of synbiotics, neomycin and mechanical bowel preparation on intestinal barrier function in patients undergoing colectomy. Br J Surg. 2007;94(5):54654. Chan YK, Estaki M, Gibson DL. Clinical consequences of diet-induced dysbiosis. Ann Nutr Metab. 2013;63 Suppl 2:28-40. Kinross JM, Markar S, Karthikesalingam A, Chow A, Penney N, Silk D, et al. A meta-analysis of probiotic and synbiotic use in elective surgery: does nutrition modulation of the gut microbiome improve clinical outcome? JPEN J Parenter Enteral Nutr. 2013;37(2):243-53. Gibson GR, Roberfroid MB. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 1995;125(6):1401-12. Barrenetxe J, Aranguren P, Grijalba A, MartínezPeñuela JM, Marzo F, Urdaneta E. Modulation of gastrointestinal physiology through probiotic strains of Lactobacillus casei and Bifidobacterium bifidum. An Sist Sanit Navar. 2006;29(3):337-47.

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22. Delcenserie V, Martel D, Lamoureux M, Amiot J, Boutin Y, Roy D. Immunomodulatory effects of probiotics in the intestinal tract. Curr Issues Mol Biol. 2008;10(1-2):37-54. 23. Gaudier E, Michel C, Segain JP, Cherbut C, Hoebler C. The VSL#3 probiotic mixture modifies microflora but does not heal chronic dextran-sodium sulfateinduced colitis or reinforce the mucus barrier in mice. J Nutr. 2005;135(12):2753-61. 24. Gillor O, Etzion A, Riley MA. The dual role of bacteriocins as anti- and probiotics. Appl Microbiol Biotechnol. 2008;81(4):591-606. 25. Yang Z, Wu Qsimbioticos, Liu Y, Fan D. Effect of perioperative probiotics and synbiotics on postoperative infections after gastrointestinal surgery: a systematic review with meta-analysis. JPEN J Parenter Enteral Nutr. 2016:148607116629670. [Epub ahead of print].

Received in: 07/06/2017 Accepted for publication: 20/07/2017 Conflict of interest: none. Source of funding: none. Endereço para correspondência: Daniel C. Damin E-mail: damin@terra.com.br / ddamin@hcpa.edu.br

Rev Col Bras Cir 2017; 44(6): 567-573


Original Article

DOI: 10.1590/0100-69912017006005

Brief hospitalization protocol for pressure ulcer surgical treatment: outpatient care and one-stage reconstruction Protocolo de internação breve para tratamento cirúrgico de lesões por pressão: preparo ambulatorial e cobertura em tempo único DIMAS ANDRÉ MILCHESKI1; ROGÉRIO RAFAEL DA SILVA MENDES1; FERNANDO RAMOS DE FREITAS1; GUILHERME ZANINETTI1; ARALDO AYRES MONEIRO JÚNIOR1; ROLF GEMPERLI, TCBC-SP1. A B S T R A C T Objective: to evaluate a brief hospitalization protocol for the treatment of pressure ulcers, proposed by the Complex Wound Group of Clinical Hospital of University of Sao Paulo Medical School, particularly in regard to selection of patients, hospitalization time, cutaneous covering, complications and sore recurrence. Methods: retrospective cohort of 20 consecutive patients with 25 pressure lesions Grade IV. All patients were ambulatorily prepared and were hospitalized for surgical one time procedure for pressure lesion closing. Results: in total, 27 flaps were performed to close 25 wounds. Three patients showed minor dehiscence (11.1%). There was no recurrence during the post-surgical follow-up period. No patient suffered a new surgery and no flap showed partial or total necrosis. Median time of hospitalization was 3.6 days (2-6 days) and median follow-up was 91 months (2-28 months). All patients maintained their lesions closed, and there was no recurrence during follow-up. Conclusion: the brief hospitalization protocol was considered adequate for the resolution of pressure wounds, showing an average time of hospitalization of 3.6 days and rate of minor surgical wound dehiscence of 11.1%. Keywords: Pressure Ulcer. Wounds and Injuries. Surgical Flaps. Surgery, Plastic.

INTRODUCTION

T

reatment of complex wounds is part of the job of the Plastic Surgeon. Population aging and complications of diseases such as diabetes and neurological disturbances are relevant to the occurrence of such wounds. Among several causes, pressure ulcers/sores may be highlighted, resulting from continuous ischemia over bone prominences1,2. Usually, they are observed in paralysed or unconscious patients that cannot feel or respond to periodic need of repositioning3. Preventive measures include identification of high risk patients and their constant clinical evaluation, programmed repositioning, use of mattress that relief pressure and of barriers to local moisture, and correct nutrition. Prevention of such lesions directly reflects hospital care and multidisciplinary coordinated approach of health teams4. The National Pressure Ulcer Advisory Panel (NPUAP), in 1989, proposed a classification of pressure ulcers that was revised in 20075. It considers the depth

of tissue damage, exposition of deep structures (muscles, tendons, bones) and the presence of contamination and slough. The classification ranges from I to IV and the highest score is related to lesions with loss of total tissue thickness, exposing muscles and bones. At Clinicas Hospital of the University of São Paulo (HC-FMUSP) (São Paulo, Brazil), the Group for treatment of complex wounds is part of Plastic Surgery Department and attends patients with pressure wounds at the Emergency Room, Hospital or Ambulatory. Over the last years, it has been observed an increase of referred patients to our Ambulatory with pressure ulcers. In response to that, a protocol for pre-operatory care of patients was developed by the plastic surgery team for the treatment of pressure lesions with good clinical conditions that could be taken care with a short period of hospitalization, in order to provide a one-stage surgery for closure of wounds. The objective of the present study was to evaluate a brief hospitalization protocol for the treatment of pressure wounds proposed by the Complex

1 - Faculty of Medicine, University of São Paulo, Plastic Surgery Division, Hospital das Clínicas, São Paulo, SP, Brasil. Rev Col Bras Cir 2017; 44(6): 574-581


Milcheski Brief hospitalization protocol for pressure ulcer surgical treatment: outpatient care and one-stage reconstruction

575

Wound Group of HC-FMUSP with emphasis on the patients selection, period of hospitalization, type of cutaneous covering, complications and recurrence of wounds.

METHODS This was a retrospective cohort study that evaluated 20 consecutive patients with 25 grade IV lesions. They were treated from 2016 to 2017 at ambulatory and admitted according to the brief hospitalization protocol for surgical treatment, with the following selection criteria: Grade IV pressure wounds; Albumin >3.0; Hemoglobin >10.0; Controlled spasticity; Clean wound, with borders showing regression; Absence of clinical signals and/or image exams suggesting osteomyelitis; Familial or caregiver support. Patients were followed-up at ambulatory after discharge for evaluation of: healing/absence of dehiscence (up to 30 days) or recurrence (more than 30 days). Minor dehiscence was considered when it was possible to treat with ambulatory dressings and it was considered major when it was necessary a new surgery. Patients that did not match the inclusion criteria were excluded as well as those with loss of postoperative follow-up. Patients with comorbidities or who smoked were not excluded. Regarding surgical technique, it followed a standard procedure: extended bursectomy and debridement until a clinically viable bone was reached; these were followed by immediate reconstruction with a fasciocutaneous loco-regional flap. An exception was made to trochanteric lesions that were covered with a miocutaneous fascia lata tensor flap (Figure 1). The performed flaps had about 20% to 40% of their extent de-epidermised and they were inserted inside the wound for bone protection and filling of the dead space. All patients were drained and samples of deep bone tissue were sent to pathological analysis, in order to rule out the presence of chronic osteomyelitis and to guide post -operatory antibiotic therapy. Patients with pressure lesions in more than one location were treated according to the possibility of alternate decubitus during post-operatory period for adequate recovery and avoidance of new wounds.

Figure 1. Trochanteric pressure ulcer.

(Patient 3)- Trochanteric pressure lesion. A) marking of fascia lata tensor miocutaneous flap; B) extensive cavity defect after bursectomy; C) partial resection of trochanter; D) the flap was resected and de-epidermised for filling the defect; E) immediate post-operatory with covering and filling the defect; F) two months post-operatory.

RESULTS Median age of patients was 38.1 years (2275 years old). Seventeen patients (85%) were male and three (15%) female. Fifteen patients (75%) were paraplegic, three tetraplegic (15%) and two (10%) presented a chronic degenerative disease that caused immobilization. Median hemoglobin level was 13.1g/dl (10.3 to 15.5), and median albumin was 4.0g/dl (3.1 to 4.7). Five patients used drugs to control spasticity (25%). Controlled spasticity is related to the ability of patients to change and maintain a different decubitus. No patients had been previously submitted to surgical treatment of their wounds. Epidemiological data of each operated patient are listed at table 1. Results of surgical procedures are listed at table 2. In total, 27 flaps were made to cover 25 wounds. Among these, 3 (11.1%) showed minor dehiscence (treated only with ambulatory dressings) and one hematoma (3.7%) without the need of surgical drainage. There were no recurrences at follow up period. No patient suffered a new surgery and no flap presented partial or total necrosis (Figure 2). Bone sample analysis after surgical debridement were positive in five patients. They received prolonged antibiotic therapy according to sensitivity and none presented surgical wound infection or dehiscence. Among five patients with spasticity, one presented minor dehiscence and another a hematoma at post-operatory period (treated conservatively).

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576 Table 1. Epidemiological data of operated patients.

Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 Patient 7 Patient 8 Patient 9 Patient 10 Patient 11

Age 35 28 75 31 37 22 24 69 31 22 24

Gender M M F M F M M M M M M

Patient 12

40

M

Patient 13

54

M

Patient 14 Patient 15 Patient 16 Patient 17 Patient 18 Patient 19 Patient 20

62 24 30 28 43 35 49

M M M M F M M

Immobilization

Topography of the lesion

Paraplegia

Ischium and sacrum

Immobilization Sacrum Paraplegia Ischium and trochanter Paraplegia Sacrum and bilateral ischium Paraplegia Sacrum and unilateral ischium Immobilization Bilateral trochanter Paraplegia Sacrum Paraplegia Bilateral trochanter Paraplegia Ischium unilateral Tetraplegia Sacrum Paraplegia Sacrum and unilateral ischium Unilateral sacrum and Tetraplegia trochanter Sacrum, trochanter and Paraplegia unilateral ischium Paraplegia Sacrum and unilateral ischium Paraplegia Unilateral ischium Paraplegia Unilateral trochanter Paraplegia Bilateral ischium Tetraplegia Sacrum Paraplegia Bilateral ischium Paraplegia Unilateral ischium

Table 2. Surgical procedures.

Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 Patient 7 Patient 8 Patient 9 Patient 10 Patient 11 Patient 12 Patient 13 Patient 14 Patient 15 Patient 16 Patient 17 Patient 18 Patient 19 Patient 20

Lesion Ischium Sacrum Ischium and Unilateral Trochanter Bilateral Ischium Sacrum Trochanter Unilateral Trochanter Sacrum Bilateral Ischium Ischium Sacrum Sacrum Sacrum Sacrum Ischium Ischium Unilateral Trocanter Bilateral Ischium Sacrum Bilateral Ischium Ischium

Flap Posterior thigh VY Gluteus VY Posterior thigh VY + fascia lata tensor Bilateral posterior thigh VY Bilateral gluteus VY Fascia Lata tensor Gluteus VY Bilateral posterior thigh VY Posterior thigh VY Gluteus VY Bilateral gluteus VY Gluteus VY Gluteus VY Posterior thigh VY Posterior thigh VY Fascia Lata tensor Bilateral posterior thigh VY Gluteus VY Bilateral posterior thigh VY Posterior thigh VY

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Milcheski Brief hospitalization protocol for pressure ulcer surgical treatment: outpatient care and one-stage reconstruction

Medium time of hospitalization was 3.6 days (2-6 days), medium follow-up was 9.1 months (2-18 months). All patients maintained their wound closed and none of them showed recurrence during the follow-up period. Outcome data are described at table 3.

Figure 2. Ischiatic pressure lesion.

(Patient 9)- Ischiatic pressure lesion. A) marking of posterior fasciocutaneous thigh flap; B) defect after bursa resection; C) the flap was dissected and partially de-epidermised; D) inserted flap fixed at ischium periosteum for filling and protection; E) immediate post-operatory; F) one month of post-operatory with stable covering.

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DISCUSSION Over the last years it was observed an increase of referred patients to our ambulatory with pressure lesions; this can be explained by many reasons, such as no resolution of pressure sore during acute phase of hospitalization, recurrence of previous operated wounds, fail to follow guidelines of local care and change of decubitus, low socio-economic level of patients and absence of a caregiver to help with local care and change of decubitus. Pressure wounds have different prevalence according to countries and regions, maybe due to health local systems, HDI, per capita income, culture, etc. However, several location data show a relatively constant and convergent prevalence. In developed countries, risk patients have a prevalence of 1% to 50% (inpatients) and 8.3% (at home). In Germany, 21.2% of inpatients and 8.3% at home have pressure wounds. In the U.S.A., prevalence varies from 2% to 28% (medium 11%)6.

Table 3. Outcome data.

Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 Patient 7 Patient 8 Patient 9 Patient 10 Patient 11 Patient 12 Patient 13 Patient 14 Patient 15 Patient 16 Patient 17 Patient 18 Patient 19 Patient 20

Osteomyelitis

Complications

Hospitalization (days)

Follow-up (months)

Stable covering (1 month)

Yes No No Yes No Yes No Yes No Yes No No No No No No No No No No

No Dehiscence No No No No Hematoma No No No No No No No No No Dehiscence Dehiscence No No

4 2 2 4 4 4 4 4 4 5 6 4 3 6 3 6 2 2 2 2

18 16 15 14 14 12 12 11 10 9 9 8 7 6 6 4 4 3 2 2

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

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Milcheski Brief hospitalization protocol for pressure ulcer surgical treatment: outpatient care and one-stage reconstruction

In Brazil, pressure lesions prevalence is 16.9% for risk patients that rises to 39.4% for those with more than 60 years old. A study by the Federal University of Minas Gerais (UFMG) involving hospitals all over the country, studied 473 patients (251 men and 222 women) with 18 to 103 years old (medium 58.4 years); it observed pressure lesions in 80 patients (16.9%) with 137 ulcers. Among those patients, 47.4% had nutrition deficiency and 52.6% some grade of malnutrition7. Another aggravating factor is the immobilization grade of patient. The lowest the ability to move the higher the probability of a more severe lesions. Among tetraplegics and paraplegics, prevalence of pressure ulcers is 20% to 60%. Around 85% of patients with spinal cord injury may develop pressure lesions during treatment8,9. Most affected sites by pressure lesions are sacral and trochanteric regions. In a study by the Institute of Orthopedics and Trauma from HC-FMUSP including 45 patients, 32.5% of pressure lesions were sacral, 32.5% trochanteric, 15.5% involved ischium and 19.5% other regions. UFMG cited study included 137 lesions, and 66 (48.1%) were sacral, 30 (21.9%) trochanteric, 22 (16%) calcaneus and 21 (15.3%) involved other sites10. In our cohort, 46.8% of pressure sores were ischiatic, mainly in male patients (84%), adults at working age (medium 38.8 years) and paraplegics (73.5%). These data may represent a selection bias of the brief hospitalization protocol for patients with ischiatic lesions with better pre-operatory conditions. In general, two distinct epidemiologic population with pressure lesions are observed. One aged, with severe comorbidities (cardiopathies and neuropathies), with low level of conscience and lesions related to horizontal decubitus position (Figure 3). The other includes young patients, victims of spinal cord injury, usually paraplegics, with pressure lesions related to seated orthostatic position (wheelchairs). The first population presents mainly ulcers at sacrum and trochanter, and the other, at ischium (uni or bilateral). Initial treatment of these lesions include local pressure relief, improvement of spasms, usually frequent in these patients, enzymatic or surgical debridement, and maintenance of a clean and moistu-

re environment that allows for granulation and re-epithelization of the wound bed11. Approximately 70 to 90% of pressure ulcers are superficial and heal by second intention with these cares. Lesions Grades III and IV, deeper and occasionally associated with osteomyelitis, usually need surgical treatment, require covering with flaps for definitive treatment. In those patients, it is important to optimize home care (change of decubitus, local care) and nutritional status in order to increase surgical success12.

Figure 3. Sacral pressure ulcer.

(Patient 10)- Sacral pressure lesion. A) wound; B) defect after bursa resection; C) part resected; D) dissection and advance of gluteus fasciocutaneous V-Y flap; E) immediate post-operatory with covering of defect; F) six months of post-operatory with stable covering.

Our department chose to perform predominantly fasciocutaneous flaps routinely, since they provide adequate covering, good filling when de-epidermised and full irrigation of the wound, aiding infection control. Classically, the first option would be miocutaneous flaps, however, more recent papers showed similar quality of covering13. On the other side, muscular tissue is more sensitive to ischemia, increases operatory morbidity and prevents future use in case of recurrence14. This protocol selection variables and their cut-off values reflect the intention to perform the most successful resolutive surgery possible, with lower hospitalization time, and lower complication rate, in order to optimize the use of hospital beds and surgical rooms available. Grade IV pressure lesions were included due to the severity of these lesions that expose deep structures and need covering with flaps. In literature, hemoglobin level above 10g/dl is a very important cut-off, as well as serum albumin above

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Milcheski Brief hospitalization protocol for pressure ulcer surgical treatment: outpatient care and one-stage reconstruction

3.0g/dl, that reflect a good nutritional status related to lower rate of dehiscence of surgical wound15,16. The presence of spasticity in patients with pressure lesions is another important aspect17, since it difficult or prevents change of decubitus. These patients are at higher risk of presenting pressure ulcers, or recurrence in operated or healed areas. Usually, therapeutic options include baclofen associated or not with benzodiazepines. In the studied cohort, five patients were controlled with drugs. The absence at pre-operatory of osteomyelitis was also observed for inclusion of patients at the short hospitalization protocol, since it lowers surgical success rate18. In case of clinical (presence in inflammatory signs, fever, purulence) or laboratory (increase of leucocytes and PCR) suspicion, nuclear magnetic resonance was performed to confirm or rule out osteomyelitis. If positive, the patient was referred to Orthopedic Department for multidisciplinary treatment. If negative, the patient was included. At present, magnetic resonance is considered the best study for diagnosis of osteomyelitis19. However, the surgical protocol included partial resection of bone prominence to attenuate the pressure point that was sent to pathological analysis. Five samples were positive for osteomyelitis at post-operatory. The use and period of use of antibiotics according to sensitivity varied from 14 to 28 days, and, interestingly, no patient with positive culture had complications or presented signs of osteomyelitis during ambulatory follow-up. It is possible that complete debridement and partial resection of bone prominences until viable bone were important for these results, as well as a vascularized flap that provided oxygen and nutrients needed for the treatment of this condition. The presence of a family member or caregiver during treatment of pressure lesions is vital for success16. Therefore, this was another inclusion criteria included in the present study. It is critical for the patient to change position (dorsal to lateral, lying to seated) and this must be done very carefully with the aid of another person during the first four weeks of

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post-operatory. One of the three dehiscence lesions was observed on the seventh day of post-operatory, due to mechanical trauma caused directly by change of position. Therefore, during pre-operatory visit, it was reinforced the need of familial involvement or the constant presence of a caregiver. Indirectly, it was also observed if the patient came to pre-operatory consultation with the wound in good conditions (clean, correct dressing, regression borders) and if hygiene conditions were adequate. If positive, the patient was considered eligible for the protocol. In view of the growing number of non-operated pressure lesions and the logistic difficulty to admit and operate these patients, it was proposed this short hospitalization protocol to treat pressure lesions grade IV. The patient is prepared at ambulatory and selected if fulfilled the inclusion criteria. Three goals were anticipated: 1) Lowering of hospitalization time; 2) Lowering of post-operatory dehiscence and wound complications; 3) Obtaining a stable covering with lower recurrence. In view of the obtained results (3.6 days of hospitalization, 11.1% of minor dehiscence and absence of recurrence) it is possible to affirm that goals were met. Literature historical data are in accordance to these results. Sameem et al.20 in a systematic review of 55 published studies, observed with fasciocutaneous flaps 11.7% of complications (5.1% of flap necrosis), 6.9% of post-operatory infection and a medium of 11.2% of recurrence (13 to 31%). Regarding medium follow-up of 9.1 months, this time interval may be considered relatively short for an accurate analysis. It must be observed that these patients have reduced mobility and depend on familial members and transport to attend ambulatory visits. Therefore, many patients are lost for follow-up, when their wounds are healed. It is important to mention that time interval to observe recurrence is higher than the one here reported, around 12 to 24 months. We concluded that the brief hospitalization protocol was considered adequate for the resolution of pressure wounds, with low time of hospitalization and low level of surgical wound dehiscence.

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R E S U M O Objetivo: avaliar o protocolo de internação breve para tratamento de lesões por pressão, em vigência no Grupo de Feridas Complexas do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, com ênfase na seleção do paciente, no tempo de internação, na cobertura cutânea realizada, nas complicações e nas recidivas das lesões. Métodos: coorte retrospectiva de 20 pacientes consecutivos com 25 lesões por pressão Grau IV. Todos os pacientes foram preparados em ambulatório e foram internados para fechamento cirúrgico da lesão por pressão em cirurgia única. Resultados: no total foram confeccionados 27 retalhos para cobertura de 25 feridas abordadas. Foram verificados três casos (11,1%) de deiscências menores. Não foi observada recidiva no período de seguimento pós-operatório. Nenhum paciente foi reoperado e nenhum retalho sofreu necrose parcial ou total. O tempo de internação médio foi de 3,6 dias (dois a seis dias) e o seguimento foi de 9,1 meses, em média, oscilando entre dois e 18 meses. Todos os pacientes permaneceram com a lesão fechada e nenhum deles apresentou recidiva da lesão durante o seguimento. Conclusão: o protocolo de internação breve para resolução de lesões por pressão foi considerado adequado, com curto tempo de internação e baixos índices de deiscência de ferida cirúrgica. Descritores: Lesão por Pressão. Ferimentos e Lesões. Retalhos Cirúrgicos. Cirurgia Plástica.

REFERENCES 1.

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Milcheski DA, Ferreira MC, Nakamoto H, Tuma Jr P, Gemperli R. Tratamento cirúrgico de ferimentos descolantes nos membros inferiores - proposta de protocolo de atendimento. Rev Col Bras Cir. 2010;37(3):195-203. MC Ferreira. Complex Wounds. Clinics. 2006;61(6):571-8. Phillips T, Stanton B, Provan A, Lew R. A study of the impact of leg ulcers on quality of life: financial, social, and psychologic implications. J Am Acad Dermatol. 1994;31(1):49-53. Pokorny ME, Rose MA, Watkins F, Swanson M, Kirkpatrick MK, Wu Q. The relationship between pressure ulcer prevalence, body mass index, and braden scales and subscales: a further analysis. Adv Skin Wound Care. 2014;27(1):26-30. National Pressure Ulcer Advisory Panel. Pressure ulcer definition and stages [Internet]. Washington: NPUAP; 2007. [cited 2007 Apr 13]. Available from: http://www.npuap.org/ Alves P, Mota F, Ramos P, Vales L. Epidemiologia das úlceras de pressão: interpretar dados epidemiológicos como indicador de qualidade [Internet]. Berlin: ResearchGate; 2007. [cited 2007 Apr 25] Available from: https://www.researchgate. net/publication/257140360 Brito PA, de Vasconcelos Generoso S, Correia MI. Prevalence of pressure ulcers in hospitals in Brazil and association with nutritional status--a multicenter, cross-sectional study. Nutrition. 2013;29(4):646-9.

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Eslami V, Saadat S, Habibi Arejan R, Vaccaro AR, Ghodsi SM, Rahimi-Movaghar V. Factors associated with the development of pressure ulcers after spinal cord injury. Spinal Cord. 2012;50(12):899-903. Byrne DW, Salzberg CA. Major risk factors for pressure ulcers in the spinal cord disabled: a literature review. Spinal Cord. 1996;34(5):255-63. Costa MP, Sturtz G, Costa FPP, Ferreira MC, Barros Filho TEP. Epidemiologia e tratamento das úlceras de pressão: experiência de 77 casos. Acta Ortop Bras. 2005;13(3):124-33. Alvarez OM, Fernandez-Obregon A, Rogers RS, Bergamo L, Masso J, Black M. Chemical debridement of pressure ulcers: a prospective, randomized, comparative trial of collagenase and papain/urea formulations. Wounds. 2000;12(2):15-25. Quassem A, Humphrey LL, Forciea MA, Starkey M, Denberg TD. Treatment of pressure ulcers: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2015;162(5):370-9. Barreiro GC, Millan LS, Nakamoto H, Montag E, Tuma Jr PT, Ferreira MC. Reconstruções pelveperineais com uso de retalhos cutâneos baseados em vasos perfurantes: experiência clínica com 22 casos. Rev Bras Cir Plást. 2011;26(4):680-4. Yamamoto Y, Ohura T, Shintomi Y, Sugihara T, Nohira K, Igawa H. Superiority of the fasciocutaneous flap in reconstruction of sacral pressure sores. Ann Plast Surg. 1993;30(2):116-21. Sugino H, Hashimoto I, Tanaka Y, Ishida S, Abe Y, Nakanishi H. Relation between the serum albumin level and nutrition supply in patients with pressure

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ulcers: retrospective study in an acute care setting. J Med Invest. 2014;61(1-2):15-21. Thomas DR. Role of nutrition in the treatment and prevention of pressure ulcers. Nutr Clin Pract. 2014;29(4):466-72. Ricci JA, Bayer LR, Orgill DP. Evidence-based medicine: the evaluation and treatment of pressure injuries. Plast Reconstr Surg. 2017;139(1):275e-286e. Ubbink DT, BrĂślmann FE, Go PMNYH, Vermeulen H. Evidence-based care of acute wounds: a perspective. Adv Wound Care. 2015;4(5):286-94. Pineda C, Espinosa R, Pena A. Radiographic imaging in osteomyelitis: the role of plain radiography, computed tomography, ultrasonography, magnetic resonance imaging, and scintigraphy. Semin Plast Surg. 2009;23(2):80-9.

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20. Sameem M, Au M, Wood T, Farrokhyar F, Mahoney J. A systematic review of complication and recurrence rates of musculocutaneous, fasciocutaneous, and perforator-based flaps for treatment of pressure sores. Plast Reconstr Surg. 2012;130(1):67e-77e.

Received in: 18/07/2017 Accepted for publication: 23/08/2017 Conflict of interest: none. Source of funding: none. Mailing address: Dimas AndrĂŠ Milcheski E-mail: drdimasandre@gmail.com / dimas.milcheski@hc. fm.usp.br

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Original Article

DOI: 10.1590/0100-69912017006006

Deaths from abdominal trauma: analysis of 1888 forensic autopsies Óbitos por trauma abdominal: análise de 1888 autopsias médico-legais

POLYANNA HELENA COELHO BORDONI1; DANIELA MAGALHÃES MOREIRA DOS SANTOS2; JAÍSA SANTANA TEIXEIRA2; LEONARDO SANTOS BORDONI2-4. A B S T R A C T Objective: to evaluate the epidemiological profile of deaths due to abdominal trauma at the Forensic Medicine Institute of Belo Horizonte, MG - Brazil. Methods: we conducted a retrospective study of the reports of deaths due to abdominal trauma autopsied from 2006 to 2011. Results: we analyzed 1.888 necropsy reports related to abdominal trauma. Penetrating trauma was more common than blunt one and gunshot wounds were more prevalent than stab wounds. Most of the individuals were male, brown-skinned, single and occupationally active. The median age was 34 years. The abdominal organs most injured in the penetrating trauma were the liver and the intestines, and in blunt trauma, the liver and the spleen. Homicide was the most prevalent circumstance of death, followed by traffic accidents, and almost half of the cases were referred to the Forensic Medicine Institute by a health unit. The blood alcohol test was positive in a third of the necropsies where it was performed. Cocaine and marijuana were the most commonly found substances in toxicology studies. Conclusion: in this sample. there was a predominance of penetrating abdominal trauma in young, brown and single men, the liver being the most injured organ. Keywords: Autopsy. Forensic Medicine. Homicide. Abdominal Injuries.

INTRODUCTION

D

eaths from external causes represent the second leading cause of mortality in Brazil and the main cause when considering individuals under the age of 351. Due to the predominance in young and productive people, external causes are the main factors responsible for potential years of life lost in Brazil1,2. Central nervous system injuries account for about half of deaths from trauma, and blood losses by about one-third3. Hemorrhage is the most common cause of avoidable death in patients treated with trauma4. Injuries to abdominal structures are an important source of bleeding and are pose special medical interest, since they present great practical difficulties for adequate diagnosis and eventual therapeutic approach, especially when there are other associated lesions4,5. This is because almost half of the bleeding in the peritoneal cavity or retroperitoneum manifests itself with few or no symptoms.

In addition, the accuracy of abdominal physical examination is low and the level of consciousness produced by hemorrhages or by the association of abdominal trauma (AT) with traumatic brain injury and/or effects of central nervous system of previously consumed substances make the adequate clinical examination even more difficult6-8. Therefore, it is emphasized that the absence of abdominal pain or signs of peritoneal irritation on physical examination does not exclude the presence of abdominal organs injuries9. Even in cases of AT with death, there are no external lesions indicative of this type of trauma in up to 31% of cases10. These limitations together result in preventable deaths from undiagnosed abdominal injuries, even considering that the actual need for laparotomies due to closed abdominal trauma is around 5%6. AT can be classified basically into two types: penetrating (open) and blunt (closed)11. The penetrating is the one in which the entry of the aggressive agent

1 - Civil State Police of Minas Gerais, Coroner’s Office, Ribeirão das Neves, MG, Brazil. 2 - José Bonifácio Lafayette de Andrada Foundation, Faculty of Medicine, Barbacena, MG, Brazil. 3 - Civil State Police of Minas Gerais, Forensic Medicine Institute, Belo Horizonte, MG, Brazil. 4 - University of Ouro Preto, School of Medicine, Ouro Preto, MG, Brazil. Rev Col Bras Cir 2017; 44(6): 582-595


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into the peritoneal cavity occurs, in most cases a firearm projectile (gunshot) or a laminated object (stabbing) and it exerts its effects directly over the viscera. In this case, the organs most affected are the small intestine, colon and liver11. In blunt AT there is no penetration of the aggressive agent into the peritoneal cavity. The effects of the offending agent in this case are transmitted to the viscera through the abdominal wall, or by kickback and deceleration. The prevalence of abdominal viscera lesions in cases of blunt trauma is around 13%, the spleen and liver being the most damaged structures in this situation9. Considering the global epidemiology of AT, the majority of cases treated in hospital units are blunt trauma, but in regions with high homicide rates, such as large Brazilian cities and their metropolitan regions, penetrating trauma may be more frequent8,9,11,12. Around 75% of cases of blunt AT result from traffic accidents, with assaults accounting for 15% and falls for the rest9. The mean mortality rate of AF due to gunshot wounds, of around 7%, is higher than in cases of stabbing injuries and blunt trauma13. In recent years, in parallel with the increase in intentional and unintentional interpersonal violence in our country, the ATâ&#x20AC;&#x2122;s incidence has also increased2,11. In deaths due to external causes, or in cases that are suspected of being such, a legal medical necropsy is mandatory by our legislation14,15. In these situations, completing the death certificate is a responsibility of the coroner16. Data from necropsy medical-legal reports can provide important information in the epidemiological study of AT, since unlike the information available in the Mortality Information System (MIS) of the Ministry of Health, it contains a detailed description of the lesions found, as well as other important information on the context of death, such as data on the search for alcohol content and other substances consumed prior to death, such as illicit drugs. In addition, despite advances in imaging studies, necropsy remains the â&#x20AC;&#x153;gold standardâ&#x20AC;? for the confirmation of clinical and surgical diagnoses, including AT cases7. The ideal, therefore, for a complete epidemiological investigation on mortality by AT and for the other external causes is that medical-legal reports be a source of complementary information to the MIS, as recommended by the World Health Organization7,17.

Considering the importance of AT, as well as the deficiency of national information involving necroscopic studies with this cause of death, this research aimed to evaluate its epidemiological profile at the Belo Horizonte Forensic Medical Institute (IML-BH).

METHODS We conducted a retrospective study, in which were evaluated the reports of deaths from abdominal trauma necropsied in the IML-BH from January 1, 2006 to December 31, 2011. Located in the capital of the state of Minas Gerais, IML-BH is a government department linked to the Civil Police, being responsible for the medical investigation of all deaths due to external causes occurred in the capital of the state and in most of the municipalities of its Metropolitan Region (RMBH). Necroscopic forensic investigation of all deaths from violent causes is mandated by federal law in Brazil14. Belo Horizonte (BH) is the sixth most populous city in Brazil, with an estimated population of 2,513,451 inhabitants for the year 201618. Its metropolitan area is the third most populous in the country, with an estimated population of 5,829,921 inhabitants in the year 201518. The deaths analyzed in this study were those whose cause directly involved AT. We also included cases with trauma in other body regions, such as the head, limbs and thorax, as long as associated with AT in the mechanism of death. We excluded cases that presented technical problems in the completion of the reports, the duplicates, the cases whose types of trauma could not be precisely defined, and those in which the death was due to trauma occurring exclusively in other body regions other than the abdomen. We analyzed data on seasonality (year, month and day of the week), demographics (gender, age, marital status, occupational characteristics, skin color, and residence), deaths characteristics (circumstance, type of trauma, trauma mechanism, signs of medical care) and complementary tests performed (toxicological and blood alcoholic findings). Not all such variables were available in all reports. We considered that the deceased received medical care prior to death when they came from

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health facilities, when they were referred along with medical reports or when they showed signs of recent medical procedures such as vascular punctures, signs of orotracheal intubation, surgical wounds, placement of drains, among others. Even in cases that received medical attention, trauma indexes were not available. We performed statistical analyzes using the STATA software, version 9.2. We obtained frequency, position and central tendency measurements, and used the Chi-square and Fisher’s exact tests for comparison of qualitative variables and the Kruskal-Wallis test for comparison of quantitative ones, in order to evaluate possible associations. The level of significance was set at 0.05. The project was approved by the Ethics in Research Committee of the Hospital Foundation of the State of Minas Gerais, under the protocol number 23100813.2.0000.5119.

RESULTS We recovered 1888 reports of fatal victims of abdominal trauma (AT), corresponding to 5.2% of the total necropsies performed at IML-BH in the studied period (2006 to 2011). The underlying cause of death was hemorrhage and its direct complications in 1884 cases, and trauma-related infectious complications in four. Penetrating trauma was more common (78.76%) than blunt trauma (401 cases – Table 1). Of the penetrating trauma cases, gunshot wounds were more prevalent (89.28%) than stabbing wounds (159 cases). The highest proportion of necropsies occurred on Sundays (23.94%), in January (9.75%) and in 2007 (23.41%). The lowest number of autopsies took place on Fridays (165 cases), in the months of September (128) and in the year of 2010 (209). The majority of the individuals were male, brown, single, were 49 years old (90.79%), occupationally active, had completed high school as a minimum level of education required to practice their profession and did not reside in the city of Belo Horizonte (Table 1). We highlight the significantly higher proportion of necropsies in males, brown or black, single and residing in Belo Horizonte (BH) related to the deaths due to penetrating trauma compared with

blunt trauma (Table 1). There were also proportionally more men, unmarried and BH residents whose death was related to gunshots when compared with those whose death cause was stabbing (Table 2). The mean age found in the sample was 29.73±12.86 years, and the extremes of age were one and 90 years. The mean age of victims of penetrating trauma was significantly lower (27.87±10.62 years) than that of blunt trauma (36.64±17.32 years) (p<0.001). The mean age of gunshot victims was significantly lower (27.19±10.15 years) than that of stabbed individuals (33.70±12.66) (p<0.001). Homicide was the most prevalent death (78.55%). Health units sent most of such cases to the IML-BH (47.99%), although most necropsies did not undergo medical procedures prior to death (77.12%) (Figure 1). For blunt trauma, there was a significantly higher proportion of deaths due to traffic accidents (83.29%) and signs of receiving medical assistance prior to death (56.86%) compared to penetrating trauma (Figure 1). There were proportionately fewer individuals coming from residential addresses who died due to gunshots compared with those whose death was due to stabbing (Table 2). Among the homicide cases, we observed a higher percentage of males (92.51%). The data obtained with complementary exams performed in the AT victims, regarding alcohol and illicit drugs use, can be seen in table 3. There were proportionally more hepatic and splenic lesions in blunt traumas (315 and 170 cases, respectively) than in the penetrating trauma (1293 and 382 cases, respectively) (p=0.000 for both) (Figure 2). Although the most injured abdominal organ in penetrating trauma was the liver, there were predominantly more lesions in the intestines (853 cases), stomach (351 cases) and blood vessels (312 cases) of individuals victims of penetrating trauma when compared with blunt trauma (75, 17 and 31 cases, respectively) (p=0.000 for all variables). The kidneys were proportionally more affected in cases resulting from stab wounds (17 cases) compared with those related to gunshots (82 necropsies) (p=0.04). Intestinal lesions were more common in gunshot (709 cases) than in stabbing wounds (69 cases) (p=0.006). We observed concomitant lesions in more than one abdominal organ in some individuals.

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Table 1. Sociodemographic characteristics of abdominal trauma deaths according to trauma type (IML-BH, 2006 to 2011).

Gender a Male Female Age group a = 18 years 18-29 years 30-39 years 40-49 years 50-59 years 60-69 years = 70 years Unspecified Skin color a White Brown Black Unspecified Marital status a Single Married/stable Widow(er) Divorced or separated Unspecified Municipality of residence b Belo Horizonte Other Unspecified Occupationally active c Yes No Unspecified Education required for the exercise of professiona High-school College Undefined Home/Student/without occupation Unspecified

Penetrating trauma

Blunt trauma

N

%

N

%

N

%

1377 110

92.60 7.40

334 67

83.29 16.71

1711 177

90.63 9.37

160 802 329 114 43 19 8 12

10.76 53.93 22.13 7.67 2.89 1.28 0.54 0.81

28 138 81 62 44 19 24 5

6.98 34.41 20.20 15.46 10.97 4.74 5.99 1.25

188 940 410 176 87 38 32 17

9.96 49.79 21.72 9.32 4.61 2.01 1.69 0.90

346 964 171 6

23.27 64.83 11.50 0.40

170 207 24 0

42.39 51.62 5.99 0

516 1171 195 6

27.33 62.02 10.33 0.32

1220 176 8 38 45

82.04 11.84 0.54 2.55 3.03

242 115 16 18 10

60.35 28.68 3.99 4.49 2.49

1462 291 24 56 55

77.44 15.41 1.27 2.97 2.91

695 749 43 1122 319 46 1115 0 24 300 48

46.74 50.37 2.89 75.45 21.45 3.10 74.99 0 1.61 20.17 3.23

p= a 0.000 ; b 0.019 ; c 0.581. Rev Col Bras Cir 2017; 44(6): 582-595

162 229 10 297 91 13 300 11 11 60 19

40.4 57.11 2.49 74.07 22.69 3.24 74.82 2.74 2.74 14.96 4.74

Total

857 978 53 1419 410 59 1415 11 35 360 67

45.39 51.8 2.81 75.16 21.72 3.12 74.95 0.58 1.85 19.07 3.55


Bordoni Deaths from abdominal trauma: analysis of 1888 forensic autopsies

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Table 2. Comparison of penetrating abdominal trauma victims according to trauma mechanism (IML-BH, 2006 to 2011).

Gunshots * Gender a Male Female Marital status b Single Married/stable Widow(er) Divorced or separated Residence c Belo Horizonte Other Place of origin of the corpse d Residential address Health unit Public venus Business address Alcohol content Result a Positive Negative Toxicology Result a Positive Negative

Stabbings **

N

%

N

%

1244 80

93.96 6.04

129 30

81.13 18.87

1100 158 7 27

85.14 12.23 0.54 2.09

116 18 1 11

79.45 12.33 0.68 7.53

638 655

49.34 50.66

55 92

37.41 62.59

107 613 563 29

8.16 46.72 42.91 2.21

29 64 63 3

18.24 40.25 39.62 1.89

300 687

30.40 69.60

67 46

59.29 40.71

543 451

54.63 45.37

38 80

32.20 67.80

* Gunshots = Penetrating-blunt actions. ** Stabbings = Cutting/perforating-cutting actions. p= a 0.000 ; b 0.002; c 0.006 ; d 0.001.

Figure 1. Circumstances of deaths due to abdominal trauma and presence of medical care according to trauma type.

DC= Death circumstance. HMC= homicides. SUC= Suicides. TA= Traffic Accident. OA= Other accidents. NA= Data not available. OC= Origin of the corpse. RA= Residential address. HU= Health unit. PV= Public venue. BA= Business address. MC= Signs of medical care. MP= Signs of medical procedures. p= a 0.000, b 0.007.

We observed head injuries in 347 cases and thoracic organ injuries in 1503 individuals. Although the

lungs were the most affected extra-abdominal organs in all death mechanisms, we observed more injuries to the head and heart of the victims of penetrating trauma (346 and 722 cases, respectively) than in the victims of blunt trauma (49 102 cases, respectively) (p=0.000 for both) (Figure 3). Even with the presence of these associated lesions, they were not attributed by the coroners as exclusively responsible for the deaths. It is noteworthy that there were concomitant lesions in more than one body segment in some autopsies and that multiple organ lesions were observed in some individuals. For blunt trauma, in cases of both hepatic and splenic lesions, the limbsâ&#x20AC;&#x2122; fractures most frequently found were those of lower limbs, especially of the femur (49 cases/15.6% and 24 cases/14.2 %, respectively) and tibia/fibula (39 cases/12.4% and 18 cases/10.6%, respectively).

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The mean number of gunshot wounds to the abdomen was 1.33Âą1.28, with the median of one entry orifice, first quartile of one, and third quartile of two entry orifices. The highest number of entry lesions observed

in the same individual in the abdomen and/or chest were 15. The mean number of stab wounds was 2.76Âą4.41. It is noteworthy that gunshot and stabbing thorax entries were also responsible for abdominal organ lesions.

Table 3. Complementary exams in abdominal trauma deaths according to trauma type (IML-BH, 2006 to 2011).

Penetrating trauma

Total

Blunt trauma

N

%

N

%

N

%

Examined

1102

74.11

329

82.04

1431

75.79

Not examined

385

25.89

72

17.96

457

24.21

Positive

367

33.30

117

35.56

484

33.82

Negative

734

66.61

212

64.44

946

66.11

1

0.09

0

0

1

0.07

1115

74.98

186

46.38

1301

68.91

372

25.02

215

53.62

587

31.09

Positive

583

52.29

32

17.20

615

47.27

Negative

531

47.62

154

82.80

685

52.65

1

0.09

0

0

1

0.08

Alcohol content a

Alcohol content-Result b

Unspecified Toxicology

c

Examined Not examined Toxicology Result

a

Unspecified p= 0.,001 ; 0.453 ; 0.000. a

b

c

Figure 2. Abdominal organ injuries in fatal victims of abdominal trauma according to trauma mechanism (IML-BH, 2006-2011).

Figure 3. Thoracic organ injuries in fatal victims of abdominal trauma according to trauma mechanism (IML-BH, 2006-2011).

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DISCUSSION In our sample, penetrating trauma was much more frequent (78.8%) than blunt one. A study carried out with victims of AT submitted to exploratory laparotomy in the city of Florianรณpolis also found a majority (68.6%) of cases related to penetrating trauma19. However, these percentages vary when data from different cities and countries are observed. Retrospective studies of AT victims in the Portuguese city of Porto and in Kathmandu, Nepal, indicated that 85.3% and 82.5% were cases of blunt trauma, respectively20,21. The almost inverse percentages observed in these countries when compared with our sample reflect the different circumstances related to AT in each locality. Most cases of IML-BH autopsies were related to homicides (78.6%), especially cases of penetrating trauma, whereas in the Portuguese study, traffic accidents and falls were the most prevalent (76.1%), and in the Nepalese study, traffic accidents were the majority (87.5%), which are more related to blunt trauma20,21. In addition, our sample consisted only of fatal cases, while the Portuguese series also considered those who survived, and penetrating trauma displayed higher average mortality20. Considering all cases of penetrating trauma that receive medical attention, those due to stabbing are, in general, more frequent than cases related to gunshot wounds12. However, in the IML-BH sample, as well as in the data from the Florianรณpolis study19, it was observed that gunshot wounds were more frequent than stabbing wounds. The IML-BH greater proportion of gunshot wounds among the penetrating traumas is justified by the fact that abdominal injuries gunshots represent up to 90% of the mortality in penetrating AT13. By transferring increased kinetic energy to organs and tissues, abdominal trauma due to gunshots results in a mortality rate about eight times higher than that related to stabbing injuries22. Although in the cases of IML-BH the penetrating trauma due to gunshots represented a percentage greater than that found in the Florianรณpolis study (89.3% and 75.6%, respectively)19, that study also evaluated patients who survived the trauma (89.8% of those who underwent surgery), which may justify this dif-

ference19. The majority of individuals necropsied in IML-BH were male (90.3%), with a mean age of 34 years. In the study conducted in Porto, males were also more prevalent (74.2%) and the mean age was 42.6 years20. The higher male prevalence and the lower mean age observed in our sample are a reflection of the large proportion of homicides and penetrating trauma among the cases of IML-BH, situations in which male and younger victims are more commonly observed2. It should be noted that, in the Portuguese series, the most frequent trauma circumstance was traffic accident, which covers a larger age group and a larger female contingent2,20. In a case-control study conducted in the city of Curitiba, it was observed that in deaths due to blunt AT, males accounted for 77.4% of the cases and the mean age observed was 33.2 years23, results similar to those found in our sample if considered only cases of blunt AT (83.29% men and mean age 36.64 years). In a work involving homicide victims in Cape Town, 90.2% of the cases were men, a percentage practically identical to that of our sample24. In the period from 2002 to 2012, the number of homicides registered in Brazil increased from 49,695 to 56,337, an increase of 13.4%2. In Minas Gerais, homicides increased by 7.1% in the same period2. For the year 2012, Belo Horizonte had a total homicide rate of 40.6 per 100 thousand inhabitants, but when considering only homicides in individuals under 29 years, the rate more than doubles (91.9/100 thousand)2. The relationship between AT and male gender, especially in cases of gunshot homicides, is due to men being more involved in criminal use of firearms (widely available in our country), in addition to consuming proportionally more alcohol and illicit drugs than women, factors that increase aggressiveness and the adoption of violence-risky behaviors2,21. In 2012, the national rate of 54.3 homicides per 100,000 male residents was about ten times higher than the female rate (4.8/100 thousand)2. It is noteworthy that, while women accounted for only 6% of the gunshot victims in our sample, 18.9% were stabbing victims, which may suggest the passionality of assaults against women, which occur frequently in the domestic sphere, where knives are easily accessible to the aggres-

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sor25. While almost half of all homicides occur in public spaces, less than a third of female homicides occur in such locations, the victim’s home being the site of 27.1% of female homicides25. Such data together may also justify the larger proportion of stabbed individuals coming from their home addresses found in our sample compared with those whose death was related to gunshots. Only 1.16% of the cases of homicide with AT autopsied in the IML-BH involved blunt trauma. A South African study of victims of blunt trauma homicides showed that, although 20% had some type of abdominal injury, in only 7% there were no significant associated cranial lesions24. Tunisian cases with homicide data from 2005 to 2014 indicated that blunt trauma was the second most common death mechanism (24.8%)26. Most individuals (90.79%) were up to 49 years of age (about 50% in the age group 18-29 years), which may be related to most individuals being single. The mean age of victims of penetrating trauma in homicides, 27.87 years, was significantly lower than that of injuries resulting from blunt trauma in traffic accidents, 36.64 years, which agrees with the national statistics on mortality from external causes. When considering the deaths of individuals under 29 in Brazil, in 2012, 71.1% were due to external causes, with 38.7% of homicides2. Most of the necropsied had brown skin, both in cases of penetrating trauma (64.8%) and in blunt traumas (51.6%). A study conducted in the city of Salvador with deaths from external causes from 1998 to 2003 indicated that men with brown skin lose more potential years of life due to violence than the black and white population27. Such differences observed in potential years of life lost per 100,000 inhabitants among different skin color groups remained even after age standardization, and brown and black men, in that order, died earlier due to all types of external causes27. Whites tend to have a better average schooling rate than browns and blacks, a better socioeconomic level, better access to health promotion measures and less exposure to violence27. Weekends concentrate most of the cases of external deaths, especially homicides, in several studies24,28-30. In our sample, where the death circums-

tance was predominantly homicide, almost a quarter (23.9%) of autopsies occurred on Sundays. Epidemiological data on homicides in the state of São Paulo, in Cape Town, South Africa, and in the city of Ilhéus, Bahia, indicated that Sundays also concentrated the highest proportional number of cases (20%, 23.7% and 32%, respectively). This corroborates that the weekend is the period of greatest exposure to risk factors for violence, such as the consumption of alcohol and illicit drugs, as well as the permanence in environments conducive to interpersonal conflicts28. The same reasoning applies to those periods with longer and hotter days, especially January, which concentrated 9.8% of IML-BH cases. At the Getúlio Vargas State Hospital, in the city of Rio de Janeiro (HGV-RJ), with 1688 patients operated on with blunt AT, the spleen was the most damaged abdominal organ, followed by the liver, intestines (small and large), bladder and the kidneys11. A study in Santa Catarina State patients submitted to exploratory laparotomy indicated splenic lesions twice as frequent as hepatic ones in blunt trauma19. In the IML-BH data, the liver was the most affected viscera in blunt AT, with the spleen in second, followed by the intestines and large abdominal vessels. Similarly, another necroscopic (Nepalese) study also indicated a higher percentage of hepatic lesions (57.5%) than spleen ones (37.5%)10. Hepatic lesions produce potentially larger hemorrhages than splenic injuries, and as our casuistry involved only those who died, the considerably higher percentage of liver lesions is explained. A case-control study with victims of blunt AT who received medical care showed that, for most of deaths preceded by hemodynamic instability, there were lesions of massive abdominal viscera23. The retrospective study with polytrauma patients who presented severe traumatic brain injury demonstrated that the liver was the most affected abdominal viscus in cases with associated AT and signaled that hemodynamic instability at hospital admission indicated a six-fold increased risk for the presence of abdominal viscera lesions compared with patients who were hemodynamically stable6. Hemorrhage, with its direct complications, was responsible for almost all deaths in our sample (1884 cases).

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In cases of blunt AT necropsied in the IML-BH, femoral fractures were observed in 15.6% of individuals with hepatic lesions and in 14.2% of cases with splenic lesions. Femur fracture was the bone lesion most frequently associated with abdominal viscera lesions in our data, which is widely corroborated by the literature. A systematic review of 10,757 patients with blunt trauma indicated that the concomitant presence of femoral fracture increased the relative risk of visceral abdominal injury by 2.9 times9. The risk of abdominal visceral injury increased 58-fold when there were surgical orthopedic lesions in polytraumatized patients with cranio-encephalic trauma6. The proportion of lesions in large abdominal (arterial and venous) vessels observed in our sample, of 8%, was higher than that found in the Rio de Janeiro series in cases operated due to closed AT (0.7%)11, but the severity of volume loss in necropsied cases explains its greater prevalence in our data. The second most common circumstance of death in the IML-BH data were traffic accidents, with all AT deaths in this group due to blunt trauma. The intestines, especially the small one, are the most damaged abdominal viscera in blunt AT, being affected in up to 3% of the cases31,32. A prospective multicenter American study has indicated that victims of traffic accidents are 1.5 times more likely to present abdominal hollow viscera lesions than in other blunt trauma mechanisms32. In addition, the mortality rate ranges from 15% for small intestine lesions to around 19% for rectal lesions33. These data, together, corroborate what we observed, a high percentage of intestinal lesions in blunt AT (19%), which reflects large energy transfers in traffic accidents in fatal cases. For cases of blunt trauma with isolated abdominal hollow viscera lesions, the Paranรก case-control study indicated that this is a good prognostic factor, even in lesions that require surgical intervention23. That is, usually in fatal cases of blunt AT, injuries other than those of hollow viscera are responsible for death. We observed this in our sample, where lesions of intestines in blunt AT were generally associated with other visceral lesions, since in none of these cases the cause of death was exclusively determined by intestinal lesions. Gastric lesions in blunt AT are observed in

up to 1.7% of cases, a low percentage explained by the relatively protected anatomical position of this organ33,34. Although relatively rare, they present high mortality, varying from 28% to 66%31-33. This justifies the higher percentage (4%) observed in the IML-BH data, since only fatal cases, naturally more severe, were studied. Because it presents a protected position, a greater transfer of energy is necessary to produce a gastric lesion, and in about 95% of the cases, there are other associated lesions, such as of the spleen and lungs33-35. Like with intestinal lesions, there were no deaths exclusively due to gastric lesions in our data. The most damaged organs in cases of penetrating AT necropsied in IML-BH were the liver, followed by the intestines, both in gunshot and stabbing victims. Although there are regional variations, the reverse is epidemiologically observed, with intestines more damaged than the liver in this type of trauma12,13,19. A HGV-RJ series with 4478 patients operated on due to penetrating AT indicated that the intestines (duodenum, jejunum, ileum and colon) were the most commonly affected abdominal organs, followed by the liver, stomach and kidneys11. The same was observed in a Florianรณpolis study19. Liver lesions by penetrating AT show higher mortality rates than intestinal lesions13,36, reaching 22% in gunshot wound cases and 8% in stabbing ones36, which explains their high prevalence in IML-BH penetrating necropsies. Although the liver was the most commonly injured abdominal organ in penetrating AT in our sample, there were predominantly more lesions in the intestines, stomach and large abdominal vessels of individuals who were victims of penetrating trauma compared with victims of blunt trauma. It is noteworthy that isolated hepatic lesions due to gunshots are not common, these being usually associated with other lesions, particularly the right lung, diaphragm, right kidney and small intestine37. In our sample, 81% of the victims had lung injuries associated with the abdominal trauma. Abdominal vascular injuries due to penetrating trauma, especially those located in the upper portion of the abdomen, present a high mortality rate because they produce massive hemorrhage and present a high incidence of associated lesions38. The mortality rates of abdominal vascular injuries can reach 53%

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in cases of shooting and 32% in cases of stabbing36. The HGV-RJ data showed a low percentage of lesions of large abdominal vessels in open trauma, with only 2.5% of cases presenting lesions of the inferior vena cava and lower percentages with lesions of other important abdominal vessels 11. In the Florianópolis study with patients operated on due to penetrating AT, vascular lesions were observed in 5.4% of cases 19. We should emphasize that the series from Rio and Florianópolis involved both patients who died and those who recovered from the surgical procedures. In our sample, we observed lesions of large abdominal arterial or venous vessels in larger proportions (18% of the victims of gunshots and 23% of the victims of stabbing), since the main immediate cause of death in AT is blood loss. The mean number of gunshot entry wounds that caused lesions to abdominal viscera was 1.3 and the mean of stab wounds was 2.8. Multiple stabbing wounds are found in up to one-third of patients receiving medical care for this type of trauma 12. Since the transfer of kinetic energy to the tissues is much greater in the gunshot injuries 13, the smaller number of perforations is sufficient to cause serious lesions causing death. One of the consequences of this is that the kidneys, which are retroperitoneal and, therefore, deeper structures, were proportionally more injured in cases resulting from stabbing compared with those related to gunshots. The proportion of 33.8% positivity in the studied blood alcohol levels in our sample was similar to that found in a retrospective study that used data from all violent deaths occurred in the state of São Paulo in 2006, of 36.9%39. Such data may indicate common cultural traits related to the consumption of this substance among different units of the Brazilian Federation. The mean blood alcohol content in the study from São Paulo, 18dg/L, was higher than that found in our sample, 15.3dg/L, although it involved a larger geographical area and all causes of external deaths 39. Another study, based on data from 2042 homicide victims in the city of São Paulo, found a positive reaction to ethyl alcohol in 43% of cases, with an average of 15.5dg/L40, practically the same average value of our data. The majority of cases of blunt

AT of the IML-BH presented an average higher alcohol content, of 18.54dg/L. Knowing that such cases were related to traffic accidents, we highlight the probable association between alcohol consumption and this circumstance of death, already widely described in the literature 41. The IML-BH data also showed proportionally more positive cases of alcohol consumption, and with higher averages, 20.4dg/L, in stabbing-related deaths than in gunshot victims, 12.17dg/L, which was also observed in the study with homicide victims in the city of São Paulo 40. Interpersonal assaults with the use of knives generally involve more passion than the violence related to firearms and, in this context, is related to higher means of alcoholism positivity 40. Alcohol is the most commonly found substance in forensic toxicology analyzes and is an important risk factor for violent deaths, being directly involved in up to 50% of such deaths 39,41. Although alcoholic drunkenness is a syndrome of essentially clinical diagnosis, and non-laboratory, with a blood alcohol content of 15dg/L, most people will present important neurological changes, such as emotional instability, loss of critical thinking, variable memory deficits, sleepiness and motor deficits, among others 41. These effects put the individual at risk for violent behaviors or for negligence with situations of potential risk, such as accidents and assaults 39,41. The drugs most commonly found in IML-BH toxicological investigations were cocaine and marijuana, the most commonly used illicit drugs in Brazil 42,43. Similarly, in the study carried out with data from the MIS and IML-BH, which evaluated cases of homicides occurred in Belo Horizonte from 2000 to 2009, it was observed that cocaine was the most common illicit drug 43. A meta-analysis of 28,868 toxicological investigations of 30,482 homicide victims in five countries found that cocaine was the most common illicit drug, with 11% of cases, followed by marijuana, with 6%, cocaine being related to an increased risk of death by gunshot wounds 44. Similarly, in the IML-BH data, there were proportionally more positive results in the toxicology exams of individuals who died due to gunshots compared with those whose death was caused by stabbing wounds. The percentage of cocaine -positive cases in our sample, 40.9%, was higher than

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that found in homicide victims in the American city of New York, 31%45, almost double the percentage found in homicide victims in the state, 20.9%46, and almost quadrupled that found in the meta-analysis with data from five different countries44. Although we studied a more specific group of individuals, we highlight the relation between cocaine and violent death, be it in cases of homicide or in cases of accidents or suicides46. The meeting of 20 individuals with simultaneously positive toxicological examination for cocaine and marijuana reaffirms the association between these two drugs and violent deaths46. The consumption of illicit drugs is an important risk factor for deaths due to external causes, not only due to its effects on the central nervous system and consequent behavioral changes, but also to exposing the user to situations of violence related to the acquisition and commercialization of the substance43. Although there is evidence that Brazilian and Ameri-

can consumption of marijuana is greater than that of cocaine, its stimulating effects on the central nervous system, different from the predominantly inhibitory effects of marijuana, predispose the user to situations of violence43,46,47. As important limitations of this study, we should highlight that the information was collected from secondary sources and that the information on the detailed history of the deaths’ circumstances was not available in the reports evaluated. Moreover, the extrapolation of the conclusions should be considered with care, since the data were obtained from a specific geographic region. There are administrative and technical peculiarities involving the operation of different Legal Medical Institutes in the different Brazilian states and in other countries, which influence which cases are directed to necropsy, how necropsies are performed and how reports are made.

R E S U M O Objetivo: avaliar o perfil epidemiológico dos óbitos por trauma abdominal no Instituto Médico Legal de Belo Horizonte. Métodos: estudo retrospectivo dos laudos de óbitos relacionados a trauma abdominal necropsiados no período de 2006 a 2011. Resultados: foram analisados 1888 laudos necroscópicos de trauma abdominal. O trauma penetrante foi mais comum que o contuso, e o decorrente de projéteis de arma de fogo mais prevalente que o relacionado a armas brancas. A maioria dos indivíduos era do sexo masculino, morena, solteira e ativa do ponto de vista ocupacional. A média etária foi de 34 anos. O homicídio foi a circunstância do óbito mais prevalente, seguido dos acidentes de trânsito, e quase a metade dos casos foi recebida no Instituto Médico Legal proveniente de uma unidade saúde. Os órgãos abdominais mais lesados no trauma penetrante foram o fígado e os intestinos, e no trauma contuso foram o fígado e o baço. A pesquisa de alcoolemia foi positiva em um terço das necropsias onde foi realizada. Cocaína e maconha foram as substâncias mais encontradas nos exames toxicológicos. Conclusão: nesta amostra houve predominância do trauma abdominal penetrante, em homens jovens, morenos e solteiros, sendo o fígado o órgão mais lesado. Descritores: Autopsia. Medicina Legal. Homicídio. Traumatismos Abdominais.

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Processo Penal. D.O.U de 13 de outubro de 1941 (retificado em 24 de outubro de 1941). Acesso em 2017 Mar 26. Disponível em: http://www. planalto.gov.br/ccivil_03/decreto-lei/Del3689. htm. Conselho Federal de Medicina. Resolução número 1.779 de 05 de Dezembro de 2005 - Regulamenta a responsabilidade médica no fornecimento da Declaração de Óbito. D.O.U de 05 de dezembro de 2005; seção 1, p.121. Acesso em 2017 Mar 26. Disponível em: http://www.portalmedico.org. br/resolucoes/cfm/2005/1779_2005.htm. Holder Y, Peden M, Krug E, Lund J, Gururaj G, Kobusingye O, editors. Injury surveillance guidelines. Geneva: World Health Organization; 2001. [cited 2017 May 5]. Available from: http://apps.who.int/ iris/bitstream/10665/42451/1/9241591331.pdf Brasil. IBGE. Estimativas da população residente nos municípios brasileiros. [citado 2016 Jun 6]. Disponível em: http://www.ibge.gov.br Kruel NF, Oliveira VL, Oliveira VL, Honorato RD, Pinatti BD, Leão FR. Perfil epidemiológico de trauma abdominal submetido à laparotomia exploradora. ABCD Arq Bras Cir Dig. 2007;20(2):106-10. Leite S, Taveira-Gomes A, Sousa H. Lesão visceral em trauma abdominal: um estudo retrospetivo. Acta Med Port. 2013;26(6):725-30. Subedi N, Yadav BN, Jha S, Paudel IS, Regmi R. A profile of abdominal and pelvic injuries in medico-legal autopsy. J Forensic Leg Med. 2013;20(6):792-6. Zafar SN, Rushing A, Haut ER, Kisat MT, Villegas CV, Chi A, et al. Outcome of selective nonoperative management of penetrating abdominal injuries from the North American National Trauma Database. Br J Surg. 2012;99 Suppl 1:155S-64S. Pimentel SK, Sawczyn GV, Mazepa MM, Rosa FGG, Nars A, Collaço IA. Fatores de risco para óbito no trauma abdominal fechado com abordagem cirúrgica. Rev Col Bras Cir. 2015;42(4):259-64. Clark C, Mole CG, Heyns M. Patterns of blunt force homicide in the West Metropole of the City of Cape Town, South Africa. S Afr J Sci. 2017;113(5/6):1-6. Waiselfisz JJ. Mapa da violência 2015: homicídios

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35. Nance ML, Peden GW, Shapiro MB, Kauder DR, Rotondo MF, Schwab CW. Solid viscus injury predicts major hollow viscus injury in blunt abdominal trauma. J Trauma.1997;43(4):618-22. 36. Wilson RF, Walt AJ. Injuries do the liver and biliary tract. In: Wilson RF, Walt AJ. Management of trauma: pitfalls and practice. 2nd ed. Baltimore: Lippincott Williams & Wilkins; 1996. p. 449-72. 37. Starling SV, Azevedo CI, Santana AV, Rodrigues BL, Drumond DAF. Lesão hepática isolada por arma de fogo: é possível realizar tratamento não operatório? Rev Col Bras Cir. 2015;42(4):238-43. 38. Fraga GP, Mantovani M, Hirano ES, Leal RF. Trauma da Veia Porta. Rev Col Bras Cir. 2003;30(1):43-50. 39. Sinagawa DM, Godoy CD, Ponce JC, Andreuccetti G, Carvalho DG, Muñoz DR, Leyton V. Uso de álcool por vítimas de morte violenta no Estado de São Paulo. Saúde, Ética & Justiça. 2008;13(2):6571. 40. Andreuccetti G, Carvalho HB, Ponce JC, Carvalho DG, Kahn T, Muñoz DR, et al. Alcohol consumption in homicide victims in the city of São Paulo. Addiction. 2009;104(12):1998-2006. 41. Spitz WU. Forensic aspects of alcohol. In: Spitz WU, Spitz DJ. Spitz and Fisher’s medicolegal investigation of death: guidelines for the application of pathology to crime investigation. 4th ed. Springfield: Charles C Thomas; 2006. p. 1218-29. 42. Minayo MCS, Deslandes SF. A complexidade das relações entre drogas, álcool e violência. Cad Saúde Públ. 1998;14(1):35-42. 43. Drumond EF, Souza HNF, Hang-Costa TA. Homicídios, álcool e drogas em Belo Horizonte, Minas Gerais, Brasil, 2000-2009. Epidemiol Serv Saúde. 2015;24(4):607-13. 44. Kuhns JB, Wilson DB, Maguire ER, Ainsworth SA, Clodfelter TA. A meta-analysis of marijuana, cocaine and opiate toxicology study findings among homicide victims. Addiction. 2009;104(7):1122-31. 45. Tardiff K, Marzuk PM, Leon AC, Hirsch CS, Stajic M, Portera L, et al. Homicide in New York City. Cocaine use and firearms. JAMA. 1994;272(1):436.

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46. Sheehan CM, Rogers RG, Williams GW 4th, Boardman JD. Gender differences in the presence of drugs in violent deaths. Addiction. 2013;108(3): 547-55. Erratum in: Addiction. 2013;108(6):1176. 47. Santos ZMSA, Farias FLR, Vieira LJVS, Nascimento SCO, Albuquerque VLM. Agressão por arma branca e arma de fogo interligada ao consumo de drogas. Texto Contexto Enferm. 2004;13(2):22632.

Recebido em: 30/06/2017 Aceito para publicação em: 27/07/2017 Conflito de interesse: nenhum. Fonte de financiamento: nenhuma. Endereço para correspondência: Leonardo Santos Bordoni E-mail: leonardosantosbordoni@gmail.com / polyannabordoni@gmail.com

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Original Article

DOI: 10.1590/0100-69912017006009

Comparison between isolated serial clinical examination and computed tomography for stab wounds in the anterior abdominal wall Comparação entre exame clínico seriado isolado e tomografia computadorizada nos ferimentos por arma branca na parede anterior do abdome RICARDO BREIGEIRON, TCBC-RS1,2; TIAGO CATALDO BREITENBACH1; LUCAS ADALBERTO GERALDI ZANINI1; CARLOS OTAVIO CORSO, TCBC-RS1,2, A B S T R A C T Objective: to compare abdominal computer tomography (CT) with isolated serial clinical exam (SCE) in the management of anterior abdominal stab wounds. Methods: randomized prospective study performed at Hospital de Pronto Socorro de Porto Alegre involving patients with anterior abdominal stab wounds without indication of immediate laparotomy; patients were divided in two groups: CT group and SCE group, In the SCE group, patients were followed up with serial clinical exam every 6 hours, Patients of CT group were submitted to abdominal computer tomography after initial evaluation. Results: 66 patients were studied and 33 were included in each group, Of total, six were submitted to surgery, three of each group, In the SCE group, patients submitted to surgery in media waited 12 hours from arrival to diagnosis without any non-therapeutic surgeries, The remaining 30 patients of this group were discharged from hospital after 24 hours of observation, In the CT group, three patients showed alteration at CT and were submitted to laparotomy, one non-therapeutic, The others were discharged from hospital after 24 hours of observation, Abdominal computer tomography had a positive predictive value (PPV) of 67% and negative predictive value (NPV) of 100%, with 96% of accuracy, Isolated serial clinical exam showed PPV and NPV of 100% and 100% of accuracy. Conclusion: selective management of anterior abdominal stabs is safe, when a rigorous selection of patients is observed, Isolated serial clinical exam may be performed without computer tomography, without increase of hospitalization time or morbidity, reducing costs, exposure to radiation, mortality and morbidity and non-therapeutic laparotomies. Keywords: Tomography, Emission-Computed. Wounds, Stab. Abdomen. Physical Examination.

INTRODUCTION

A

bdominal penetrating wounds are frequently attended at trauma centers, in special due to urban violence and suicide attempts1. They include stab wounds, and the abdomen is one of the most usual inflicted location2. Management of patients with anterior abdominal stab wounds is controversial, particularly of those without any signs that could justify immediate surgery (peritonitis, hemodynamic instability). In the present, selective management is recommended by several scientific publications and it is adopted by most trauma centers. The safest protocol to improve diagnostic exams efficiency, minimize costs and reduce collateral effects is still debated in literature3-11. The

goal, in special of diagnosis, is to recognize if there is abdominal penetration, and, if positive, if there is any lesion of an intra-abdominal structure. Diagnostic peritoneal wash-out, FAST, video-laparoscopy and computer tomography (CT) may be used for diagnostic management of these patients, with different sensitivities and specificities9,12,13. Abdominal CT, frequently used in trauma, have good results according to literature, and is part of initial exams of several protocols. However, CT has risks related to contrast use and radiation exposure, with direct and indirect costs14. Another possible initial management is serial clinical examination (SCE) without image exams. Some authors believe that isolated SCE may increase diagnosis of unnoticed lesions that could lead to complications. Current literature has shown that

1 - Hospital de Pronto Socorro de Porto Alegre, Serviço de Cirurgia do Trauma, Porto Alegre, RS, Brasil. 2. Universidade Federal do Rio Grande do Sul, Programa de Pós-Graduação em Medicina: Ciências Cirúrgicas, Porto Alegre, RS, Brasil. Rev Col Bras Cir 2017; 44(6): 596-602


Breigeiron Comparison between isolated serial clinical examination and computed tomography for stab wounds in the anterior abdominal wall

abdominal CT and SCE among all have the highest reliability and performance5. The objective of the present study was to compare these two diagnostic methods in the management of anterior abdominal stab wounds.

METHODS Prospective randomized clinical study of a simple random sample of patients attended at Emergency Room of Hospital de Porto Alegre, a referral trauma center of the State of Rio Grande do Sul, Brazil. Supervision and academic support were provided by the Surgical Medical Post-Graduation Department of Federal University of Rio Grande do Sul. Patients were selected from July 2011 to February 2015. The study was approved by the Ethical Committee of Municipal Health Secretary of Porto Alegre, under the number 001.026184.11.7, in accordance to resolutions CNS 196/96, 251/97 and 292/99 of the National Health Council/National Ethics Research Council/ National Health Surveillance Agency. In order for the patients to be included in the study, they should have been subjected to only one anterior abdominal stab wound, with hemodynamic stability and no diffuse peritoneal irritation. They were also selected if presented only pain at the site of stab and proximities. They should had 16 to 80 years old. Obligatorily Glasgow Coma Scale should be â&#x2030;Ľ12, and patients with clinical signs of alcohol or drug abuse were also selected if met the coma Glasgow scale criteria. Patients could present stabs in other locations, such as thorax, extremities, head, neck or perineum, as long as such wounds did not need immediate surgery. During observation time, if there was need of surgery of other body locals, patients were excluded. Patients with previous abdominal surgery were not included in the study; patients with unquestionable need of immediate surgery, that did not meet the inclusion criteria or patients with evisceration were also excluded. For topography analysis of anterior abdominal wall, the region was divided in four quadrants. Anterior abdominal wall was superiorly delimited by the inferior border of bilateral last costal arch, inferiorly by inguinal ligaments and pubic symphysis and laterally by right and left medium axillary line. Wound exploration included

597

local antisepsis, placement of sterile surgical dressings, local anesthesia and digital exploration or with the aid of anatomic forceps. Abdominal cavity was considered open when it was observed violation of aponeurosis. In dubious cases (abdominal penetration) the patient was included, since in these cases it is important to observe and follow-up the patient. After met inclusion criteria, patients were randomized by simple draw in two groups. The first group (CT group) was submitted to abdominal computer tomography with the use of intravenous contrast. In the presence of free liquid without lesion of major viscera, pneumoperitoneum, intestinal wall thickening, discontinuity of abdominal wall, retro-pneumoperitoneum or mesenteric or retroperitoneal hematoma, the patient was referred to surgery (exploratory laparotomy). Otherwise, patients were observed for 24 hours, without intake of any oral food and clinically examined every six hours. The other group (SCE) was clinically observed without any further image or laboratorial exams. Every six hours, the patient was physically examined (particularly the abdomen), including mucosa and vital signs, preferably by the same observer. If, in any group, any patient during follow up observation time presented any alteration of physical exam or vital signs (such as peritoneal irritation, hemodynamic instability, tachycardia, tachypnea or axillary temperature =37.8oC) the medical team was authorized to operate or to perform CT or laboratorial exams, in order to elucidate the diagnosis. All patients were ambulatorily attended 15 days after discharge from hospital. CTs were performed by a helical 64-channel tomography; routine exam included a pre-contrast phase, and, following contrast injection, arterial, venous and late phases; slices were standardized as of 2mm. All CT scans were analyzed and validated by a radiologist and revised by the on-call surgical team, including one surgeon and two residents of the Trauma and General Surgeries Departments. Patient was follow-up during hospitalization by the same team of residents, with supervision of the attending surgeon, or , eventually, by the next day on-call surgeon. All patients or relatives before randomization were informed and signed an informed consent term. In case of refusal, patient was not included and received

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treatment according to the recommendations of the attending surgeon. Quantitative variables used to compare both groups (in order to verify homogeneity) included: age, hospitalization time, Glasgow coma scale, RTS (Revised Trauma Score), and TRISS (Trauma and Injury Severity Score). Categorical variables (with the same objective) included: sex, abdominal lesion topography, presence of extra-abdominal lesions, comorbidities and laparotomy performed. For categorical variables analysis, it was used the chi-square test or Fisher exact test. For quantitative variables analysis, it was used the Student t test for those with normal distribution (according to Kolmogorc-Smirnov test) and Mann-Whitney-Wilcoxon for those when it was not possible to assume a normal distribution. P=0.05 was considered statistical significant. Sensitivity and specificity were determined by Fisher exact test, using the presence of lesion during surgical laparotomy as the gold standard parameter.

RESULTS During the studied period, 547 patients with penetrating abdominal wounds were studied, 246 (45%) with stab wounds. 66 patients met the inclusion criteria and were included in the study, 33 at each group. Of total, 87.9% (88) were male. Medium age was 33.2 years (SD=13.0). Medium hospitalization time was 3.4 days (SD=7.8) and median was 1.0 day (1.0/2.0). Topography analysis of anterior abdominal wall divided the region in four quadrants. There were 20 wounds in superior right quadrant, 18 wounds in superior left quadrant, seven wounds in right inferior quadrant and 21 wounds in left inferior quadrant. In total, 50 patients (75.8%) presented only lesions at abdomen, without any associated lesion in other topography. Most common lesions were at extremities (7 patients) and thorax (7 patients) (10.6%). Glasgow coma scale score was in media 15 (SD=0.3). Revised Trauma Score (RTS) had the highest value in all sample and Trauma and Injury Severity Score medium was 0.99 (SD=0.002). Table 1 shows the demographic and clinical characteristics, proving homogeneity of groups. Of the total, six patients (9.1%) were submitted to laparotomy, three of each group. Table 2 shows

the lesions found during laparotomy. One patient of SCE group submitted to laparotomy developed a peritoneal cavity abscess. Patients submitted to surgery of CT group included one with peritonitis and evisceration as intra-abdominal complications. All complications are described at table 3. In the patients submitted to surgery of SCE group, medium time from initial consultation to diagnosis of the need of surgery was 12 hours (SD=6.0). In this group there were no non-therapeutic laparotomies. The 30 patients of this group that were not submitted to surgery were discharged from hospital after a minimum period of 24 hours of observation, and had no complications. In the CT group, three patients showed alterations at CT and were submitted to laparotomy. In this group, there was one non-therapeutic laparotomy (CT scan showed free liquid at abdominal cavity without lesion of major viscera). The 30 patients of this group that were not operated were discharged from hospital after a minimum period of observation of 24 hours, without complications. CT sensitivity as initial diagnostic method was 100%; specificity was 96.7%, positive predictive value was 67% and negative predictive value was 100%, accuracy was 96%. SCE showed sensitivity and specificity of 100%, 100% of accuracy (Table 4).

DISCUSSION Non-surgical selective management of penetrating abdominal stab wounds has changed over the last years. A classical paper published by Shaftan15, in 1960, proposed a new era of management of abdominal trauma. Some publications show that indication of systematic laparotomy for patients with penetrating stab abdominal wounds can lead to a non-therapeutic laparotomy rate of 71% to 82%16,17. Literature affirms that selective management is adequate and save, as long as rigid criteria of selection of patients is observed and performed at a referral trauma center18. Many surgeons in several countries adopt this treatment19,20 and it is performed at Emergency Room of Hospital de Porto Alegre for many years. However, definition of the best way to treat anterior abdominal wall stab wounds, particularly at first moment, is still not well stablished,

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Table 1. Clinical and demographic characteristics.

Age (years)a Gender (%) Male Female Hospitalization (days)b Glasgow (admission)a RTSa TRISSa Topography of lesion at abdominal wall (%) RSQ LSQ RIQ LEQ Extra-abdominal lesion (%) Comorbidities (%) Laparotomy (%)

SCE group (n=33) 34.7 (12.7)

CT group (n=33) 31.6 (13.4)

28 (84.8) 5 (15.2) 1.0 (1.0/2.0) 15 (0.2) 7.6 (0.0) 99 (0.0)

30 (90.9) 3 (9.1) 1.0 (1.0/2.0) 15 (0.3) 7.6 (0.0) 99 (0.0)

11 (33.3) 7 (21.2) 5 (15.2) 10 (30.3) 6 (18.2) 17 (51.5) 3 (9.1)

9 (27.3) 11 (33.3) 2 (6.1) 11 (33.3) 10 (30.3) 17 (51.5) 3 (9.1)

Pc

0.243 0.451 0.915 0.957 1.000 1.000 0.490

0.251 1.000 1.000

SCE: serial clinical exam, CT: computer tomography, aMedium (Standard Deviation); bMedian (interval 25/75), c Chi-square test or Fisher Exact test for categorical variables; t Student test and Mann-Whitney-Wilcoxon test for quantitative variables; RTS= Revised Trauma Score; TRISS= Trauma and Injury Severity Score; RSQ= right superior quadrant; LSQ= left superior quadrant; RIQ= right inferior quadrant; LIQ= left inferior quadrant. Table 2. Lesions found at laparotomies.

Lesions (organs) Duodenum Liver Small intestine Gallbladder

SCE group 1 2 0 0

CT group 0 1 1 1

SCE= serial clinical exam; CT=computer tomography. Table 3. Complications.

Complications Infection Abdominal Thoracic Other

SCE group n(%) 4 (12.1) 1 (3.0) 2 (6.1) 0

CT group n(%) 3 (9.1) 1 (3.0) 2 (6.1) 1 (3.0)

Pa 0.689 1.000 1.000 0.314

SCE= serial clinical exam; CT=computer tomography; a Chi-square test. Table 4. Performance of serial clinical exam (SCE) and computer tomography (CT).

Sensitivity (%) Specificity (%) PPV (%) NPV (%) Accuracy (%)

SCE group (n=33) 100 100 100 100 100

CT group (n=33) 100 96.7 67.0 100 96.0

PPV: positive predictive value; NPV: negative predictive value.

with many different approaches. Abdominal CT, frequently used at trauma, has excellent results according to literature, and is included initially in many protocols21. The advantages are to highlight intraperitoneal and retroperitoneal lesions, as well as, in some circumstances, determinate the grade of penetration of abdominal wall. CT disadvantages are related to the use of intravenous contrast and possible adverse reactions, radiation and incapacity to detect diaphragmatic lesions or, occasionally, of small lesions of hollow viscera14. Berardoni et al.22 studied 98 patients with inclusion criteria for non-surgical management of anterior abdominal stab wounds and verified that CT had a sensitivity of 93%, specificity of 93%, predictive positive value of 70% and negative predictive value of 99%. Salim et al.21 published a retrospective observational study in order to verify validity of CT in patients with stab wound at anterior abdominal wall and concluded that CT must be associated with physical exam for better diagnostic performance. Another paper by Lee et al.13, in 2015, analyzed 108 patients with abdominal stab wounds submitted to abdominal CT, and in all, CT was positive. Authors concluded that CT, when positive, has high diagnostic value. However, when negative, does not rule de-

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Breigeiron Comparison between isolated serial clinical examination and computed tomography for stab wounds in the anterior abdominal wall

finitively out the possibility of abdominal lesion. In the present work, abdominal CT had a predictive positive value of 67% and negative of 100%. When we analyze these data, we verify that all patients with negative CT were not operated and were discharged from hospital. In relation to the three patients with positive CT and indication to surgery, two had lesions and one not, only the presence of blood in small quantity in the abdomen. In that case, CT showed free liquid without lesion of major viscera. Such findings proved that CT sensitivity for positive patients was very good, but with some lack of specificity, that is, capacity to detect truly negative patients. SCE is a diagnostic and semiological method that includes a systematic sequential anamnesis and physical exam, with defined intervals, to detect early alterations related to surgical lesion5. Ertekin el al.23 analyzed 117 patients with penetrating stab abdominal trauma and 79% were successfully treated without surgery by SCE, that included physical exam, leucogram and body temperature every four hours. The maximum period after which the patients presented symptoms was 20 hours. The present work showed that there are no difference of complications among patients initially operated and those who needed surgery after appearance of symptoms. Van Haarst et al.24 in a retrospective work of ten years analyzed efficiency of SCE in 370 consecutive patients with penetrating abdominal trauma (322 with stab wounds) and verified an important reduction of non-therapeutic laparotomies, from 24% to zero, in the last year of study, by using SCE. It is important to emphasize that there was no increase of morbidity and mortality in the operated group after beginning of symptoms. Clarke et al.25 emphasized the possibility of selective management with SCE, but highlighted that lesions at the epigastric and right hypochondrium regions should be cautiously evaluated and with higher attention. Alzamel et al.26, in another work, investigated what period after which the patients with stab abdominal wounds could be discharged from hospital. They showed that the maximum period of observation for appearance of symptoms was 12 hours. Most patients with penetrating abdominal wound not submitted to early surgery could be discharged from hospital after 24 hours of observation, as long as they

did not show any alteration of physical, image or laboratorial exams5,27. In the present work, among 33 patients randomized for SCE, only three were submitted to surgery and beginning of symptoms occurred at most in 18 hours. Those 30 patients not submitted to surgery were discharged from hospital without complications. It is important to emphasize that clinical exam included only anamnesis and physical exam, without laboratory exams. SCE had excellent capacity to detect patients with abdominal lesion before 24 hours, period in which post-operatory complications are small. It is important also to emphasize that correct selection of patients for SCE by strict criteria lowers very much the possibility of undetected intra-abdominal lesion at initial physical exam. When SCE and CT isolated are compared, management results were very similar in terms of sensitivity, specificity, predictive values and accuracy (Table 4). Variability of protocols show that exact definition of management of these patients is still missing3,4,6-11. Most protocols propose wound exploration in hemodynamically stable patients without peritoneal signs, followed by early laparotomy, SCE, FAST or CT if peritoneal violation is present or in doubt cases. SCE proved to be a reliable method in most studies, identifying patients that needed surgery within 24 hours after trauma, ruling out, efficiently, patients without the need for surgery. Non-surgical selective management of patients with anterior abdominal wall stab wounds must be based in strict criteria: patient must be hemodynamically stable, without peritoneal irritation, with score of 12 or more at the Glasgow coma scale, and without no surgical indication in any other surgical compartment. If these prerequisites are met, the chances of late lesion lowers very much and the patient may be submitted to isolated SCE without prejudice to morbidity, lowering costs, exposure to radiation, adverse effects of intravenous contrast and non-therapeutic laparotomies.

ACKNOWLEDGEMENT We particularly thank nurse Mรกrcia Koja Breigeiron for her invaluable help during the several phases of the study.

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R E S U M O Objetivo: comparar tomografia computadorizada de abdome (TC) com exame clínico seriado (ECS) isolado na condução de ferimentos por arma branca na região anterior do abdome. Métodos: estudo prospectivo, randomizado, realizado no Hospital de Pronto Socorro de Porto Alegre em que pacientes com ferimentos por arma branca na parede anterior do abdome, sem indicação de laparotomia imediata, foram divididos em dois grupos: grupo TC e grupo ECS, No grupo ECS, os pacientes eram observados com exame clínico seriado de 6/6h, No grupo TC, eram submetidos à tomografia computadorizada de abdome após a avaliação inicial. Resultados: dos 66 pacientes estudados, 33 foram selecionados para cada grupo, Do total, seis foram submetidos à cirurgia, três de cada grupo, No grupo ECS, pacientes submetidos à cirurgia tiveram média de 12h entre a chegada e o diagnóstico, sem laparotomias não terapêuticas, Os 30 pacientes restantes deste grupo receberam alta após 24h de observação, No grupo TC, três pacientes apresentaram alterações na TC e foram submetidos à laparotomia, uma não terapêutica, Os demais receberam alta após observação de 24h, A tomografia computadorizada de abdome apresentou valor preditivo positivo (VPP) de 67% e valor preditivo negativo (VPN) de 100%, com acurácia de 96%, O exame clínico seriado isolado, teve VPP e VPN de 100%, com acurácia de 100%. Conclusão: o manejo seletivo para ferimentos por arma branca na parede abdominal anterior é seguro, caso obedeça a uma seleção rigorosa dos pacientes, O exame clínico seriado isolado pode ser realizado sem a necessidade de tomografia, sem aumento do tempo de internação ou da morbidade, o que reduz custos, exposição à radiação, morbimortalidade e laparotomias não terapêuticas. Descritores: Tomografia Computadorizada de Emissão. Ferimentos Perfurantes. Abdome. Exame Físico.

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management and laparotomy in the management of stable patients with abdominal stab wound. Am J Emerg Med. 2012;30(7):1146-51. Omari A, Bani-Yaseen M, Khammash M, Qasaimeh G, Eqab F, Jaddou H. Patterns of anterior abdominal stab wounds and their management at Princess Basma teaching hospital North of Jordan. World J Surg. 2013;37(5):1162-8. Sumislawski JJ, Zarzaur BL, Paulus EM, Sharpe JP, Savage SA, Nawaf CB, et al. Diagnostic laparoscopy after anterior abdominal stab wounds: worth another look? J Trauma Acute Care Surg. 2013;75(6):1013-7; discussion 1017-8. Rezende Neto JB, Vieira Jr HM, Rodrigues BDL, Rizoli S, Nascimento B, Fraga GP. Management of stab wounds to the anterior abdominal wall. Rev Col Bras Cir. 2014;41(1):75-9. Biffl WL, Leppaniemi A. Management guidelines for penetrating abdominal trauma. World J Surg. 2015;39(6):1373-80. Quinn AC, Sinert R. What is the utility of the Focused Assessment with Sonography in Trauma (FAST) exam in penetrating torso trauma? Injury. 2011;42(5):482-7. Lee GJ, Son G, Yu BC, Lee JN, Chung M. Efficacy of computed tomography for abdominal stab wounds: a single institutional analysis. Eur J Trauma Emerg Surg. 2015;41(1):69-74. Brenner DJ, Hall EJ. Current concepts - Computed tomography - An increasing source of radiation exposure. New Eng J Med. 2007;357(22): 2277-84.

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Breigeiron Comparison between isolated serial clinical examination and computed tomography for stab wounds in the anterior abdominal wall

15. Shaftan GW. Indications for operation in abdominal trauma. Amer J Surg. 1960,99(5):657-64. 16. Sanei B, Mahmoudieh M, Talebzadeh H, Shahmiri SS, Aghaei Z. Do patients with penetrating abdominal stab wounds require laparotomy? Arch Trauma Res. 2013;2(1):21-5. 17. Murry JS, Hoang DM, Ashragian S, Liou DZ, Barmparas G, Chung Ret al. Selective nonoperative management of abdominal stab wounds. Am Surg. 2015;81(10):1034-8. 18. Hope WW, Smith ST, Medieros B, Hughes KM, Kotwall CA, Clancy TV. Non-operative management in penetrating abdominal trauma: is it feasible at a Level II trauma center? J Emerg Med. 2012;43(1):190-5. 19. Demetriades D, Hadjizacharia P, Constantinou C, Brown C, Inaba K, Rhee P, et al. Selective nonoperative management of penetrating abdominal solid organ injuries. Ann Surg. 2006;244(4):620-8. 20. Jansen JO, Inaba K, Rizoli SB, Boffard KD, Demetriades D. Selective non-operative management of penetrating abdominal injury in Great Britain and Ireland: survey of practice. Injury. 2012;43(11):1799-804. 21. Salim A, Sangthong B, Martin M, Brown C, Plurad D, Inaba K, et al. Use of computed tomography in anterior abdominal stab wounds: results of a prospective study. Arch Surg. 2006;141(8):745-50; discussion 750-2. 22. Berardoni NE, Kopelman TR, O’Neill PJ, August DL, Vail SJ, Pieri PG, et al. Use of computed tomography in the initial evaluation of anterior abdominal stab

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wounds. Am J Surg. 2011;202(6):690-5; discussion 695-6. Ertekin C, Yanar H, Taviloglu K, Güloglu R, Alimoglu O. Unnecessary laparotomy by using physical examination and different diagnostic modalities for penetrating abdominal stab wounds. Emerg Med J. 2005;22(11):790-4. van Haarst EP, van Bezooijen BP, Coene PPL, Luitse JS. The efficacy of serial physical examination in penetrating abdominal trauma. Injury. 1999;30(9):599-604. Clarke DL, Allorto NL, Thomson SR. An audit of failed non-operative management of abdominal stab wounds. Injury. 2010;41(5):488-91. Alzamel HA, Cohn SM. When is it safe to discharge asymptomatic patients with abdominal stab wounds? J Trauma. 2005;58(3):523-5. Martínez CI, Sancho IJ, Climent AM, Membrilla FE, Pons FM, Guzmán AJ, et al. A study of the predictive value of the primary review and complementary examinations in assessing the need for surgery in patients with stab wounds in the torso. Cir Esp. 2013;91(7):450-6.

Received in: 23/08/2017 Accepted for publication: 17/09/2017 Conflict of interest: none. Source of funding: none. Mailing address: Ricardo Breigeiron E-mail: rbreigeiron@gmail.com / carloscorso04@gmail.com

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Original Article

DOI: 10.1590/0100-69912017006010

Intravitreal injection of polysorbate 80: a functional and morphological study Injeção intravítrea de polissorbato 80: estudo funcional e morfológico FRANCISCO MAX DAMICO1; FÁBIO GASPARIN1; GABRIELA LOURENÇON IOSHIMOTO2; THAIS ZAMUDIO IGAMI1; ARMANDO SILVIA LIGORIO FIALHO4; ANDRE MAURICIO LIBER2; LUCY HWA-YUE YOUNG5; DORA FIX VENTURA2.

DA

SILVA CUNHA JR.3;

A B S T R A C T Objective: to determine the functional and morphological effects at rabbits retina of PS80 concentration used in the preparation of intravitreal drugs. Methods: eleven New Zealand rabbits received a intravitreal injection of 0.1ml of PS80. As control, the contralateral eye of each rabbit received the same volume of saline. Electroretinography was performed according to a modified protocol, as well as biomicroscopy and retina mapping before injection and seven and ten days after. Animals were euthanized in the 30th day and the retinas were analyzed by light microscopy. Results: eyes injected with PS80 did not present clinical signs of intraocular inflammation. Electroretinography did not show any alteration of extent and implicit time of a and b waves at scotopic and photopic conditions. There were no morphological alterations of retinas at light microscopy. Conclusion: intravitreal injection of PS80 in the used concentration for intravitreal drug preparations do not cause any functional or morphological alterations of rabbit retinas. These results suggest that PS80 is not toxic to rabbit retinas and may be safely used in the preparation of new lipophilic drugs for intravitreal injection. Keywords: Polysorbates. Retina. Electroretinography. Intravitreal Injections. Morphological and Microscopic Findings.

INTRODUCTION

D

rug access to the retina and choroid has always been a challenge to ophthalmologists due to the existence of two anatomic barriers (internal and external blood-retinal barriers) that impairs penetration of drugs in the posterior segment of ocular bulbus. Treatment of blindness secondary to most prevalent retina and choroid diseases (macular degeneration related to age and diabetic retinopathy) has changed dramatically with the use of intravitreal injection of therapeutic agents in the posterior segment of ocular bulbus1. Intravitreal injection of drugs overcomes external blood-retinal barrier and assures that retina and choroid receive therapeutic level of drugs, lowering significantly systemic absorption and consequent toxicity. According to Brazilian and World legislation, intravitreal injection of drugs is a surgical procedure and must be performed under rigorous aseptic technique.

Most commonly injected drugs in the vitreous are monoclonal antibodies (particularly inhibitors of the vascular endothelium growth factor), corticosteroids and antibiotics, but, in theory, any drug can be injected in the vitreous. However, some pharmacological aspects must be considered, such as the aqueous solubility, pharmacokinetics and biochemical proprieties of the compounds, as well as their interaction with the vitreous2. Polysorbates, a class of non-ionic surfactants, are very useful excipients in several pharmaceutic formulations for intravenous use with different objectives. Polysorbates increase drug solubility in suspensions with low or no-solubility, to obtain aqueous dispersions. In those cases, surfactant concentration varies from 0.05% to 0.5%, depending on the solid content of formulation. Polysorbates also are used in the formula of injectable solutions to increase absorption of soluble drugs due to micelle formation. Also, polysorbates are useful to sta-

1 - USP Medical School, Department of Ophthalmology and Otolaryngology, São Paulo, SP, Brazil. 2 - USP Institute of Psychology, Department of Experimental Psychology, São Paulo, SP, Brazil. 3 - UFMG School of Pharmacy, Department of Pharmaceutic Products, Belo Horizonte, MG, Brazil. 4 - Fundação Ezequiel Dias, Technologic Pharmaceutic Development Division, Belo Horizonte, MG, Brazil. 5 - Harvard Medical School, Department of Ophthalmology, Boston, MA, USA. Rev Col Bras Cir 2017; 44(6): 603-611


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bilize proteins in formulas with monoclonal antibodies. Virtually, all formulas contain polysorbate 20 or 80. Polysorbate 80, also known as polyoxietilensorbitan-20 mono-oleate or Tween 80® (MW: 428.60, FM: C24H44O6, aqueous solubility: 5-10g/100ml at 23oC) is a polysorbate used to stabilize aqueous formulations of drugs used topically, intravenously and intravitreal. It is also a solubilizer used in eye drops and an important component of lipophilic suspended drugs. Safety of systemic use of PS80 is controversial. PS80 has no neurotoxicity in newborn rats following administration of high oral doses during pregnancy, and do not cause development disturbances, functional alterations of central nervous system, and alterations of locomotion or of reflexes3. In adult animals, oral intake of high doses of PS80 is safe in mice, rats, dogs and apes4. However, intraperitoneal injection of PS80 in newborn female rats cause morphological and functional alterations of uterus and ovaries5. Also, PS80 may be associated to non-immune anaphylactic reaction, following intravenous administration during pregnancy6. PS80 effects on the eye surface were studied in several experimental models. Sub-tenon injection of PS80 in rabbits caused less toxicity in eye surface than other commonly used excipients commonly used in topic formulations for ocular use, such as carboxymethylcellulose, polyethylene glycol, benzylic alcohol, benzalkonium chloride and methylcellulose7. PS80 also seems to have a protective mechanism in the corneal epithelium of cells maintained in culture, reducing the toxicity induced by benzalkonium chloride, a commonly used excipient used in eye drops8,9. Formula most used commercially of triamcinolone acetonide (TA) contains PS80. TA is a synthetic glucocorticoid with long-lasting effect that has been widely used in the treatment of retinal diseases by intravitreal injection, but safety studies show controversial results. Some in vivo experimental studies suggest that TA intravitreal injection, which formula contains PS80, is safe1012 . However, other experimental studies suggest that TA formulation without preservative is less toxic to retina after intravitreal injection than most common formulas13-15. Since TA vehicle formulation has many compounds, such as benzylic alcohol, carboxy-methylcellulose, PS80, sodium hydroxide and hydrochloric acid, the role

of each compound in retinal toxicity is still uncertain16-18. Although PS80 is frequently used in the preparation of formulations for ocular use, including drugs for intravitreal use, its effect on retina after intravitreal injection has never been studied. The objective of the present study is to determine functional and morphological alterations of rabbit retina caused by PS80, at the same concentration used for the preparation of new drugs for intravitreal use.

METHODS Eleven New Zealand non-pigmented rabbits (weighting from 2 to 3 kg) were used. Animals were treated according to the recommendations of the Association for Research in Vision and Ophthalmology Statement for the Use of Animals in Ophthalmic and Vision Research. Experiments were approved by the Ethic Commission of Animal Experimentation of Biomedical Science Institute of the University of São Paulo #029, sheet 43, book 2, and by the Ethic Commission of Research in Animals of the Psychological Institute of University of São Paulo (#07.2010). Animals were kept in individual cages in a cleardark cycle of 12 hours, and free access to water and food. Pupils were dilated with tropicamide 0.5% eye drops and eyes were anesthetized with proxymetacaine eye drops. Before intravitreal injection, electroretinography and euthanasia, animals were anesthetized with intramuscular injection of ketamine hydrochloride (35mg/ kg) and xylazine hydrochloride (5mg/kg). Animals were sacrificed by intravenous injection of sodium pentobarbital (40mg/kg).

Intravitreal Injection Right before intravitreal injection, it was performed paracentesis of anterior camera (30G needle), removing 0.1ml of aqueous humor to avoid significant increase of ocular pressure. Under direct visualization, right eye of each animal were submitted to an intravitreal injection of 0.1ml of PS80 (0.4% w/v, pH 6.6-6.8, osmolarity 288-318mOsm/kg H2O) using a 30G needle attached to a tuberculin syringe. Intravitreal injection was performed approximately at 3mm posterior to lim-

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bo. Left eye received an intravitreal injection of sterile saline and used as control.

Ophthalmologic Exam Animals were submitted to biomicroscopy and indirect binocular ophthalmoscopy before and right after intravitreal injections, repeated in the 7th and 14th days after injections.

Electroretinography Both eyes were submitted to full-field electroretinography (ERG) before and after seven and 14 days of injection. For ERG, contact lens were applied attached to bipolar corneal electrodes in both eyes and a ground electrode was fixed at the animal ear. Animals were positioned in a Faraday cage (60x60cm) and the luminous stimulation was generated by a Ganzfeld stimulator controlled by a computer system. ERG signs were amplified and digitalized. Data were analyzed by LabVIEW® computer software. Luminous stimuli band was calibrated to vary from 0.3 to 1000 Hz. The protocol used for ERG acquisition was the one suggested by the International Society for Clinical Electrophysiology of Vision (ISCEV)19 modified for acquirement of some additional information in experimental studies. For obtaining scotopic answers, animals were adapted in the dark for 30 minutes and were submitted to stimuli with five different luminous intensity (0.001, 0.01, 0.1, 1 and 10 cd.s/m2). After adaptation for ten minutes to light, they were submitted to luminous stimuli with 1cd.s/m2 with background illumination of 25cd/m2. A and b waves were recorded and their amplitude and implicit time were analyzed. A wave amplitude was measured from baseline to minimum amplitude registered after presentation of stimuli. Implicit time was measured from the beginning of luminous stimulus until the a wave peak. B wave amplitude was measured from a wave peak to b wave peak, and the implicit time of b wave corresponded to the necessary time for that peak. ERG dynamic interval at scotopic condition was evaluated by a graphic of median amplitude versus luminous stimulus intensity. Curves were obtained

605

by the equation of Naka-Rushton: V=Vmax. In/Kn + In; Vmax is the saturation amplitude of b wave, I is the intensity of luminous stimulus, K is necessary luminous intensity for obtaining 50% of Vmax and n is the curve inclination, representing the dynamic interval of the measured wave.

Morphological Analysis Animals were sacrificed 30 days after intravitreal injections and their eyes were processed for light microscopy, after euthanasia, posterior eye segments were fixed in ALFAC solution. After inclusion in paraffin, they were submitted to 7µm slices that were dyed with hematoxylin and eosin and analyzed under light microscopy. Thickness and retinal organization were analyzed at retinal inferior medium periphery of all eyes.

Statistical Analysis Amplitude and implicit times were described as medium ± standard deviation. Results were analyzed by ANOVA variance analysis test using repeated measures. Fisher test was used as post hoc test to determine significant difference among medias identified by ANOVA. Naka-Rushton equation parameters (b wave amplitude versus intensity of luminous stimulus) were initially evaluated by ANOVA variance analysis test of one and two factors, with adequate Bonferroni correction to the number of comparisons between groups and intervals. Differences were considered significant when p was lower than 0.05.

RESULTS Clinical Aspects No alterations were observed at biomicroscopy and indirect binocular ophthalmoscopy during the follow-up period (cataract, cells at anterior and posterior cameras, retinal lesion and endophthalmitis).

Electroretinography Figure 1 shows scotopic and photopic ERG

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registers of one animal before and after (7 and 30 days) intravitreal injection of PS80 in the right eye and sterile saline in left eye. Visual inspection of ERG waves donâ&#x20AC;&#x2122;t suggest secondary alteration of PS80 in the comparison of the day of intravitreal injection and after seven and 30 days.

Figure 1. Representative electroretinograhy results.

To evaluate the dynamic interval of ERG at scotopic condition, graphics of median amplitude versus intensity of luminous stimulus were performed. Figure 2 shows that intravitreal injection of PS80 did not alter the dynamic interval of ERG compared to sterile saline injection. Obtained curve parameters (Vmax, k and n) did not vary during time when the results of seven and 30 days were compared (p>0,05). Functional effects on retina of intravitreal injection of PS80 were also analyzed by the Vmax relation (experimental eye/control eye) of b wave at scotopic state and of b wave amplitude relation (experimental eye/control eye) at photopic condition. Register analysis donâ&#x20AC;&#x2122;t show any alteration of the function of cones and rods (p>0.05). Figure 3 shows these results. ERG scotopic and photopic registers were not affected by intravitreal injection of PS80 at days zero, seven and 30, as observed in figure 4, that shows the relation between wave b scotopic retinal function [ratio Vmax (experimental eye/control eye) at scotopic state] and photopic [ratio wave b amplitude (experimental eye/control eye) at photopic condition].

Figure 2. Scotopic b wave amplitude x luminous stimulus.

Figure 3. Ratio of scotopic Vmax x photopic b wave amplitude.

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Intravitreal injection effects of PS80 in the relationship between a and b waves were also analyzed by amplitude graphics of b wave in relation to a wave amplitude in all luminous intensities that generated detectable and measurable a waves (0.1, 1 and 10 cd.s/ m2 at scotopic condition and 1cd.s/m2 at photopic condition). Figure 5 demonstrates that PS80 intravitreal injection did not cause functional significant alterations when compared to sterile saline injection at the 7th and 30th days after intravitreal injections in both tested conditions (scotopic and photopic).

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Histology Figure 6 shows representative histology images of right eye (PS80) and left eye (sterile saline) of the same animal. Thirty days after PS80 intravitreal injection, eyes did not present any histologic alteration under light microscopy compared to eyes that received intravitreal injection of sterile salinel.

DISCUSSION In this experimental study, retinal functional and morphological effects of intravitreal injection of PS80 in rabbits were analyzed. Obtained results suggest that PS80 concentration used in this study (the same used in preparation of drugs for intravitreal use to treat retina diseases (0.4% w/v) is not toxic to rabbit retinas. PS80 is a widely used component in the preparation of foods, vitamins, drugs and vaccines. PS80 stabilize aqueous formulas of drugs used intravenously; it is an emulsifier present in several drugs

Figure 4. Scotopic and photopic retinal function.

Figure 5. B wave amplitude x stocopic and photopic a wave.

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Figura 6. Histologia retiniana antes e 30 dias após PS80.

(amiodarone, ciclosporin and decetaxel)20 and it is used as excipient in vaccines21. Although PS80 is usually considered a safe component for systemic use and of several drugs for intravitreal use that include it in their formula, clinical and experimental studies of its safety are controversial, regarding intravitreal injections9,13-15,22. Since formula of drugs injected at vitreous contain many other agents (preservatives, surfactants, solvent and agents that stabilize pH and tonicity), the role of each agent regarding retinal toxicity is still uncertain16-18,23. One of the agents present in TA preparation injected in vitreous is benzylic alcohol, that has preservative and antibacterial proprieties. It has already been shown that benzylic alcohol causes early non-immunologic contact reaction in humans. Also, experimental data on teratogenesis and toxicity to reproductive processes are still controversial24. Maia et al.15 evaluated clinical and morphological alterations of rabbits retina secondary to sub-retinal injection of supernatants of TA solutions containing benzylic alcohol or not. Both tested solutions contained PS80 in their formula. Authors showed that eyes injected with TA supernatant that did not contain benzylic alcohol had lower grade of retinal lesion, suggesting that the presence of benzylic alcohol may, at least in part, be related to retinal toxicity. Biochemical parameters also have a very important role in drug retinal toxicity. Osmolarity and pH may be responsible for alterations detected at ERG, indirect binocular ophthalmoscopy, angiography with fluorescein and histology25-28. Eyes that received intravitreal injections of compounds with non-physiologic pH and osmolarity may present retinal detachment27, alterations of a and b waves at ERG (lowering of amplitude and increase of implicit time)25-27 and extra- and intracellular edema25. PS80 used in this study is the commercially

available formula that is universally used in the preparation of drugs for intravitreal use (Tween® 80). Tween® 80 has a pH very close to normal (6.6-6.8), and is iso-osmolar (288 a 318 mOsm/kg H2O). Therefore, it is very unlikely that biochemical factors associated to PS80 used in this study (such as pH and osmolarity) may cause retinal toxicity. Since this is the first publication about the retinal effects of intravitreal injection of PS80, it is not possible to compare it directly with other results. However, PS80 is present is several drugs that are injected in vitreous of animals and studies don’t show any retinal toxicity, such as Triesence® (a new TA formulation without preservative, specifically produced for intravitreal injection), Remicade® (infliximabe)29-31 and Humira® (adalimumabe)32-34. These last two are monoclonal antibodies that block tumor necrosis factor approved for the treatment of gastrointestinal, rheumatic and dermatologic diseases, that have been used for the treatment of auto-immune uveitis. This study has some limitations. Only one concentration of PS80 was tested. It did not allow us to determine the maximal safe dose for intravitreal injection, but the concentration tested is used in all formulations of drugs for intravitreal use. Also, no immune-histochemical analysis or ultramicroscopic studies were performed to detect subtle or subclinical alterations of retinal toxicity. This is an experimental study and the results may not represent integrally the findings of human inflamed eyes. Limitations of the use of rabbit eyes in the studies of drug retinal toxicity include retinal vascularization differences in relation to human eye, and differences of the eye volume of rabbits and humans. In spite of the cited limitations, this study results have low variability, in special of ERG results, even considering that exists several variability factors that are very difficult to control in studies with ERG in animals, that could influence the results35. This study suggests that PS80, at the used concentration in the preparation of drugs for intravitreal use, is not toxic to rabbits retina and may be used safely as a component of the preparation of suspension of lipophilic drugs. However, pharmacological and additional retinal toxicity studies are needed to determine the safety of PS80 in multiple intravitreal injections in the same eye, since this is a very common treatment in daily practice.

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R E S U M O Objetivo: determinar os efeitos funcionais e morfológicos na retina de coelhos da concentração de PS80 utilizada na preparação de drogas intravítreas. Métodos: onze coelhos New Zealand receberam injeção intravítrea de 0,1ml de PS80. Como controle, o olho contralateral de cada coelho recebeu o mesmo volume de soro fisiológico. Foram realizados eletrorretinogramas de acordo com o protocolo modificado, biomicroscopia e mapeamento de retina antes da injeção, sete e dez dias depois. Os animais foram sacrificados no 30o dia e as retinas analisadas por microscopia de luz. Resultados: os olhos injetados com PS80 não apresentaram sinais clínicos de inflamação intraocular. O eletrorretinograma não apresentou alteração de amplitude e tempo implícito das ondas a e b nas condições escotópica e fotópica. Não houve alteração morfológica da retina na microscopia de luz. Conclusão: a injeção intravítrea de PS80 na concentração utilizada na preparação de drogas intravítreas não causa alterações funcionais e morfológicas na retina de coelhos. Esses resultados sugerem que o PS80 não é tóxico para a retina de coelhos e pode ser usado com segurança na preparação de novas drogas lipofílicas para injeção intravítrea. Descritores: Polissorbatos. Retina. Eletrorretinografia. Injeções Intravítreas. Achados Morfológicos e Microscópicos.

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79. Liang C, Peyman GA, Sun G. Toxicity of intraocular lidocaine and bupivacaine. Am J Ophthalmol. 1998;125(2):191-6. Marmor MF. Retinal detachment from hyperosmotic intravitreal injection. Invest Ophthalmol Vis Sci. 1979;18(12):1237-44. Verstraeten TC, Chapman C, Hartzer M, Winkler BS, Trese MT, Williams GA. Pharmacologic induction of posterior vitreous detachment in the rabbit. Arch Ophthalmol. 1993;111(6):849-54. Giansanti F, Ramazzotti M, Vannozzi L, Rapizzi E, Fiore T, Iaccheri B, et al. A pilot study on ocular safety of intravitreal infliximab in a rabbit model. Invest Ophthalmol Vis Sci. 2008;49(3):1151-6. Theodossiadis PG, Liarakos VS, Sfikakis PP, Charonis A, Agrogiannis G, Kavantzas N, et al. Intravitreal administration of the anti-TNF monoclonal antibody infliximab in the rabbit. Graefes Arch Clin Exp Ophthalmol. 2009;247(2):273-81. Giansanti F, Papucci L, Capaccioli S, Bacherini D, Vannozzi L, Witort E, et al. Ocular safety of infliximab in rabbit and cell culture models. J Ocul Pharmacol Ther. 2010;26(1):65-71. Manzano RP, Peyman GA, Carvounis PE, Kivilcim M, Khan P, Chevez-Barrios P, et al. Ocular toxicity of intravitreous adalimumab (Humira) in the rabbit. Graefe’s Arch Clin Exp Ophthalmol. 2008;246(6):907-11. Manzano RP, Peyman GA, Carvounis PE, Damico FM, Aguiar RG, Ioshimoto GL, et al. Toxicity of highdose intravitreal adalimumab (Humira) in the rabbit. J Ocul Pharmacol Ther. 2011;27(4):327-31. Myers AC, Ghosh F, Andréasson S, Ponjavic V. Retinal function and morphology in the rabbit eye after intravitreal injection of the TNF alpha inhibitor adalimumab. Curr Eye Res. 2014;39(11):1106-16. Perlman I. Testing retinal toxicity of drugs in animal models using electrophysiological and morphological techniques. Doc Ophthalmol. 2009;118(1):3-28.

Received in: 30/07/2017 Accepted for publication: 23/08/2017 Conflict of interest: none.

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Damico Intravitreal injection of polysorbate 80: a functional and morphological study

Source of funding: FAPESP 2007/02696-1 FAPESP 2007/56624-1 FAPESP 2014/26818-2 CNPq 150614/2009-8.

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Mailing address: Francisco Max Damico E-mail: fmdamico@usp.br / fmdamico@yahoo.com

Rev Col Bras Cir 2017; 44(6): 603-611


Original Article

DOI: 10.1590/0100-69912017006013

Identification of the sentinel lymph node using hemosiderin in locally advanced breast cancer Identificação do linfonodo sentinela utilizando hemossiderina em casos de câncer de mama localmente avançado PAULO HENRIQUE WALTER DE AGUIAR, ACBC-CE1; RANNIERE GURGEL FURTADO DE AQUINO1,4; MAYARA MAIA ALVES2; JULIO MARCUS SOUSA CORREIA3; AYANE LAYNE DE SOUSA OLIVEIRA4; ANTÔNIO BRAZIL VIANA JÚNIOR5; LUIZ GONZAGA PORTO PINHEIRO, ECBC-CE1. A B S T R A C T Objective: to verify the agreement rate in the identification of sentinel lymph node using an autologous marker rich in hemosiderin and 99 Technetium (Tc99) in patients with locally advanced breast cancer. Methods: clinical trial phase 1, prospective, non-randomized, of 18 patients with breast cancer and clinically negative axilla stages T2=4cm, T3 and T4. Patients were submitted to sub-areolar injection of hemosiderin 48 hours prior to sentinel biopsy surgery, and the identification rate was compared at intraoperative period to the gold standard marker Tc99. Agreement between methods was determined by Kappa index. Results: identification rate of sentinel lymph node was 88.9%, with a medium of two sentinel lymph nodes per patients. The study identified sentinel lymph nodes stained by hemosiderin in 83.3% patients (n=15), and, compared to Tc99 identification, the agreement rate was 94.4%. Conclusion: autologous marker rich in hemosiderin was effective to identify sentinel lymph nodes in locally advanced breast cancer patients. Keywords: Breast Neoplasms. Sentinel Lymph Node Biopsy. Hemosiderin. Technetium.

INTRODUCTION

S

entinel lymph node (SL) is the first lymph node that receives lymphatic drainage of a particular primary tumor location1. Cabanas1, in 1977, studied penile adenocarcinoma patients and stablished for the first time the technique to perform biopsy of sentinel lymph node (BSL). In order to improve identification rate of SB in melanoma patients, Krag et al.2, in 1993, used Technetium 99 (Tc99) successfully. Later, in 1994, Giuliano et al.3, using patent blue as marker for SL in breast cancer, introduced the concept of biopsy of SL (BSL) in daily practice. In 2003, Veronesi et al.4 stated that BSL is a safe and accurate method to evaluate axillary metastasis in women with small breast tumors. Nowadays, BSL replaced axillary lymphadenectomy at initial breast cancer staging in patients with clinically negative axilla5. The association of Tc99 and patent blue marker was more accurate to identify BSL6,7. Other

markers have been used in the identification of SB during surgical procedure, such as methylene blue, patent blue and isosulfan8. However, those substances, in a recent literature review, present a high number of hypersensitivity reactions9,10. Patent blue may cause subtle adverse effects, such as cutaneous rash, or even severe, such as anaphylaxis11,12. Methylene blue may also cause severe reactions, including skin and fat necrosis at the site of injection13. Anaphylactic reactions with isosulfan and patent blue in patients submitted to BSL vary from 0.6% to 2.7%14. In 2009, Pinheiro et al.15 proved, in animal experimental study, the efficiency of hemosiderin, a product of hemoglobin degradation and a protein usually found in lysosomes of histiocytes and in Kupfer cells, as an autologous marker of BSL in bitches breasts. In that study, association of hemosiderin and Tc99 has shown similar results of the association of Tc99 and patent blue in BSL. Experimentally, hemosiderin proved to be a new

1 - Federal University of Ceará, Medical Surgical Sciences Post-Graduate Program, Fortaleza, CE, Brazil. 2 - Federal University of Ceará, Biotechnology Post-Graduate Program (RENORBIO), Fortaleza, CE, Brazil. 3 - SONIMAGEM, Image Diagnosis, Fortaleza, CE, Brazil. 4 - Fortaleza University School of Medicine, Fortaleza, CE, Brazil. 5 - Ceará Federal University, Walter Cantídio University Hospital, Fortaleza, CE, Brazil. Rev Col Bras Cir 2017; 44(6): 612-618


Aguiar Identification of the sentinel lymph node using hemosiderin in locally advanced breast cancer

marker without adverse reactions and an alternative to current markers. In 2015, Vasques et al.16 introduced the studies with hemosiderin in initial human breast cancer (T1/ T2) with clinically negative axilla, and success (identification) and agreement rates of 100% compared to gold standard (Tc99). In view of those results, the present study proposal was to evaluate the efficacy of hemosiderin to identify sentinel lymph node in patients with locally advanced breast cancer (T2>4cm/T3/T4), compared to TC99 gold standard test.

METHODS Phase 1 clinical trial, prospective, non-randomized, that studied women with locally advanced breast cancer. Surgical procedures were performed at Maternidade Escola Assis Chateaubriand (MEAC) and Walter Cantídio University Hospital by a single surgeon from January to December 2016. The study was approved by the Research Ethical Committee of Hospital Universitario Walter Cantidio of Federal University of Ceará, # 2.032.200. Each patient was informed and signed a Free Consent Form to participate.

Sampling and selection criteria Sample included 18 women, non-randomized, selected at Mastology Ambulatory of Maternidade Escola Assis Chateaubriand (MEAC), with indication of BSL. Patients were 18 to 75 years old, and had breast cancer with pathologic proved diagnosis, stages II (≥4cm), III and IV and clinically negative axilla before neoadjuvant chemotherapy. Patients with inflammatory breast cancer, pregnant women, those who had received any chemotherapy or neoadjuvant radiotherapy or that had been submitted to axillary surgery and/or previous incisional biopsy that could have compromised breast lymphatic drainage were excluded. One week before the beginning of the study, all participants were submitted to clinical evaluation and pre-operatory laboratory tests, being fit for surgical procedure. Iron profile was also previously evaluated by complete blood count, serum iron, serum ferritin, transferrin saturation and iron total ligand capacity.

613

Preparation of marker rich in hemosiderin Hemosiderin preparation for use at the study was obtained in a 16ml of peripheral blood sample 48 hours before surgery. Collected blood was maintained in two aseptic BD Vacutainer® tubes containing buffered Sodium Citrate. Next, the tubes were centrifuged at 2000rpm at 22oC for ten minutes. Centrifuged material were distributed in three layers: the superior and intermediate (serum) were discharged and the inferior (red cells) was diluted with equal volume that was removed, and manually homogenized with saline in a laminar flow chamber. The obtained solution was again centrifuged (3800rpm for three minutes) and two layers were produced. The first was discharged and the volume was replaced by double distilled water at the laminar flow chamber, causing hemolysis of the packed red cells. After the third and last centrifugation (3800rpm for three minutes), it was obtained a single layer of lysate red cells, rich in hemosiderin, suspended in a reddish liquid. Sterility control was verified by the use of bacterial and fungus cultures. Four milliliters of marker rich in hemosiderin was injected ambulatorily; patient was kept in dorsal decubitus, under local anesthesia with 2% lidocaine without adrenalin at the external breast periareolar region (at 3h position), using a single injection with aseptic technique (Figures 1A and 1B). Patients were admitted and followed up for collateral effects for 24 hours. Before surgical procedure, each patient received a subareolar intradermal infection of 0.2ml of Tc99, and, following local anesthesia and sedation, were submitted to surgical procedure.

Procedure: biopsy of sentinel lymph node (BSL) Patients were submitted to BSL, incising the axillary fold, guided by gamma-probe. Dissection proceeded until identification of maximal point of Tc99 captation, and marked lymph node was identified and its color was noted (Figures 2A and 2B). After lymph node removal, Tc99 intensity detection of each was verified by gamma-probe. Those data were registered in a proper sheet for posterior analysis.

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pausal. At histology, all patients had invasive tumor, 17 with ductal tumor. T3 staging was the most frequent and 55% of patients had a positive axillary study at pathology (Table 1). There were no adverse effects and/ or allergic reactions, surgical infection or toxicity in all patients submitted to BSL with hemosiderin in this study. At surgery, marking with hemosiderin was extremely satisfactory for visual identification and differentiation of SL from all other axillary lymph nodes (Figure 3). Efficacy of BSL with hemosiderin was compared to gold-standard technique with Tc99 and the results were satisfactory. Identification rate of SL was 88.9% and a medium of two SB were found by patient. The study identified SL marked with hemosiderin in 83.3% of patients (n=15) and, compared to Tc99 identification, agreement was observed in 94.4% of studied patients, Kappa index =0.77 and p=0.001 (Figure 4).

Figure 1. A ) Subareolar injection of hemosiderin; B) Site post-injection of hemosiderin (hematoma post-injection).

All surgical samples were submitted to pathologic and immune histochemical studies. Patients were followed up during all procedure, since hemosiderin injection until post-operatory and consultation after 15 and 30 days of surgery.

Statistical analysis Data were evaluated by Kappa Coefficient Agreement. P values were determined by Fisher exact test. P values â&#x2030;¤0.05 were considered statistical significant.

RESULTS Eighteen patients were submitted to BSL with hemosiderin according to described method. Mean age of patients was 48.2 years and 63.7% were pre-meno-

Figure 2. A) Intraoperative identification of sentinel lymph node using Gamma-Probe; B) Sentinel lymph nodes strongly stained with hemosiderin.

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Table 1. Clinical and pathological data of studied patients and respective analyzed tumors.

Characteristics

Value

Age (medium years) 48.2 ( 33 - 69 Âą 11) Menopausa status Pre-menopausa n=12 (66.7%) Post-menopausa 7 (33.3%) Invasion Grade Invasive carcinoma 18 (100%) Carcinoma in situ 0 (0%) Location of primary tumor External superior quadrant 11(60.5%) Internal superior quadrant 3 (16.5%) External inferior quadrant 2 (11.1%) Internal inferior quadrant 1 (5.5%) Central 1 (5.5%) Tumor size T2=4cm T3 1(5.4%) 14(77.8%) T4C 3 (16.6%) Lymph node status Negative sentinel lymph node 10 (55.5%) Positive sentinel lymph node 8 (44.5%) Histologic subtype Ductal 17 (94.5%) Lobular 1 (5.5%)

DISCUSSION At medical literature, studies performed in several conditions showed adequate agreement with our results. Krag et al. study 2 analyzed 443 patients and identification rate was 93%. Albertini et al.17 associated two techniques (patent blue and radiocolloid) and observed an increase of SL identification rate to 92% with predictive value of 100%. Veronesi et al.4 showed a 98.2% identification rate with 2.5% of false negative. Possible failures of identification rate may be caused by inherent technical, physician and patients factors. When patients submitted to neoadjuvant chemotherapy followed by BSL are studied, iden-

Figure 3. A) Macroscopic stained SL with hemosiderin and another non-stained axillary lymph node; B) Intraoperative aspect of strongly stained SB.

tification rate may be lower due to chemotherapy effects. Breslin et al. study 18 found an identification rate of 84%. Other studies showed identification rates varying from 85% to 98% (as quoted by Xing et al. study 19). Jones et al. 20 compared BSL before and after neoadjuvant chemotherapy and found a respective rate of identification of 100% and 80.6%, and a higher false negative rate in post-chemotherapy group (11%). In the series studied by Cox et al. 21, including 89 patients with locally advanced breast cancer, stratified in two groups (positive and negative axilla), it was observed that BSL before chemotherapy had an adequate accuracy for negative axilla. Papa et al. study 22 compared sentinel lymph node biopsy before and after chemotherapy and the iden-

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Figura 4. A) Hemosiderin and TC99-stained SL per patients; B) Agreement rate of hemosiderin and Tc99 with statistical significance.

tification rate was 98.8% and 87%, respectively. Other markers for SL have been studied and the supermagnetic iron nanoparticle had an identification rate of 77%, inferior to those observed with the use of hemosiderin as autologous marker in 14 patients submitted to BSL that showed an identification rate of 100% and agreement rate of 100% 16. In our series of 18 patients, in 16, SL was identified using radiocolloid and in 15 using hemosiderin, with an agreement rate of 94.4%.In only one patient, there was discrepancy (identification of lymph node by radiopharmaceutical agent and not by hemosiderin). Probable causes include size of hemosiderin molecule, since big molecules may not reach lymphatic

vessels, preventing migration to lymph node. It is observed a tendency to avoid the use of radioisotope and patient exposure to radiation, and of patent blue, due to potentially severe adverse reactions. In facilities with adequate nuclear medicine departments, costs are elevated (particularly of gamma-probe) and radioisotope half-life is short. The studied autologous marker was safely injected 48 hours before surgery, without any adverse reaction. Our study suggests that the use of hemosiderin as an autologous marker is useful at daily clinical practice, to identify sentinel lymph node in locally advanced breast tumors.

R E S U M O Objetivo: verificar a taxa de concordância na identificação do linfonodo sentinela utilizando um marcador autólogo rico em hemossiderina e o Tecnécio 99 (Tc99) em casos de câncer de mama localmente avançados. Métodos: ensaio clínico fase 1, do tipo prospectivo, não randomizado, em 18 pacientes portadoras de câncer de mama com axila clinicamente negativa em estádio T2=4cm, T3 e T4. As pacientes foram submetidas à injeção sub-areolar de um marcador autólogo rico em hemossiderina 48 horas antes do procedimento cirúrgico para biópsia do linfonodo sentinela, e sua taxa de identificação foi comparada, no intraoperatório, com o marcador radioativo Tc99 (padrão-ouro). A concordância entre os métodos foi estabelecida pelo índice de Kappa. Resultados: a taxa de identificação do linfonodo sentinela foi de 88,9%, com uma média de dois linfonodos sentinelas por paciente. O estudo identificou os linfonodos sentinelas corados com hemossiderina em 83,3% dos casos (n=15), quando comparados com a taxa de identificação do Tc99, tendo sido observada concordância em 94,4% dos casos estudados. Conclusão: o marcador autólogo rico em hemossiderina se mostrou eficaz na identificação do linfonodo sentinela em casos de câncer de mama localmente avançado. Descritores: Neoplasias da Mama. Biópsia de Linfonodo Sentinela. Hemossiderina. Tecnécio.

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Cabanas RM. An approach for the treatment of penile carcinoma. Cancer. 1977;39(2):456-66. 2. Krag DN, Weaver DL, Alex JC, Fairbank JT. Surgical resection and radiolocalization of the sentinel lymph node in breast cancer using a gamma probe. Surg Oncol. 1993;2(6):335-9; discussion 340. 3. Giuliano AE, Kirgan DM, Guenther JM, Morton DL. Lymphatic mapping and sentinel lymphadenectomy for breast cancer. Ann Surg. 1994;220(3):391-8; discussion 398-401. 4. Veronesi U, Paganelli G, Viale G, Luini A, Zurrida S, Galimberti V, et al. A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. N Engl J Med. 2003;349(6):546-53. 5. Lyman GH, Temin S, Edge SB, Newman LA, Turner RR, Weaver DL, Benson AB 3rd, Bosserman LD, Burstein HJ, Cody H 3rd, Hayman J, Perkins CL, Podoloff DA, Giuliano AE; American Society of Clinical Oncology Clinical Practice. Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2014;32(13):1365-83. 6. Rutgers EJ. Guidelines to assure quality in breast cancer surgery. Eur J Surg Oncol. 2005;31(6):56876. 7. Straver ME, Meijnen P, van Tienhoven G, van de Velde CJ, Mansel RE, Bogaerts J, et al. Sentinel node identification rate and nodal involvement in the EORTC 10981-22023 AMAROS trial. Ann Surg Oncol. 2010;17(7):1854-61. 8. Thill M, Kurylcio A, Welter R, van Haasteren V, Grosse B, Berclaz G, et al. The Central-European SentiMag study: sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope. Breast. 2014;23(2):175-9. 9. Kalimo K, Jansén CT, Kormano M. Sensitivity to Patent Blue dye during skin-prick testing and lymphography. A retrospective and prospective study. Radiology. 1981;141(2):365-7. 10. Mertes PM, Malinovsky JM, Mouton-Faivre C, Bonnet-Boyer MC, Benhaijoub A, Lavaud F, et al. Anaphylaxis to dyes during the perioperative period: reports of 14 clinical cases. J Allergy Clin Immunol.

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2008;122(2):348-52. Haque RA, Wagner A, Whisken JA, Nasser SM, Ewan PW. Anaphylaxis to patent blue V: a case series and proposed diagnostic protocol. Allergy. 2010;65(3):396-400. Wöhrl S, Focke M, Hinterhuber G, Stingl G, Binder M. Near-fatal anaphylaxis to patent blue V. Br J Dermatol. 2004;150(5):1037-8. Salhab M, Al Sarakbi W, Mokbel K. Skin and fat necrosis of the breast following methylene blue dye injection for sentinel node biopsy in a patient with breast cancer. Int Semin Surg Oncol. 2005;2:26. Scherer K, Studer W, Figueiredo V, Bircher AJ. Anaphylaxis to isosulfan blue and cross-reactivity to patent blue V: case report and review of the nomenclature of vital blue dyes. Ann Allergy Asthma Immunol. 2006;96(3):497-500. Pinheiro LG, Oliveira Filho RS, Vasques PH, Filgueira PH, Aragão DH, Barbosa PM, et al. Hemosiderin: a new marker for sentinel lymph node identification. Acta Cir Bras. 2009;24(6):432-6. Vasques PH, Alves MM, Aquino RG, Torres RV, Bezerra JL, Brasileiro LP, et al. Comparison between hemosiderin and Technetium-99 in sentinel lymph node biopsy in human breast cancer. Acta Cir Bras. 2015;30(11):785-90. Albertini JJ, Lyman GH, Cox C, Yeatman T, Balducci L, Ku N, et al. Lymphatic mapping and sentinel node biopsy in the patient with breast cancer. JAMA. 1996;276(22):1818-22. Breslin TM, Cohen L, Sahin A, Fleming JB, Kuerer HM, Newman LA, et al. Sentinel lymph node biopsy is accurate after neoadjuvant chemotherapy for breast cancer. J Clin Oncol. 2000;18(20):3480-6. Xing Y, Cormier JN, Kuerer HM, Hunt KK. Sentinel lymph node biopsy following neoadjuvant chemotherapy: review of the literature and recommendations for use in patient management. Asian J Surg. 2004;27(4):262-7. Jones JL, Zabicki K, Christian RL, Gadd MA, Hughes KS, Lesnikoski BA, et al. A comparison of sentinel node biopsy before and after neoadjuvant chemotherapy: timing is important. Am J Surg. 2005;190(4):517-20. Cox CE, Cox JM, White LB, Stowell NG, Clark JD, Allred N, et al. Sentinel node biopsy before

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neoadjuvant chemotherapy for determining axillary status and treatment prognosis in locally advanced breast cancer. Ann Surg Oncol. 2006;13(4):483-90. 22. Papa MZ, Zippel D, Kaufman B, Shimon-Paluch S, Yosepovich A, Oberman B, et al. Timing of sentinel lymph node biopsy in patients receiving neoadjuvant chemotherapy for breast cancer. J Surg Oncol. 2008;98(6):403-6.

Received in: 16/08/2017 Accepted for publication: 17/09/2017 Conflict of interest: none. Source of funding: none. Mailing address: Luiz Gonzaga Porto Pinheiro E-mail: luizgporto@uol.com.br

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Original Article

DOI: 10.1590/0100-69912017006014

Can renal stone size and the use of the nephrolithometric system increase the efficacy of predicting the risk of failure of percutaneous nephrolithotripsy? O tamanho do cálculo renal e o uso do sistema nefrolitométrico podem aumentar a eficácia de predizer o risco de falha de nefrolitotripsia percutânea? EDUARDO MEDINA FELICI, ASCBC-RJ1; ANDRÉ LUIZ LIMA DINIZ1; TOMAS ACCIOLY SOUZA1; LUCIANO ALVES FAVORITO1; JOSÉ ANACLETO DUTRA RESENDE JÚNIOR1. A B S T R A C T Objective: to verify the association of success rate of percutaneous lithotripsy, Guy score and size of the stone. Methods: one hundred patients submitted to percutaneous nephrolithotripsy were evaluated. All stones were classified according to Guy Score. Patient free of stone was considered when residual fragments were ≤2mm. Results: according to guy Score, 54% were score 1 (Group 1), 18% score 2 (Group 2), 15% score 3 (Group 3), and 13% score 4 (Group 4). Success was observed in 77.77% in Group 1, 27.77% in group 2, 26.6% in Group 3, and 7.69% in Group 4. In patients with Guy score 1, there was statistical significance of prediction of free stone rate when evaluated according to the size of the stone. Among groups 2, 3 and 4 there was no statistical significance, but it was observed a trend in relation to stone size, the bigger the higher the chance of residual fragments. Conclusion: nephrolithometry by Guy Score and size of the stone are single predictors of success of percutaneous nephrolithotripsy. Stone size may influence success rate of patients with Guy Score 1. Keywords: Kidney Calculi. Nephrolithiasis. Lithotripsy. Propensity Score.

INTRODUCTION

P

METHODS

ercutaneous nephrolithotripsy (PNL) is one of the main methods to treat renal lithiasis, particularly stones with more than 2cm diameter1. Although total fragmentation is expected, it is not always possible, and additional procedures are necessary, in special in staghorn or multiple calix stones2. Size of the stone, calix involvement, calix and pelvic anatomy, and anatomic malformations orient the feasibility of different treatments and impact surgical results3,4. The use of a nephrolithometric validated system may improve stratification and care of patients, and allow for better therapeutic decisions5. However, we believe that this system must take into account stone characteristics, particularly size, for efficient evaluation of PNL. The objective of the present work is to verify the association of success rate of percutaneous nephrolithotripsy, Guy Score and stone size.

This is a retrospective, cross-sectional study approved by the Ethical Committee of Hospital Federal da Lagoa, that reviewed the charts of 137 patients submitted to PNL by one of the authors, from January 2013 to August 2016. All patients signed a free informed consent form and were informed by the risks and benefits of the procedure. We included patients with renal stones bigger than 2cm (higher diameter), or of any size, when previous treatments with extracorporeal lithotripsy (ESWL) or flexible ureteronephroscopy with laser were not possible. Patients with incomplete charts (stone characteristics, results) were not included. All patients received first generation cephalosporin for antibiotic prophylaxis. PNL followed a standardized technique. Initially, an ureteral catheter was introduced endoscopically with the patient in lithotomy position. Next, pa-

1 - Hospital Federal da Lagoa, Urology Department, Rio de Janeiro, RJ, Brazil. Rev Col Bras Cir 2017; 44(6): 619-625


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Felici Can renal stone size and the use of the nephrolithometric system increase the efficacy of predicting the risk of failure of percutaneous nephrolithotripsy?

tient was changed to ventral decubitus and percutaneous access was provided with the aid of a C arch and retrograde pyelography. Path dilation was performed with Amplatz dilators until 30Fr. Nephroscopy was performed by a rigid nephroscope 28F and, using a ultrasonic lithotripter, stone was fragmented, removed or aspirated. In the end of lithotripsy, a double J catheter was inserted, as well as a nephrostomy tube, that was removed after 24 hours. At 30th day of post-operatory, it was obtained a KUB X-ray, and, if there were no residual stones, double J catheter was removed. In the 3rd month, a control computer tomography scan (CT) was obtained to follow up and determination of success rate. If there were residual stones at the X Ray, double J catheter was kept in place, CT scan was performed (<3 months) and the patient was submitted to a new procedure. We considered therapeutic success (free of stones) when residual fragments were lower than 2cm, confirmed by CT. We used the Guy Score nephrolithometric system (GS): GS1 – single stone in meso-renal region or inferior pole in patient with normal anatomy; GS2 – single stone in superior pole, multiple stone in patient with normal anatomy, or single stone in patient with anatomic anomaly; GS3 – multiple stone and anatomic anomaly, diverticulum stone, or partial staghorn stone; GS4 – complete staghorn stone or any stone in patient with spina bifida or spinal trauma1. Aside from GS, we determined stone size using its bigger dimension at CT. After preliminary data analysis, to search for gross errors and outliers identification, and normality test verification for each continuous variable (Kolmogorov-Smirnov), preliminary descriptive statistics was performed to characterize the sample. Non-gaussian distributed variables were submitted to non-parametric statistics. Person chi-square (or Fisher) was used to verify association between categorical variables. Student t test (parametric, considering Levene test for variance equality) and Mann-Whitney or Kruskal-Wallis tests (non-parametric) compared groups in relation to numeric variables. For multi-categorical analysis, we used Multinomial Logistic Regression, and for multivariable analysis we used the Cox regression test. Graphics and statistical analysis were made by the software IBM® SPSS® Statistics Standard Grad

Pack 20 (NY, USA) for Windows® (IBM Corp. Released 2011. IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp.). Statistical results were considered significant when p<0.05 (bicaudal).

RESULTS Thirty seven patients were excluded from the initial 137: 20 had no report of pre-operatory CT, ten no post-operatory CT and seven had not be submitted to post-operatory CT. Among patients included in the study, 40 were male and 60 female. Mean age was 50.8 years and median 52. Among men, mean age was 52.3 years and median 54. Among women, mean age was 49.7 years and median 51 years. Fifty one per cent of stones were located at left side and 49% at the right kidney. Demographic data are presented at table 1. When the greatest diameter of stones in different groups of GS were analyzed, the following means and confidence interval of 95% were found: SG1=20.2mm (18.4 to 22.2 mm); SG2=22.8mm (19.3 to 26.5 mm); SG3=42.7mm (37.5 to 48.5 mm) and SG4=60.8mm (57.5 to 64.3 mm). No differences were found between groups GS1 and GS2 (p=0.204), but when other groups were compared among them, there was statistical significance difference (p<0.001) (Figure 1). According to GS, among 54 patients of group 1, 42 had no residual stone (77.8%), and also six of 18 patients of group 2 (27.8%) and four of 15 patients of group 3 (26.6%); of 13 patients of group 4, only one (7.7%) had no residual stone. There was no statistical difference in the comparison of free stone rate according to gender or stone laterality. However, when success rates were analyzed according to GS and size of stone, it was possible to identify differences (Table 2). When we evaluate the success rate for stratified stones as Guy 1, a higher chance of stone free status was identified, when compared to other Guy groups (Table 3). When we perform a multivariable analysis (Cox Regression) to evaluate the influence of the size of stones in the rate success and of Guy score, in GS1 group, different from other groups, the relative risk

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Felici Can renal stone size and the use of the nephrolithometric system increase the efficacy of predicting the risk of failure of percutaneous nephrolithotripsy?

(RR) was 0.02 for stones up to 2cm, RR of 0.14 for stones 2-2.9cm, RR of 0.34 for stones 3-3.9 cm, RR

621

of 0.68 for stones 4-4.9cm and RR of 1.08 for stones 5cm. In group GS2, the relative risks were 0.13 for sto-

Table 1. Demographic data.

Variables

%

CI 95%

Female

60.0

50.0 – 70.0

Male

40.0

30.0 – 50.0

Left

51.0

41.0 – 61.0

Right

49.0

39.0 – 59.0

Yes

52.0

43.0 – 63.0

No

48.0

37.0 – 57.0

1

54.0

44.0 – 64.0

2

18.0

10.0 – 26.0

3

15.0

8.0 – 22.0

4

13.0

7.0 – 20.0

1 a 1.9 cm

28.0

20.0 – 37.0

2 a 2.9 cm

27.0

18.0 – 37.0

3 a 3.9 cm

13.0

7.0 – 20.0

≥ 4cm

32.0

23.0 – 41.0

Gender

Lateralidade

Sucess rate (stone free)

Guy Score

Size of Stone

CI 95% – Confidence interval.

Table 2. Sucess rate (free of Stone) in different groups.

Stone-free p-Valor Gender (Men x Women) Laterality (Right x Left) Guy Score Size of Stone

Figure 1. Box plot – Size of the stone in each Guy Score group.

0.369* 0.073** 0.000# 0.000#

OR (CI 95%) 0.691 (0.309 – 1.548) 2.607 (0.931 – 4.588) -

OR: Odds Ratio; CI 95%: Confidence interval 95%; * Pearson chi-square test of 2x2 table; ** Fisher chi-square text of 2x2 table; # Pearson chi-square test of table 4x2; Guy Score (Guy-1, Guy-2, Guy-3 and Guy-4); Stone size - group 1 (1 to 1.9cm), group 2 (2 to 2.9cm), group 3 (3 to 3.9cm) and group 4 (≥4cm).

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nes up to 2cm, RR 0.57 for stones 2-2.9cm, RR 0.89 for stones 3-3.9cm, RR 1.27 for stones 4-4.9cm and RR 1.68 for 5cm stones. In GS3, the relative risks were 0.15 for stones up to 2cm, RR 0.80 for stones 2-2.9 cm, RR 1.17 for stones 3-3.9cm, RR of 1.28 for stones

4-4.9cm, RR of 1.40 for stones 5-5.9cm and RR 2,50 for 6cm stones. For group GS4, RR was 0.15 for stones up to 2cm, RR 0.80 for stones 2-2.9cm, RR 1.27 for stones 3.3.9cm, RR 1.72 for stones 4-4.9cm and RR 1.72 for 5cm stones (Figure 2).

Table 3. Success rate (free of stones) comparing Guy Score group 1 to other Guy score groups.

Free of Stone

Guy Score vs.

p-Valor

OR (CI 95%)

Guy Score 2

< 0.001

8.400 (3.323 – 21.331)

Guy Score 3

< 0.001

10.500 (3.765 – 29.282)

Guy Score 4

< 0.001

42.000 (5.781 – 305.158)

OR- Odds Ratio; CI 95%- Confidence interval 95%; Multinodal Logistic Regression.

DISCUSSION When we analyzed the influence of the stone size and success rate (free of stones) in each GS and among them, we observed that the higher the size of the stone, the higher the chance of the patient present residual stones. GS1 patients with stones bigger than 5cm had a higher chance of residual stones. In GS2, GS3 and GS4 patients, the risk of residual stones was higher for stones bigger than 4cm, 3cm and 3cm, respectively. Percutaneous access for the treatment of kidney stones was proposed 30 years ago by Fernstrom and Johansson6. With the improvement of the technique, nowadays, PNL replaced open surgery in the treatment of complex renal stones in many facilities7. Choice of surgical technique is based on the stone characteristics in image exams, particularly CT. Usually, stones bigger than 2cm and >1000UH (Hounsfield units) are candidate to percutaneous treatment8. Contrary to classic indications, stones lower than 2cm and with difficult access, or complex staghorn stones may also be treated by this technique, as observed in our study. Several methods of nefrolithometry were proposed to classify stones according to nature and position. The first was proposed by Thomas et al.1 using the

Guy Score. Smith et al.9 described the nephrolithometric nomogram CROES (Clinical Research Office of the Endourological Society). Okhunov et al.10 developed the score system S.T.O.N.E. Literature presents several comparisons of nephrolithometric methods, but there are no evidences with statistical significance that indicate the systematic use of a single one. Withington et al.11 made a literature review of these tools in the evaluation of stone complexities and success rates, in order to evaluate any evidences that favored one of them. This review showed no preference of a single system. However, evidences showed that GS was slightly superior. Labadie et al.12 compared each system in the same cohort to determine which was more predictive of surgical success. They concluded that all classification systems could equally predict stone-free rate. Guy and S.T.O.N.E nephrolithometries estimated better blood loss and hospitalization time. Vicentini et al.13 published a study that affirmed that GS, based on CT scans, predicted with higher accuracy success and complications rates after PNL. Since it is very simple to apply, we chose GS nephrolithometry score associated to size of stones to analyze our cohort. In Vicentini et al.13 study, the greatest stone diameters were different among groups, statistically significant (SG1=21.4mm; SG2=26.5mm; SG3=31.4mm

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Figure 2. Cox Regression – Residual stone risk based on the size of stones (dependent variable) according to co-variable ‘free of stones” and of the following variables “state/event”: A) Guy 1 versus [Guy 2 + Guy 3 + Guy 4]; B) Guy 2 versus [Guy 1 + Guy 3 + Guy 4]; C) Guy 3 versus [Guy 1 + Guy 2 + Guy 4]; D) Guy 4 versus [Guy 1 + Guy 2 + Guy 3].

and SG4=50.5mm). In our work, there were differences only between GS1 and GS2 groups (p=0.204). When patients were divided in groups according do GS and biggest diameter, the stone-free rate was evaluated, and stratified GS1 group was an independent predictive factor for stone-free rate (p<0.001). We also observed that the smaller the stone, the higher the chance of success (p<0.001). When patients were classified as GS2, GS3 and GS4, there was a higher risk of unsuccess (with residual stones) for stones bigger than 4cm, 3m and 3 cm, respectively. But since our sample in these groups was small, this information should be cautiously analyzed. Alobaidy et al.14 observed that, with the increase

of stone size and complexity, the rate of stone-free patients lowered, but did not correlate this finding to Guy parameters. Aside from predicting stone-free rate, GS can predict with good accuracy the rate of complications. Vicentini et al.13 reviewed 155 PNL and showed statistical significance of Guy score and blood transfusion rate and surgery time. Bozkurt et al.15 also identified a statistical significant relation between GS and post-operatory complication rate. In 2008, Tefekli et al.16 evaluated 811 patients and proposed an adaptation of Modified Clavien score17 for analysis of PNL complications. They divided the severity of complications based on stone complexity and

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Felici Can renal stone size and the use of the nephrolithometric system increase the efficacy of predicting the risk of failure of percutaneous nephrolithotripsy?

did not find any significant relation. In our populational analysis, we identified eight major complications (Modified Clavien grades 3a to 4b)17, but without statistical significance in relation to GS. Absence of complications grades 1 and 2 reflects a bias inherent to retrospective analysis, since they are minor complications, self-limited and with low impact on clinical success, and not well reported at the charts. In our sample, no patient received blood transfusion. Tefekli et al.16 reported that only 2.8% of patients had post-operatory fever, relating this to the use of antibiotic prophylaxis in all their patients, as we did in our study. Although a cross-sectional retrospective study has some limitations, those were minimized in ours by standardization of data collection and objective definition of end-point. Other limiting factors included those described in the exclusion criteria. Also, we point out

that our data were collected in only one center, with an urological residence program, where young surgeons are trained by professionals with excellency in PNL18. In the present study, we observed that stone size and Guy Score are single predictive factors for success (stone-free). We also observed that stone size may influence success rate within each GS group, in special GS1. For other Guy groups, there were no statistical significant differences, but a tendency of higher chance of stone-free status, the smaller the stone size. This tendency may be confirmed in future studies increasing the size of the sample. A validated simple nephrometric system that takes into consideration the stone size, easily used, reproductible, with good correlation to success rate (stone-free) and PNL complication rate, will improve pre-operatory counseling of patients and resident capacitation.

R E S U M O Objetivo: verificar a associação entre taxa de sucesso de nefrolitotripsia percutânea, escore de Guy e tamanho do cálculo. Métodos: foram avaliados 100 pacientes submetidos à nefrolitotripsia percutânea. Todos os cálculos foram classificados de acordo com o escore de Guy. Consideramos o paciente livre de cálculos quando os fragmentos residuais fossem menores ou iguais a 2mm. Resultados: de acordo com o escore de Guy, 54% tinham escore 1 (Grupo 1), 18% escore 2 (Grupo 2), 15% escore 3 (Grupo 3) e 13% escore 4 (Grupo 4) . Houve resolução de 77,77% no grupo 1, de 27,77% no grupo 2, de 26,6% no grupo 3 e de 7,69% no grupo 4. Houve significância estatística para predição de taxa livre de cálculos entre os pacientes com escore de Guy 1 quando avaliados de acordo com o tamanho do cálculo. Entre os grupos 2, 3 e 4 não houve significância estatística, porém observamos tendência de que quanto maior o tamanho do cálculo, maior a chance de cálculo residual. Conclusão: a nefrolitometria pelo Escore de Guy e o tamanho do cálculo são preditores isolados para avaliação de sucesso da nefrolitotripsia percutânea. O tamanho do cálculo pode influenciar a taxa de sucesso de pacientes com Escore de Guy 1. Descritores: Cálculos Renais. Nefrolitíase. Litotripsia. Pontuação de Propensão.

REFERENCES 1.

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3.

4.

Thomas K, Smith NC, Hegarty N, Glass JM. The Guy’s stone score--grading the complexity of percutaneous nephrolithotomy procedures. Urology. 2011;78(2):27781. Sinha RK, Mukherjee S, Jindal T, Sharma PK, Saha B, Mitra N, et al. Evaluation of stone-free rate using Guy’s Stone Score and assessment of complications using modified Clavien grading system for percutaneous nephro-lithotomy. Urolithiasis. 2015;43(4):349-53. Binbay M, Akman T, Ozgor F, Yazici O, Sari E, Erbin A, et al. Does pelvicaliceal system anatomy affect success of percutaneous nephrolithotomy? Urology. 2011;78(4):733-7.

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Osther PJ, Razvi H, Liatsikos E, Averch T, Crisci A, Garcia JL, et al. Percutaneous nephrolithotomy among patients with renal anomalies: patient characteristics and outcomes; a subgroup analysis of the clinical research office of the endourological society global percutaneous nephrolithotomy study. J Endourol. 2011;25(10):1627-32. Vernez SL, Okhunov Z, Motamedinia P, Bird V, Okeke Z, Smith A. Nephrolithometric Scoring Systems to Predict Outcomes of Percutaneous Nephrolithotomy. Rev Urol. 2016;18(1):15-27. Fernström I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. Matlaga BR, Assimos DG. Changing indications of open

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8. 9.

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stone surgery. Urology. 2002;59(4):490-3; discussion 493-4. Wen CC, Nakada SY. Treatment selection and outcomes: renal calculi. Urol Clin North Am. 2007;34(3):409-19. Smith A, Averch TD, Shahrour K, Opondo D, Daels FP, Labate G, Turna B, de la Rosette JJ; CROES PCNL Study Group. A nephrolithometric nomogram to predict treatment success of percutaneous nephrolithotomy. J Urol. 2013;190(1):149-56. Okhunov Z, Friedlander JI, George AK, Duty BD, Moreira DM, Srinivasan AK, et al. S.T.O.N.E. nephrolithometry: novel surgical classification system for kidney calculi. Urology. 2013;81(6):1154-9. Withington J, Armitage J, Finch W, Wiseman O, Glass J, Burgess N. Assessment of Stone Complexity for PCNL: a systematic review of the literature, how best can we Record Stone Complexity in PCNL? J Endourol. 2016;30(1):13-23. Labadie K, Okhunov Z, Akhavein A, Moreira DM, Moreno-Palacios J, Del Junco M, et al. Evaluation and comparison of urolithiasis scoring systems used in percutaneous kidney stone surgery. J Urol. 2015;193(1):154-9. Vicentini FC, Marchini GS, Mazzucchi E, Claro JF, Srougi M. Utility of the Guy’s stone score based on computed tomographic scan findings for predicting percutaneous nephrolithotomy outcomes. Urology. 2014;83(6):1248-53. Alobaidy A, Al-Naimi A, Assadiq K, Alkhafaji H, AlAnsari A, Shokeir AA. Percutaneous nephrolithotomy:

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critical analysis of unfavorable results. Can J Urol. 2011;18(1):5542-7. Bozkurt IH, Aydogdu O, Yonguc T, Yarimoglu S, Sen V, Gunlusoy B, et al. Comparison of Guy and Clinical Research Office of the Endourological Society Nephrolithometry Scoring Systems for Predicting StoneFree Status and Complication Rates After Percutaneous Nephrolithotomy: A Single Center Study with 437 Cases. J Endourol. 2015;29(9):1006-10. Tefekli A, Ali Karadag M, Tepeler K, Sari E, Berberoglu Y, Baykal M, et al. Classification of percutaneous nephrolithotomy complications using the modified Clavien grading system: looking for a standard. Eur Urol. 2008;53(1):184-90. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205-13. De la Rosette JJ, Laguna MP, Rassweiler JJ, Conort P. Training in percutaneous nephrolithotomy--a critical review. Eur Urol. 2008;54(5):994-1001.

Received in: 06/08/2017 Accepted for publication: 21/09/2017 Conflict of interest: none. Source of funding: none. Mailing address: José Anacleto Dutra Resende Júnior E-mail: joseanacletojunior@gmail.com

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Original Article

DOI: 10.1590/0100-69912017006015

Ruling out intra-abdominal injuries in blunt trauma patients using clinical criteria and abdominal ultrasound Exclusão de lesões intra-abdominais em vítimas de trauma fechado através de variáveis clínicas e ultrassom abdominal completo FLÁVIA HELENA BARBOSA MOURA, ASCBC-SP1; JOSÉ GUSTAVO PARREIRA, TCBC-SP2,3; THIARA MATTOS4; GIOVANNA ZUCCHINI RONDINI4; CRISTIANO BELOW4; JACQUELINE ARANTES G. PERLINGEIRO, TCBC-SP2,3; SILVIA CRISTINE SOLDÁ, TCBC-SP2,3; JOSÉ CESAR ASSEF, TCBC-SP2,3. A B S T R A C T Objective: to identify victims of blunt abdominal trauma in which intra-abdominal injuries can be excluded by clinical criteria and by complete abdominal ultrasonography. Methods: retrospective analysis of victims of blunt trauma in which the following clinical variables were analyzed: hemodynamic stability, normal neurologic exam at admission, normal physical exam of the chest at admission, normal abdomen and pelvis physical exam at admission and absence of distracting lesions (Abbreviated Injury Scale >2 at skull, thorax and/or extremities). The ultrasound results were then studied in the group of patients with all clinical variables evaluated. Results: we studied 5536 victims of blunt trauma. Intra-abdominal lesions with AIS>1 were identified in 144 (2.6%); in patients with hemodynamic stability they were present in 86 (2%); in those with hemodynamic stability and normal neurological exam at admission in 50 (1.8%); in patients with hemodynamic stability and normal neurological and chest physical exam at admission, in 39 (1.5%); in those with hemodynamic stability, normal neurological, chest, abdominal and pelvic physical exam at admission, in 12 (0.5%); in patients with hemodynamic stability, normal neurological, chest, abdominal and pelvic physical exam at admission, and absence of distracting lesions, only two (0.1%) had intra-abdominal lesions. Among those with all clinical variables, 693 had normal total abdominal ultrasound, and, within this group, there were no identified intra-abdominal lesions. Conclusion: when all clinical criteria and total abdominal ultrasound are associated, it is possible to identify a group of victims of blunt trauma with low chance of significant intra-abdominal lesions. Keywords: Abdominal Injuries. Delayed Diagnosis. Diagnosis. Ultrasonography. External Causes. Multiple Trauma.

INTRODUCTION

I

n Brazil, in 2015, more than 152,000 people lost their lives due to external causes1. However, this is just one of the aspects of this problem2. During acute phase, costs of medical care, hospitalization, exams and treatment must also be taken into account. It is expected that, in a broad sample of victims with blunt trauma, 2% to 3% have intra-abdominal lesions (IAL)3. Even in asymptomatic patients with normal physical exam, it is possible to find potentially lethal intra-abdominal lesions. This is one of the reasons why we consider nondiagnosed intra-abdominal lesions a frequent cause of “preventable” death in trauma patients. Therefore, image exams had been progressively introduced in the evaluation of victims of blunt trauma.

At present, FAST (Focused Assessment Sonography for Trauma) is one of the first methods that can be used. This method uses ultrasound to detect free liquid at the abdominal cavity. However, a negative exam does not exclude IAL. Also, total abdominal ultrasound, aside from free liquid, detects visceral lesions. It is performed by radiologists, since the learning curve is much longer. Total US presents, as main advantages, its low cost, availability, portability, the chance to reexam several times the same patient, and the lack of use of ionizing radiation or contrast. It may also present false-negative results, since it depends on the examiner and not always detects minor bleeding or intraperitoneal lesions4,5. Its result may be compromised by gas interposition, obesity or empty bladder. Literature data show that US may fail in up to 10%

1 - Irmandade da Santa Casa de Misericórdia de São Paulo, Department of Surgery, São Paulo, SP, Brazil. 2 - Irmandade da Santa Casa de Misericórdia de São Paulo, Emergency Department, São Paulo, SP, Brazil. 3 - Faculty of Medical Sciences of Santa Casa de São Paulo, Department of Surgery, São Paulo, SP, Brazil. 4 - Faculty of Medical Sciences of Santa Casa de São Paulo, Medical School, São Paulo, SP, Brazil. Rev Col Bras Cir 2017; 44(6): 626-632


Moura Ruling out intra-abdominal injuries in blunt trauma patients using clinical criteria and abdominal ultrasound

patients6,7. Computer tomography (CT) has a sensitivity of 99% in some studies and is considered a better accurate method to diagnose traumatic intra-abdominal lesions, but also with disadvantages and limitations. CT not always detects pancreatic and intestinal lesions8. Also, when compared to abdominal ultrasound, is less available, with higher cost, with no portability and with the risks of ionizing radiation and use of iodinated contrast9-12. Therefore, the attending physician must know how to use these image methods optimally, balancing their advantages and disadvantages. In a large trauma center, the optimized use of US saves costs of more expensive exams and non-therapeutic procedures. We hypothesize that the association of clinical variables and total abdominal ultrasound may be used to exclude intra-abdominal lesions in victims of blunt trauma, lowering the need of abdominal Ct. Therefore, the objective of our study is to evaluate the association of several clinical variables and abdominal ultrasound to exclude intra-abdominal lesions in victims of blunt trauma.

METHODS This study was approved by the Research Ethical Committee of Irmandade da Santa Casa de São Paulo, # 59542816.2.0000.5479. We performed a retrospective analysis of information at the data bank of the Emergency Department, that were prospectively collected using standardized protocols of quality control, from 2008 to 2010. In the study, we included victims of blunt trauma with more than 14 years old. We revised identification, trauma mechanism, general condition at admission, exams, lesions, treatment and complications. Severity of trauma and lesions were stratified by the following scores: Coma Glasgow Scale (CGS), Revised Trauma Score (RTS), Abbreviated Injury Scale (AIS), Organ Injury Scale (OIS) and Injury Severity Score (ISS)13. The routine protocol of objective evaluation of abdomen of victims of blunt trauma in our Emergency Department includes initial physical exam, image and laboratory exams. Image exams include FAST,

627

US and CT; the latter is selectively obtained depending on the risk evaluation of abdominal lesion of the attending physician. Laboratory tests include white cells count, serum amylase, arterial blood gases, according to severity of trauma. Leukocytosis, hyperamylasemia and metabolic acidosis (base deficit inferior to -6mEq/L) suggest the presence of lesions eventually not identified by the image exams. In our study, we selected clinical variables evaluated at admission: hemodynamic stability (HS), normal neurological exam at admission (NNEx), normal chest physical exam (NTEx), normal abdominal and pelvic physical exam (NAPEx) and absence of distracting lesions (ADL). HS was considered when SBP>100mmHg and CR<100bpm. NNEx was considered when patient was conscious, oriented, Coma Glasgow Scale 15. NTEx was considered when physical exam showed no signs of thoracic trauma and patients had no symptoms of thoracic lesions. NAPEx was considered when patient was asymptomatic and abdominal and pelvic physical exams showed no pain or signs of local trauma (bruises, escorting, hematomas). Distracting lesions were those AIS>2 at skull, thorax or extremities. Those criteria were progressively overlapped to select the group with the smallest possibility to present IAL with AIS>1. Those variables are easily identified during initial evaluation of trauma patients, and are useful tools for decision making. They were determined by the most senior surgical resident (R3/R4) along with attending physicians. After that, we analyzed the US results in the group of patients with all clinical evaluated variables. We also performed a comparison of frequency of IAL with AIS>1 among patients with or without evaluated variables, using the chi-square test, considering statistically significant when p<0.05. We calculated the Odds Ratio and 95% confidence interval for absence of intra-abdominal lesions according to clinical variables. The above mentioned variables were included in a logistic regression by the “Enter” method, to identify a predictive model of “absence” of intra-abdominal lesions. We calculated the area under the curve ROC (Receiver Operating Characteristic) to estimate the ac-

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628

curacy of the model obtained by logistic regression.

RESULTS During the studied period, 5536 patients victims of blunt abdominal trauma were consulted. IAL were identified in 172 patients (3.1%). Of patients with abdominal AIS>1, there were 144 (2.6%) patients with IAL, mainly parenchymal organs (Table 1).

Odds Ratio for absence of IAL with AIS>1 was normal abdominal exam: 12.1 (8.9 to 16.6). The created predictive model by logistic regression (Table 4) reached an area under the curve (AUC) of 0.898 (accuracy of 89.8%) (Figure 2).

Table 2. Association of analyzed variables and frequency of intra-abdominal lesions.

Variable

Number of patients

IAL frequency (%)

Table 1. AIS>1 intra-abdominal lesions in 144 patients victims of blunt trauma.

HS

4290

86 (2.0)

Inflicted organ

Number (%)

NNEx

3419

78 (2.3)

Spleen

54 (37.5)

NTEx

4998

117 (2,3)

Liver

50 (34.7)

NAPEx

4945

73 (1.5)

Kidneys

21 (14.5)

ADL

4431

64 (1.4)

Small intestine

10 (6.9)

HS + NNEx

2834

50 (1.8)

Colon

1 (0.7)

Bladder

8 (5.5)

HS + NNEx + NTEx

2577

39 (1.5)

HS + NNEx + NTEx + NAPEx

2356

12 (0.5)

HS + NNEx + NTEx + NAPEx + ADL

2031

4 (0.2)

Total

144 (100.0)

Considering only the 4290 patients with HS, IAB were present in 86 (2%). In 2834 patients with HS and NNEx, IAL were diagnosed in 50 (1.8%). In 2577 patients with HS, NNEX and NTEx , IAL were present in 39 (1.5%). Of 2356 patients with HS, NNEx, NTEx and NAPEx, IAL were found in 12 (0.5%). Of 2031 patients with HS, NNEx, NTEx, NAPEx and ADL, only two had IAL (two splenic lesions: one not treated by surgery and another submitted to splenectomy) (Table 2). In the group with all clinical variables, 693 had normal US, and, in this group, there were no IAL. In patients with abdominal AIS>1 submitted to US according to our protocol, US reached 94.6% of positivity, identifying 71 of 75 possible IAL (Table 3). At figure 1, we observed the comparison of frequency of IAL with AIS>1 among patients with and without studied clinical variables. All comparisons were statistically significant, p<0.001. The highest

HS: hemodynamic stability; NNEx: normal neurological exam at admission; NTEX: normal thorax exam at admission; NAPEx: normal abdominal and pelvic exams at admission; ADL: absence of distracting lesions.

Table 3. Abdominal ultrasound positivity to intra-abdominal lesions (AIS>1).

Inflicted organ (absolute number)

total US (performed)

Positive US n (%)

Liver (50)

28

27 (96.4)

Spleen (54)

33

32 (96.9)

Kidney (21)

9

8 (88.9)

Small intestine (10)

3

2 (66.7)

Bladder (8)

2

2 (100.0)

Total

75

71 (94.6)

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Table 4. Logistic regression by the “Enter” method of analyzed variables.

Variables in the Equation Etep1a

B

S.E.

Wald

df

Sig.

Exp(B)

NNEx (1)

.122

.190

.412

1

.521

1.130

HS (1)

.918

.192

22.923

1

.000

2.504

NTEx (1)

.495

.208

5.690

1

.017

1.641

NAPEx (1)

2.436

.183

176.290

1

.000

11.427

ADL (1)

1.809

.190

90.543

1

.000

6.107

Constant

5.235

.183

814.404

1

.000

.005

Variables entered on step 1: NNEx: normal neurological exam at admission; HS: hemodynamic stability; NTEx: normal chest exam at admission; NAPEx: normal abdominal and pelvic exam at admission; ADL: absence of distractive lesions.

DISCUSSION

Figure 1. Comparison of frequency of IAL>1 among groups. O.R.: Odds ratio. 95% Confidence Interval.

Figure 2. ROC curve for the model with clinical variables. AUC: area under the curve ROC.

Trauma is a disease where it is observed exchange of energy between external environment and human body, that may cause lesions in all organism. It is a World epidemics. Trauma disease is the major cause of loss of productive years, since it afflicts mainly young people in most productive years2. Early identification and treatment of lesions assure better prognosis. Our data confirm low frequency of intra-abdominal lesions in a cohort of victims of blunt trauma (2.6%). However, the analysis of such lesions show that they could add morbidity and mortality if not identified on time. Many studies tried to stablish guidelines to exclude intra-abdominal lesions using clinical criteria3,12,14-18. These clinical markers were capable to indicate the presence of intra-abdominal lesions, but with low performance to exclude them. In clinical practice, “exclusion” of IAL is a very frequent problem. This is the reason why image methods are used to complement correct abdominal evaluation in victims of blunt trauma. CT is the gold-standard exam to identify possible IAL, with up to 99% of sensitivity. However, it has some disadvantages: higher cost and long hospitalization time. In centers with high daily number of patients, the use of CT must be efficient, without a significant number of negative exams during evaluation of victims of blunt trauma; also, it exposes patients to ionizing radiation, and present risks inherent to the use of intravenous contrast. At present, the best protocol

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Moura Ruling out intra-abdominal injuries in blunt trauma patients using clinical criteria and abdominal ultrasound

for selective use of CT based on clinical, laboratorial and image methods (such as FAST and US)3,9-12 has not been determined. Among these, FAST is the method with lower sensitivity. However, it is the only available resource in the trauma room, important in hemodynamically unstable patients. Usually, FAST does not identify 25% of IAL, and its accuracy varies from 60 to 80%3,19. US has a sensitivity of up to 90% if performed by a talented radiologist. When we associate US to clinical variables, sensitivity reach that of CT, as shown by some studies3,5,6,15,20. Our objective met this necessity. We believe that the use of clinical variables and associated total abdominal US may present an adequate accuracy. When we chose those clinical variables, we observed practicality. We selected those that could be evaluated at trauma room without the need of complex resources. During initial evaluation, we observe hemodynamics status, and perform thoracic, abdominal, neurological and extremities exams. In front of doubtful evaluation of thorax or pelvis exams, X-rays may be ordered. Therefore, during initial consultation, it is possible to identify the following variables: hemodynamic stability (HS), normal neurological exam at admission (NNEx), normal chest exam at admission (NTEx), normal abdominal and pelvic physical exam at admission (NAPEx) and absence of distracting lesions (ADL). The choice of these variables took into account previous studies that associated the presence of intra-abdominal lesions to hemodynamic stability, thoracic lesions, as well as pelvic, extremities and intracranial lesions12. It is important to highlight that abdominal physical exam may be normal, even in patients with potentially lethal intra-abdominal lesions. This can be explained by the presence of associated cranial-encephalic trauma (CET), distracting lesions or use of sedatives at admission (for example, for oral-tracheal intubation) that can misguide clinical exam18,21. Therefore, the doubt to perform image exams is observed in patients with normal abdominal exam but with other indicators of abdominal lesion. Sharples and Brohi22, in 2016, revised literature and identified seven important studies. Sensitivity of several tools to detect intra-abdominal lesions varied from 86% to 100%. In our study, the sequential addi-

tion of studied variables (HS + NNEx + NTEx + NAPEx + ADL) resulted in a frequency of 0.1% of abdominal lesions. If associated to US, all lesions with AIS>1 would be identified (100% sensitivity). Holmes et al.23, in 2009, evaluated a model that included clinical data (Glasgow Coma Scale <14, pain at costal arches, abdominal pain and femur fracture) and laboratory tests such as hematocrit and urine exam. This study, that included 1595 patients during validation phase, presented a tool with negative predictive value of 98.6%. In our analysis, we chose not to include laboratory exams, that would add a significant time to the process. Even without these exams, we had a significant accuracy. Nishijima et al.24, in 2012, add to clinical and laboratory exams the results of bedside ultrasound. These authors reported that the presence of intra-abdominal free liquid was the best marker of lesion, overcoming clinical data and laboratory exams. However, the absence of liquid did not exclude the presence of intra-abdominal lesions. This study reinforces the idea to associate clinical data and image exams, such as in our study and of other authors15. Chardoli et al.25, in 2017 used the absence of clinical markers, ultrasound (FAST) and laboratory alterations in intra-abdominal lesions as a criteria for hospital discharge of patients victims of blunt trauma without CT. These authors interviewed by phone these patients after one week and none of 158 patients had symptoms of undiagnosed abdominal lesions. Our data also favor the identification of a subgroup of victims of blunt trauma with minimal chance of intra-abdominal lesions that could be discharged without CT scan. This would optimize the available resources of crowded emergency centers without compromising patient safety. There are data that show that significant IAL are apparent up to nine hours after trauma26. Maybe this variable can be included in future studies in order to also limit the use of abdominal ultrasound in these patients. Although with interesting results, we must emphasize some limitations of our study. It is a retrospective study, and there are nuances in the definition of the studied variables. For example, in elderly people, hemodynamic stability may be interpreted differently.

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There may be also possible disagreement of a particular variable by the attending physicians. One of the major limitations is the lack of a “true” negative result, that is, our protocol may have not identified lesions and we were not informed of new admissions for that reason. Since our team is responsible for daily follow up of all

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victims of trauma, probably we would be aware of this fact. Also, other studies are needed, particularly prospective, to validate our data. Our final message is that it is possible to associate clinical variables and US to exclude IAL with AIS>1 in victims of blunt trauma.

R E S U M O Objetivo: identificar vítimas de trauma fechado de abdome nas quais as lesões intra-abdominais possam ser excluídas por critérios clínicos e por ultrassonografia abdominal completa. Métodos: análise retrospectiva de vítimas de trauma fechado em que se analisou as seguintes variáveis clínicas: estabilidade hemodinâmica, exame neurológico normal à admissão, exame físico do tórax, do abdome e da pelve normais à admissão e ausência de lesões distrativas (Abbreviated Injury Scale >2 em crânio, tórax e/ou extremidades). Em seguida estudou-se o resultado da ultrassonografia no grupo de pacientes com todas as variáveis clínicas avaliadas. Resultados: estudamos 5536 vítimas de trauma fechado. Lesões intra-abdominais com AIS>1 foram identificadas em 144 (2,6%) casos; em pacientes com estabilidade hemodinâmica, estavam presentes em 86 (2%); naqueles com estabilidade hemodinâmica e exame neurológico normal à admissão em 50 (1,8%); nos casos com estabilidade hemodinâmica, exame neurológico e do tórax normais à admissão em 39 (1,5%); em pacientes com estabilidade hemodinâmica e com exame neurológico, do tórax, do abdome e da pelve normais em 12 (0,5%); naqueles com estabilidade hemodinâmica e com exame neurológico, do tórax, do abdome e da pelve normais e ausência de lesões distrativas, em apenas dois (0,1%) pacientes. Nos pacientes com todas as variáveis clínicas, 693 apresentavam ultrassonografia abdominal completa normal e, neste grupo, não foram identificadas lesões intra-abdominais posteriormente. Conclusão: pela somatória de critérios clínicos e ultrassonografia abdominal completa, é possível identificar um grupo de vítimas de trauma fechado com baixa chance de apresentar lesões intra-abdominais significativas. Descritores: Traumatismos Abdominais. Diagnóstico Tardio. Diagnóstico. Ultrassonografia. Causas Externas. Traumatismo Múltiplo.

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Brasil. Ministério da Saúde. DATASUS. Indicadores de mortalidade: óbitos por causa externa [Internet]. Brasília (DF): Ministério da Saúde; 2015 [citado 2017 Aug 2017]. Disponível em: http://tabnet.datasus.gov. br/cgi/tabcgi.exe?sim/cnv/ext10uf.def Reichenheim ME, de Souza ER, Moraes CL, de Mello Jorge MH, da Silva CM, de Souza Minayo MC. Violence and injuries in Brazil: the effect, progress made, and challenges ahead. Lancet. 2011;377(9781):1962-75. Farrath S, Parreira JG, Olliari CB, Silva MA, Perlingeiro JA, Soldá SC, et al. Identifying severe abdominal injuries during the initial assessment in blunt trauma patients. Rev Col Bras Cir. 2013;40(4):305-11. Stengel D, Rademacher G, Ekkernkamp A, Güthoff C, Mutze S. Emergency ultrasound-based algorithms for diagnosing blunt abdominal trauma. Cochrane Database Syst Rev. 2015;(9):CD004446. Feyzi A, Rad MP, Ahanchi N, Firoozabadi J. Diagnostic accuracy of ultrasonography in detection of blunt abdominal trauma and comparison of early and late ultrasonography 24 hours after trauma. Pak J Med Sci.

2015;31(4):980-3. 6. Brown MA, Sirlin CB, Hoyt DB, Casola G. Screening ultrasound in blunt abdominal trauma. J Intensive Care Med. 2003;18(5):253-60. 7. Nural MS, Yardan T, Güven H, Baydin A, Bayrak IK, Kati C. Diagnostic value of ultrasonography in the evaluation of blunt abdominal trauma. Diagn Interv Radiol. 2005;11(1):41-4. 8. Melamud K, LeBedis CA, Soto JA. Imaging of Pancreatic and Duodenal Trauma. Radiol Clin North Am. 2015;53(4):757-71, viii. 9. Colling KP, Irwin ED, Byrnes MC, Reicks P, Dellich WA, Reicks K, et al. Computed tomography scans with intravenous contrast: low incidence of contrast-induced nephropathy in blunt trauma patients. J Trauma Acute Care Surg. 2014;77(2):226-30. 10. James MK, Schubl SD, Francois MP, Doughlin GK, Lee SW. Introduction of a pan-scan protocol for blunt trauma activations: what are the consequences? Am J Emerg Med. 2017;35(1):13-19. 11. Radwan MM, Abu-Zidan FM. Focussed Assesment Sonograph Trauma (FAST) and CT scan in blunt abdominal trauma: surgeon’s perspective. Afr Health

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Sci. 2006;6(3):187-90. Farrath S, Parreira JG, Perlingeiro JA, Solda SC, Assef JC. Predictors of abdominal injuries in blunt trauma. Rev Col Bras Cir. 2012;39(4):295-300. Pereira Jr GA, Scarpelini S, Basile-Filho A, Andrade JI. Índices de trauma. Medicina, Ribeirão Preto. 1999;32(3):237-50. Deunk J, Brink M, Dekker HM, Kool DR, van Kuijk C, Blickman JG, et al. Routine versus selective computed tomography of the abdomen, pelvis, and lumbar spine in blunt trauma: a prospective evaluation. J Trauma. 2009;66(4):1108-17. Dehqanzada ZA, Meisinger Q, Doucet J, Smith A, Casola G, Coimbra R. Complete ultrasonography of trauma in screening blunt abdominal trauma patients is equivalent to computed tomographic scanning while reducing radiation exposure and cost. J Trauma Acute Care Surg. 2015;79(2):199-205. Mackersie RC, Tiwary AD, Shackford SR, Hoyt DB. Intraabdominal injury following blunt trauma. Identifying the high-risk patient using objective risk factors. Arch Surg.1989;124(7):809-13. Deunk J, Brink M, Dekker HM, Kool DR, Blickman JG, van Vugt AB, et al. Predictors for the selection of patients for abdominal CT after blunt trauma: a proposal for a diagnostic algorithm. Ann Surg. 2010;251(3):512-20. Karamercan A, Yilmaz TU, Karamercan MA, Aytaç B. Blunt abdominal trauma: evaluation of diagnostic options and surgical outcomes. Ulus Travma Acil Cerrahi Derg. 2008;14(3):205-10. Richards JR, McGahan JP. Focused Assessment with Sonography in Trauma (FAST) in 2017: what radiologists can learn. Radiology. 2017;283(1):30-48. Brown MA, Casola G, Sirlin CB, Patel NY, Hoyt DB. Blunt

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abdominal trauma: screening us in 2,693 patients. Radiology. 2001;218(2):352-8. Parreira JG, Malpaga JMD, Olliari CB, Perlingeiro JAG, Soldá SC, Assef JC. Predictors of “occult” intraabdominal injuries in blunt trauma patients. Rev Col Bras Cir. 2015;42(5):311-7. Sharples A, Brohi K. Can clinical prediction tools predict the need for computed tomography in blunt abdominal? A systematic review. Injury. 2016;47(8):1811-8. Holmes JF, Wisner DH, McGahan JP, Mower WR, Kuppermann N. Clinical prediction rules for identifying adults at very low risk for intra-abdominal injuries after blunt trauma. Ann Emerg Med. 2009;54(4):575-84. Nishijima DK, Simel DL, Wisner DH, Holmes JF. Does this adult patient have a blunt intra-abdominal injury? JAMA. 2012;307(14):1517-27. Chardoli M, Rezvani S, Mansouri P, Naderi K, Vafaei A, Khorasanizadeh M, et al. Is it safe to discharge blunt abdominal trauma patients with normal initial findings? Acta Chir Belg. 2017;117(4):211-215. Jones EL, Stovall RT, Jones TS, Bensard DD, Burlew CC, Johnson JL, et al. Intra-abdominal injury following blunt trauma becomes clinically apparent within 9 hours. J Trauma Acute Care Surg. 2014;76(4):1020-3.

Received in: 15/08/2017 Accepted for publication: 28/09/2017 Conflict of interest: none. Source of funding: none. Mailing address: José Gustavo Parreira E-mail: jgparreira@uol.com.br / mcmassef@uol.com.br

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Review Article

DOI: 10.1590/0100-69912017006003

ACERTO guidelines of perioperative nutritional interventions in elective general surgery Diretriz ACERTO de intervenções nutricionais no perioperatório em cirurgia geral eletiva JOSÉ EDUARDO DE-AGUILAR-NASCIMENTO, TCBC-MT1,2; ALBERTO BICUDO SALOMÃO, ACBC-MT1; DAN LINETZKY WAITZBERG, TCBC-SP3; DIANA BORGES DOCK-NASCIMENTO1; MARIA ISABEL T. D. CORREA, TCBC-MG4; ANTONIO CARLOS L. CAMPOS, TCBC-PR5; PAULO ROBERTO CORSI, TCBC-SP6; PEDRO EDER PORTARI FILHO, TCBC-RJ7; CERVANTES CAPOROSSI, TCBC-MT1; COMISSÃO DE CUIDADOS PERIOPERATÓRIOS DO COLÉGIO BRASILEIRO DE CIRURGIÕES. SOCIEDADE BRASILEIRA DE NUTRIÇÃO PARENTERAL E ENTERAL (SBNPE). A B S T R A C T Objective: to present recommendations based on the ACERTO Project (Acceleration of Total Post-Operative Recovery) and supported by evidence related to perioperative nutritional care in General Surgery elective procedures. Methods: review of relevant literature from 2006 to 2016, based on a search conducted in the main databases, with the purpose of answering guiding questions previously formulated by specialists, within each theme of this guideline. We preferably used randomized controlled trials, systematic reviews and meta-analyzes but also selected some cohort studies. We contextualized each recommendation-guiding question to determine the quality of the evidence and the strength of this recommendation (GRADE). This material was sent to authors using an open online questionnaire. After receiving the answers, we formalized the consensus for each recommendation of this guideline. Results: the level of evidence and the degree of recommendation for each item is presented in text form, followed by a summary of the evidence found. Conclusion: this guideline reflects the recommendations of the group of specialists of the Brazilian College of Surgeons, the Brazilian Society of Parenteral and Enteral Nutrition and the ACERTO Project for nutritional interventions in the perioperative period of Elective General Surgery. The prescription of these recommendations can accelerate the postoperative recovery of patients submitted to elective general surgery, with decrease in morbidity, length of stay and rehospitalization, and consequently, of costs. Keywords: Perioperative Care. Nutritional Therapy. Protocols. Practice Guideline.

INTRODUCTION

I

n recent years there has been important technological developments in the fields of surgery and anesthesia. Many perioperative conducts, usually employed and empirically passed over decades, are now obsolete in the light of evidence and should therefore be abandoned. New equipment and new access techniques to body cavities have been developed thanks to laparoscopic and robotic operations. Laparoscopy alone showed that traditional care, such as early postoperative feeding and discharge are safe and feasible. In parallel, several guidelines of multimodal protocols3,4 based on randomized studies and meta-analyzes have

also shown in recent years that even in large open operations it is possible to abbreviate preoperative fasting with liquids containing carbohydrates for two hours before anesthesia, to feed early in the postoperative period and to reduce the length of hospital stay safely. In 2005, the ACERTO Project (Acceleration of Total Postoperative Recovery), based on a large bibliographical review on perioperative care, initiated a pioneering multimodal program in the Brazilian territory, which, from its conception, highlighted the importance of nutritional issues in the recovery of the surgical patient5. Evidence-based Medicine has widely shown that postoperative recovery-acceleration programs, similar to ACERTO, are safe, reduce postoperative com-

1 - Federal University of Mato Grosso, Post-Graduate Course in Health Sciences, Cuiabá, MT, Brazil. 2 - Várzea Grande University Center (UNIVAG), Várzea Grande, MT, Brazil. 3 - University of São Paulo, Faculty of Medicine, Department of Gastrenterology, São Paulo, SP, Brazil. 4 - Federal University of Minas Gerais, Alfa Institute of Gastrenterology, Clinics Hospital, Belo Horizonte, MG, Brazil. 5 - Federal University of Paraná, Post-Graduation Program in Clinical Surgery, Curitiba, PR, Brazil. 6 - Faculty of Medical Sciences of the Santa Casa de São Paulo, Department of Surgery, São Paulo, SP, Brazil. 7 - Federal University of the State of Rio de Janeiro (UNIRIO), Department of General and Specialized Surgery, Rio de Janeiro, RJ, Brazil. Rev Col Bras Cir 2017; 44(6): 633-648


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plications and hospitalization time, without increasing readmission rates6-8. Although the association between malnutrition and adverse postoperative outcomes is well known, the prescribing of perioperative nutritional therapy as recommended by these modern guidelines, supported by important medical societies, is still forgotten among surgeons9. With more than ten years of existence, the ACERTO Project has been increasingly widespread and used throughout the country, as well as in Latin American countries that have epidemiological realities and similar conducts to those we have in Brazil. Being a model for dynamic decision-making, throughout this period the program has been constantly updated, including new scientific information from the publication of methodologically well-designed studies. The purpose of this Guideline is to present recommendations from specialists of the Brazilian College of Surgeons and the Brazilian Society of Parenteral and Enteral Nutrition on various nutritional prescriptions applied to the perioperative period of elective procedures in general surgery based on the latest evidence proposed by the ACERTO Multimodal Project.

METHODS The authors searched the main databases (Medline, Scopus, SciELO and Cochrane) between 2006 and 2016 on clinical studies involving perioperative nutritional care for elective operations in general surgery following the precepts of McKeever et al.10. The Medical Subjects Headings used as keywords were “fasting”, “preoperative care”, “surgery”, “nutritional therapy”, “perioperative care” and “immune nutrition”. The keywords were combined individually or together with other specific areas of general surgery such as “colon”, “stomach”, “esophagus”, “pancreas”, “gallbladder”, “liver”, “Biliary tract”, etc. In addition, we also searched for terms not present in Medical Subjects Headings such as “fast track”, “enhanced recovery after surgery”, “ERAS”, “ACERTO”. Some routines and guidelines were cited in some contexts, but did not interfere in the evaluation of the recommendations. We excluded review articles (non-systematic)

and consensuses. We selected randomized controlled trials, systematic reviews and meta-analyzes. In the absence of these studies, we also selected and analyzed cohort studies with appropriate methods. We defined “General surgery” in the context of this Guideline as those procedures performed on the digestive tract, abdominal wall and head and neck surgery. Excluded from this definition were surgery for abdominal organ transplantation, those performed on an emergency basis or in critical care, pregnant and pediatric patients. The authors first elaborated recommendations on several topics, previously selected and grouped as answers to guiding questions, formulated in order to address the main issues inherent to the decision-making process of the surgical patient, in the context of the objectives proposed for this Guideline. Each recommendation was then put to the vote and suggestions, by means of an anonymous questionnaire for collecting information, specially constructed for the elaboration of this Guideline, using the online SurveyMonkey® tool (http://www.surveymonkey.com, SurveyMonkey Inc., Palo Alto, Calif., USA), and based on the adapted Delphi method11. A consensus was reached when at least 60% of the panel authors agreed with each recommendation. The quality of the evidence and the strength of the recommendations were graded by the GRADE System (Grading of Recommendations, Assessment, Development and Evaluation)12. By this method, each information is assigned a degree of evidence and a strength of recommendation. The degree of evidence represents confidence in the information used and was classified into four levels: High, Moderate, Low or Very Low. In turn, the strength of recommendation expresses the emphasis on whether a particular conduct is adopted or rejected, considering potential advantages and disadvantages, such as effect size, quality of evidence and intervention costs, and was classified as Strong or Weak. To exemplify, a recommendation classified as Strong would be one in which the authors are confident that the desired effects on adherence to this recommendation outweigh possible undesirable effects. On the other hand, a Weak recommendation would be one in which the desired effects on adhe-

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rence to a particular conduct also outweighs undesirable effects, but the authors are not so confident for a Strong recommendation. It is necessary to clarify that the recommendation (Strong or Weak) is not only based on the quality of the studies that support it, but also on the balance between desirable and undesirable effects of the conduct applied In this way, a Strong recommendation, for example, may have a low quality of evidence. 1. Should the patient receive preoperative information? “The patient should receive, preferably in writing (booklet, pamphlet) guidelines and advice that help him/her have a fast recovery in the perioperative period.” Degree of recommendation: STRONG Evidence Strength: LOW Transmitting some information about the operation to the patient may decrease anxiety, as well as “help one help oneself” postoperatively13. For example, knowing that one can shorten preoperative fasting time for certain types of liquids, that one can feed and ambulate early postoperatively, etc., may increase the patient’s adherence to these behaviors, especially at times when the surgeon or other members of the multiprofessional team are not present. Likewise, preoperative information enables preconceived or ingrained ideas about the perioperative period, such as the prohibition of walking or the need for an excessively long period of fasting, to be clarified and no longer affect or interfere with the conduct of accelerated recovery through the multimodal program. This information should be preferably available in the form of a pamphlet or small booklet that should be given to the patient. Aguilar-Nascimento et al.15 observed a lower risk of nausea and postoperative pain in the group that received preoperative information in a systematized manner. The information should include, in addition to estimated discharge time, nutritional guidelines of abbreviated preoperative fasting (six hours for solids and two hours for carbohydrate containing liquids), early feedback and ambulation, among others.

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2. Should a pre-habilitation program be recommended prior to surgery? “A pre-habilitation program should be performed before surgery in patients at higher risk (less functional reserve) by combining physical exercises with other measures, such as adequate nutritional care. Most studies show improvement in postoperative functional capacity, but without reducing the rate of complications and without reducing length of hospital stay.” Degree of Recommendation: WEAK Evidence Strength: LOW Malnutrition is an important cause for decreased muscle mass. However, currently other situations in which loss of muscle mass may have occurred have been well studied, among them sarcopenia. Primary sarcopenia is related to the aging process, but other causes have also been associated 16. Because sarcopenia is amenable to reversal through nutritional interventions and progressive resistance training, it becomes a potentially modifiable risk factor in elective surgical patients. In the postoperative period, several factors can alter body composition, especially at the expense of muscle mass consumption. The operation must be analyzed from the metabolic point of view as a planned trauma. The purpose of the surgical pre-habilitation is to prepare the patient to support the surgical stress with the least possible physical and functional repercussion, with the improvement of the parameters of physical conditioning before the operation, in order to optimize postoperative recovery and to maintain the muscular physical function. The ideal pre-habilitation program should be done for a period of four weeks, intercalating aerobic and resistance exercises 17. In addition to nutritional care and physical conditioning, other care should be part of the preoperative optimization, such as cessation or reduction of smoking and alcohol use, optimization of doses of medications used, and compensating diabetes mellitus, hypertension and cardiopulmonary function whenever indicated. Li et al.18 carried out a study in patients submitted to resection of colorectal cancer in two periods,

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before and after the intervention with pre-habilitation. The results showed benefits in functional capacity only in patients in the intervention group. There was no difference in morbimortality or hospitalization time. However, Valkenet et al.19, in a systematic review, showed that preoperative physical exercises are effective in decreasing the time of postoperative hospitalization and reducing complications in patients undergoing cardiac and abdominal surgery. In another study, 77 patients who were candidates for colorectal cancer surgery were randomized to receive preoperative exercises for four weeks at home (n=38) or not (n=39). Again, there was improvement in physical capacity tests, but there was no difference in terms of postoperative complication rates and hospitalization time20. Bruns et al.21 recently published a systematic review involving five studies in the elderly undergoing colorectal surgery. None of the studies showed improvement in complication rates and length of hospital stay. Four studies showed improvement in functional capacity with pre-habilitation. 3. Is there a benefit in prescribing preoperative nutritional therapy? “Oral, enteral or parenteral preoperative nutritional therapy should be instituted for patients who are candidates to moderate to major operations and have moderate to high nutritional risk, accessed by any of the available methods.” Degree of recommendation: STRONG Evidence Strength: HIGH The nutritional status interferes with the postoperative results. The more compromised the nutritional status, the higher the risks of morbidity and mortality, and therefore the higher hospital costs22,23. This is much more evident among the elderly24. The preoperative evaluation of nutritional status and, even better, nutritional risk for postoperative morbidity and mortality should be established preferentially by the use of the NRS-200225 tool. In this context, the prescription of 5-10 days of preoperative nutritional therapy, preferably by the oral use of protein supplements or, if not possible, enterally or parenterally, improves the aforementioned outcomes26-30. The positive results of

this nutritional intervention were demonstrated mainly in studies involving patients operated on for cancer of the digestive tract or of the head and neck region31,32 4. Are immunonutrient-containing formulations indicated in the perioperative period? “The nutritional formula used in the perioperative period may contain immunonutrients or not. However, in patients at greater risk and undergoing major surgery, nutritional therapy should include immunonutrients, both by the oral and enteral routes.” Degree of recommendation: STRONG Evidence Strength: HIGH In recent years, much emphasis has been placed on the use of immunonutrition as a complement to the protein formula of oral supplements or enteral nutrition. Most of the studies used nutritional formulas containing arginine, omega-3 fatty acids and nucleotides. This interaction of immunonutrients can favorably modulate the inflammatory response, improve the immune response and promote healing33. Although there are studies that have not shown differences in postoperative outcomes34, in the great majority of them the use of diet with immunonutrients was related to the reduction of complications, mainly infectious, and decreased hospitalization time35-37. The addition of arginine, omega-3 fatty acids and nucleotides to conventional nutritional supplements confer these additional perioperative nutritional advantages. There are more than 50 prospective, randomized studies on the subject in the literature today, which were the subject of five meta-analyzes. Braga et al.38 recently reviewed the five meta-analyzes and consistently confirmed that in severe or moderate malnutrition, pre-operative nutritional therapy for seven to 14 days with diets enriched with immunonutrients is associated with reduction of postoperative infections and length of hospital stay. In addition, these benefits may be associated with a reduction in hospital costs, considering the reduction of length of stay in the ICU, antibiotic use, length of mechanical ventilation time, risk of rehospitalization etc39. In head and neck surgery, a meta-analysis showed a decrease in length of hospital stay, though with no significant difference in

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the incidence of postoperative complications with the use of an immunomodulatory diet40. Regarding the most appropriate period of administration, a recent meta-analysis suggested that administering diets enriched with immunonutrients is more beneficial throughout the perioperative period (pre and postoperative) or only postoperatively than only preoperatively37. 5. How should preoperative fasting be prescribed to ensure patient safety and benefit? “Pre-operative fasting should not be prolonged. For most patients who are candidates for elective procedures, it is recommended they fast six to eight hours before anesthetic induction. Carbohydrate-containing liquids (maltodextrin) should be ingested up until two hours of anesthesia, except for cases of delayed esophageal or gastric emptying or emergency procedures.” Degree of recommendation: STRONG Evidence Strength: HIGH There is extensive documentation in the literature showing safety in the abbreviation of fasting for two hours prior to anesthetic induction41,42. The volume of gastric residue with 12, eight, or six hours of complete fasting is similar to that found in fasting of six hours for solids and two hours for clear liquids, with or without carbohydrates43,44. The meta-analysis results involving 27 studies and 1976 participants did not show any case of aspiration or pneumonia with the abbreviation of preoperative fasting for 2h to 3h45. For this reason, a recent systematic review of 19 different preoperative fasting guidelines showed that there is agreement in recommending avoiding prolonged fasting and safety in the prescription of clear liquids containing or not carbohydrates up to two hours prior to anesthetic induction46. Although fasting after midnight is a difficult dogma to be modified, some studies show an increasing adherence of surgeons and anesthetists in adopting these new recommendations47. Despite contradictory findings48, the benefits of the abbreviation of preoperative fasting, pointed out by several authors, are in the improvement of metabolic parameters, especially with the reduction of insulin resistance33,49-51, immunomodulation with less

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inflammatory reaction52-56 and increased postoperative functional capacity57. Studies also show a reduction in hospitalization time in larger operations58,59, reduction of anxiety, thirst and hunger32,33,60,61, and reduction of postoperative nausea and vomiting62,63. 6. Can carbohydrate and protein-containing beverages be used to shorten preoperative fasting? “Beverages containing carbohydrates associated with protein source (glutamine or whey protein) can safely be ingested up until three hours before the anesthetic procedure.” Degree of Recommendation: WEAK Strength of Evidence: MODERATE The addition of nitrogen source containing glutamine, protein hydrolyzate or whey protein to the carbohydrate-containing beverage, besides being safe64,65, seems to increase the benefits associated with improved insulin sensitivity, functional capacity, higher glutathione production and lower acute Inflammatory reaction42,43,66,67. Although all randomized studies to date indicate safety, they are still few in comparison to those who used only maltodextrin and, in addition, they included few patients42,43,66,67. Some old limitations of the abbreviation of preoperative fasting are being modified, such as for the diabetic patient or for the patient undergoing obesity surgery. There have been at least three randomized studies that have shown safety in abbreviating fasting in obese patients undergoing bariatric surgery68-70. Patients with controlled diabetes mellitus, not using without insulin and without gastroparesis can undergo abbreviated fasting71. However, due to the lack of studies in these groups of patients, it should be considered that more data are needed for a better understanding of the abbreviation of fasting in morbidly obese and diabetic patients. 7. When should feeding be restarted in the postoperative period? “Oral or enteral feeding should restart early after elective abdominal surgery (within 24 hours) as long as the patient is hemodynamically stable. This

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recommendation applies even in cases of digestive anastomoses. In operations such as laparoscopic colecystectomy, herniorrhaphy and anorectal surgery, immediate onset of diet and oral hydration is recommended, without the use of intravenous hydration.â&#x20AC;? Degree of recommendation: STRONG Evidence Strength: HIGH There is extensive documentation in the literature about the safety of early refeeding of patients submitted to elective abdominal, anorectal, or abdominal wall procedures. Meta-analyzes and randomized studies published over a decade ago report the safety of such conduct72-75. This includes upper digestive tract operations, such as esophagectomies76,77, gastrectomies78 and duodenopancreatectomies79. In addition to safety in relation to the occurrence of anastomotic dehiscence, several of these authors demonstrated a decrease in infectious complications and length of hospitalization80-82. The oral route should be the first option for early feedback, even after large procedures83. The current trend in the postoperative period is to avoid prolonged fasting and to abandon the classic oral diet from liquid to pasty and finally solid and to allow an oral precocious diet at will81,84. According to the reviewed studies, although the tolerance of the patient to the resumption of the diet is not universal, it is generally high85-87 (above 70%), and may be even greater with the association of the prescription of other perioperative routines present in multimodal acceleration protocols of postoperative recovery. These include preoperative information (as discussed above), use of chewing gum from the immediate postoperative period on88, early mobilization89, use of prokinetic drugs such as alvimopan90 (not yet marketed in Brazil), non-use of opioid medication91, and avoiding overload of perioperative intravenous fluids through the use of more rigorous therapy strategies (target-directed therapy)92,93 or even restrictive ones94, especially with regard to the use of crystalloid solutions and with high sodium content. Still in this respect, careful management of intravenous crystalloid liquids on the day of operation is warranted. The greater the volume infused, the longer the postoperative ileus period, the greater the

intolerance to the early diet and the longer the hospitalization90,95. Finally, the use of intravenous lidocaine for analgesia under continuous infusion has shown to accelerate recovery of postoperative ileus and increase tolerance to resumption of postoperative feeding96. 8. When should postoperative nutritional therapy be prescribed? I. â&#x20AC;&#x153;Postoperative nutritional therapy by catheter (naso-jejunal, naso-gastric, gastrostomy or jejunostomy), should be considered at an early stage (24 hours postoperatively): 1) for patients undergoing major operations of the head and neck (i.e, total laryngectomy) and upper gastrointestinal tract (esophageal resections, total gastrectomy, and pancreatic resections / shunts), when early oral nutrition is impossible or not recommended; or 2) in those patients who cannot reach 60% of the proposed nutritional goal after 5 to 7 days postoperatively with the oral route alone.â&#x20AC;? Degree of recommendation: STRONG Evidence Strength: HIGH In some situations, usually associated with major operations, the oral route cannot be used or is not recommended. Patients with biliary and pancreatic cancer are a good example. Intolerance to the oral route due to previous malnutrition, malabsorption, prolonged gastric stasis and, mainly, anorexia represent barriers to oral post-operative nutrition97. In these situations, postoperative nutrition should be precocious and prescribed enterally or parenterally98,99. In this perspective, studies conducted in the 1990s have shown that, when compared, enteral nutrition is associated with a lower risk of morbidity and length of hospital stay in the postoperative period than parenteral nutrition100,101. More recent studies continue to reaffirm the superiority of enteral nutrition in relation to parenteral nutrition72,102-104, although there are publications that have not shown differences in results between these routes when compared95,96. This is probably due to modifications in parenteral nutrition formulation. For enteral therapy, the use of nasoenteric catheters, percutaneous gastrostomy or jejunostomies are recommended95,105. According to a recent syste-

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matic review, there is no definition as to which route (including oral) is ideal following esophagectomy106. Severe complications involving the catheter are more common with jejunostomy107,108. However, a recent randomized study showed that nutrition by nasoenteric catheter or by jejunostomy is equivalent in terms of morbidity and length of stay, but jejunostomy allows the use of nutritional therapy for longer periods, especially in patients with complications, avoiding the use of parenteral nutrition109. II. “Prescription of enteral formulas containing intact protein and low percentage of lipids is recommended in the majority of patients undergoing large abdominal operations. For severe malnourishment, cancer of the digestive system or cancer of the head and neck, nutritional therapy with immunonutrients is recommended.” Degree of Recommendation: WEAK Strength of Evidence: MODERATE We identified no studies comparing formulas containing intact versus hydrolyzed protein in the postoperative period. Many studies, however, have been carried out with polymeric formulas. A recent randomized study compared the use of low-fat elemental formula with polymer formulation and with normal percentage of fat in patients submitted to esophagectomy and extended lymphadenectomy due to cancer. The elemental formula with low fat content was associated to a lower incidence of lymphatic fistula in the postoperative period110. Formulas containing immunonutrients are indicated in the early postoperative period of malnourished patients in need of enteral nutrition. This recommendation is based on many randomized studies111-113 and meta-analyzes102,104,114,115 that reported a lower rate of postoperative infection and length of hospital stay. However, there is no evidence of reduction in mortality. It is recommended no more than 25kcal/kg/ day for most patients on enteral nutritional therapy in the first postoperative days, with protein intake of approximately 1.5g/kg/day. III. “When it is impossible to use the digesti-

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ve tract or when the caloric supply fails to reach 60% of the planned caloric target after five postoperative days, parenteral nutritional therapy should be prescribed, either alone or in combination with enteral nutrition.” Degree of Recommendation: WEAK Evidence Strength: LOW No randomized trials were conducted in postoperative patients whose objective was to compare clinical results with parenteral nutrition alone or in combination with enteral nutrition. Likewise, we identified no randomized trials comparing the best period for initiation of parenteral nutrition in the postoperative period. There are studies that have evaluated the timing of initiating parenteral nutrition in critically ill intensive care patients, but are beyond the scope of this guideline. The early initiation of parenteral nutrition (up to the third postoperative day) has been recommended in societies guidelines when isolated enteral nutrition is not sufficient or contraindicated116, as opposed to prolonged ileus, for example. Some guidelines for intensive care patients (involving several types of patients, including those in the postoperative period) recommend the associated or isolated use of parenteral nutrition only after the first postoperative week117,118. Formulas containing omega-3 fatty acids determine a minor postoperative acute-phase inflammatory reaction119-121, although this has not been confirmed in some studies. The use of intravenous glutamine in the postoperative period of patients receiving parenteral nutrition was safe in a recent multicenter study122. However, it did not modify the postoperative clinical results123. 9. In what patients should specialized nutritional therapy be maintained after discharge? “Oral nutritional therapy (with oral supplements) or enteral nutrition should be maintained after discharge in patients who have used nutritional therapy in the perioperative period and still cannot maintain protein-calorie needs only by mouth.” Degree of recommendation: STRONG

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Evidence Strength: LOW

post-operative nutritional deterioration134,135.

The risk of postoperative infectious complications in malnourished patients, especially in large operations, is quite high. In recent years, special attention has been devoted to the risk of rehospitalization in surgical patients124. In addition to being an indicator of morbidity, readmissions are strongly correlated with increased hospital costs125. The main risk factors associated with rehospitalization in this group are malnutrition and inadequate functional status (high ASA score, for example)126-128. As previously discussed, perioperative nutritional therapy is recommended in these cases, as there is sufficient evidence that this can positively influence this outcome and reduce the need for rehospitalization. However, many patients on perioperative nutritional therapy are discharged after a few days without guidance to maintain adequate nutrient supply. This leads to a greater risk of rehospitalization and of high late morbidity and mortality129. The use of nutritional strategies, including the prescription of oral supplements in the postoperative period and after discharge from patients undergoing major operations, can prevent complications and reduce the chances of readmission130,131. This is especially important in elderly patients132. Maintenance of enteral nutrition in home care (with home-based nutritional therapy) may contribute to increase nutritional intake after major operations133 and prevent

Areas for future research Few studies have investigated the effects of preoperative education on elective general elective surgery patients, although there is a strong recommendation for this practice. There is also a lack of studies on the effects of pre-habilitation on postoperative results. Further knowledge of the deleterious effects of preoperative sarcopenia and ways to reverse it before surgery can bring valuable information to improve recommendations in the future. Further studies on the use of nitrogen sources in preoperative oral supplements are also awaited, although there is enough literature to recommend them. Likewise, more studies on early feeding after esophagectomies and total gastrectomy are expected so as to enable the elaboration of specific recommendations on early oral route feeding for these operations. There is also a lack of studies on formulas with intact or hydrolyzed nutrients in the postoperative period. In the same way, there is a lack of studies to clarify the best time to initiate parenteral nutrition therapy in non-critical patients postoperatively. In this article, we synthesized the possible recommendations in light of the evidence. The prescription of these recommendations can accelerate the postoperative recovery of patients submitted to elective general surgery, with decrease in morbidity, length of stay and rehospitalization, and consequently, of costs.

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resection of an upper gastrointestinal malignancy. Clin Nutr. 2016 Nov 5. pii: S0261-5614(16)31314-0. [Epub ahead of print]. 134. Bowrey DJ, Baker M, Halliday V, Thomas AL, Pulikottil-Jacob R, Smith K, et al. A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study. Trials. 2015;16:531. 135. Gavazzi C, Colatruglio S, Valoriani F, Mazzaferro V, Sabbatini A, Biffi R, et al. Impact of home enteral nutrition in malnourished patients with upper gastrointestinal cancer: a multicentre randomised clinical trial. Eur J Cancer. 2016;64:107-12. Received in: 22/06/2017 Accepted for publication: 20/07/2017 Conflict of interest: none. Source of funding: none. Mailing address: JosĂŠ Eduardo de Aguilar Nascimento E-mail: je.nascimentocba@gmail.com / aguilar@terra.com.br

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Review Article

DOI: 10.1590/0100-69912017006011

Can reducing the number of stitches compromise the outcome of laparoscopic Burch surgery in the treatment of stress urinary incontinence? Systematic review and meta-analysis A redução do número de pontos pode comprometer o resultado da cirurgia de Burch por via laparoscópica no tratamento da incontinência urinária de esforço? Revisão sistematizada e metanálise RICARDO JOSÉ SOUZA1,2; JOSÉ ANACLETO DUTRA RESENDE JÚNIOR1-4; CLARICE GUIMARÃES MIGLIO1; LEILA CRISTINA SOARES BROLLO2; MARCO AURÉLIO PINHO OLIVEIRA1,2; CLAUDIO PEIXOTO CRISPI, TCBC-RJ1,4. A B S T R A C T The retropubic colposuspension in the treatment of stress urinary incontinence has been rescued with the laparoscopic route. Some authors have reduced the number of stitches, from two to one, due to the difficulty of suturing by this route. To what extent can this modification compromise outcome? To answer this question, we performed a systematic review and meta-analysis on the MEDLINE/PubMed and LILACS/SciELO databases between 1990 and 2015. We included randomized clinical trials, cohort studies and case-control series comparing laparoscopic versus open Burch, and two versus one stitch in laparoscopic Burch, with a minimum follow-up of one year. Fourteen studies compared laparoscopic versus open Burch, in which we found no differences between the two techniques using one stitch (Relative Risk – RR – of 0.94, 95% CI 0.79-1.11) and two stitches (RR of 1.03, 95% CI 0.97-1.10). Only one study compared one stitch versus two stitches in laparoscopic Burch, with cure rates of 68% versus 87%, respectively (p-value= 0.02). We did not identify differences when compared open technique with two stitches versus laparoscopic with one stitch and open technique with two stitches versus laparoscopic with two. The study comparing one versus two laparoscopic stitches demonstrated superior results with the latter. Although there is no robust evidence, when Burch surgery is performed laparoscopically, the use of two stitches seems to be the best option. Keywords: Urinary Incontinence, Stress. Laparoscopy. Treatment Outcome. Review. Meta-Analysis.

INTRODUCTION

I

n 1961, Burch described the surgical technique of suspending the urethra and abdominal vagina using the Cooper’s ligament as a point of support in the treatment of stress urinary incontinence (SUI)1. Tanagho2 subsequently described the technique modification, not completely approaching the endopelvic fascia to the Cooper ligaments, which is described in most articles. The long-term success of Burch’s open (OB) operation was demonstrated by Sivaslioglu et al.3 in 262 patients with 84% cure rate at seven years. In 1991, the technique was first described laparoscopically (LB)4. Prezioso et al.5 carried out a randomized study using the laparoscopic technique in 96 women, with similar re-

sults to OB, but with significant advantages such as less bleeding and less time to return to work. One of the difficulties in comparing the results of the open technique with the laparoscopic one is caused by the various modifications made in the laparoscopic route, more frequently in the number of stitches, which require more time and training when performed by that pathway. Some authors performed surgeries using one or two stitches on either side of the urethra, perhaps in order to reduce surgical time. The objective of this study was to evaluate, through a systematic review of the literature, whether the laparoscopic Burch technique with two stitches on each side of the urethra is superior to that performed with a single stitch and, secondarily, to verify if the lapa-

1 - Faculty of Medical Sciences and Health of Juiz de Fora (FCMS/JF), Juiz de Fora, MG, Brazil. 2 - University of the State of Rio de Janeiro, Rio de Janeiro, RJ, Brazil. 3 - Federal Hospital of Lagoa, Rio de Janeiro, RJ, Brazil. 4 - Crispi Institute of Minimally Invasive Surgery, Rio de Janeiro, RJ, Brazil. Rev Col Bras Cir 2017; 44(6): 649-654


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roscopic technique with one and two stitches is better than the open, classic Burch with two stitches.

METHODS We performed a systematic search in the MEDLINE/ PubMed and LILACS/SciELO databases for articles published from 1990 to 2015 in the English, Portuguese or Spanish languages. Using the keywords “laparoscopy”, “laparoscopic”, “burch”, “colposuspension”, “urethropexy” and “urinary incontinence”, we developed the following search strategy: AND (burch OR urethropexy OR colposuspension) AND (laparoscopy OR laparoscopic). The inclusion criteria of the articles were randomized clinical trials, cohort and case-control studies comparing laparoscopic Burch with two stitches with those who performed one stitch on each side of the urethra, as well as randomized clinical trials, cohort and case-control studies comparing laparoscopic Burch with classic open Burch with two stitches. The studies had to inform the follow-up time, of at least one year, to clearly describe the technique used in each group, separating them (one or two stitches on each side of the urethra) and to describe the criteria used to evaluate treatment results. We excluded studies that did not report whether patients had undergone previous surgeries for urinary incontinence or in which there was no uniform distribution between groups with previous treatment for incontinence.

Based on these criteria, two independent examiners (RJS and JADRJr) evaluated all selected articles, in three stages: evaluation by the titles (first stage), then evaluation by the abstracts (second stage) and finally evaluation of the articles in full (third stage). For the articles that generated conflicts between the examiners, we held consensus meetings, involving a mediator for final decision (LCSB) We used the Oxford criteria6 to define the levels of scientific evidence.

RESULTS We found 273 studies in MEDLINE/PubMed and none in LILACS/SciELO. Of those, we selected fifteen studies, 14 of which compared laparoscopic and open techniques and one compared one with stitches on each side of the urethra through the laparoscopic route. Of the 14 studies comparing open laparoscopic techniques, we excluded two, one for reporting results with less than one year of follow-up7 and another for having included in the laparoscopic group women treated with one and two stitches, not being possible to analyze the data separately8. The 12 studies included in this review compared the results of OB with LB, two of which were randomized and controlled, one retrospective cohort study and one retrospective using only one stitch on each side of the urethra. The others used two stitches on each side of the urethra, one being a case-control, three retrospective cohorts and four randomized and controlled studies (Table 1).

Table 1. Comparative studies: laparoscopy versus open - 1 and 2 stitches.

Previous Surgical Follow-up time Treatment (months)

1 or 2 stitches LB

Author

Year

Study type

Barr

2009

Retrospective cohort

Yes

120

2

Kitchener Ankardal Carey Dietz Hunag Cheon Lavin Fatthy Su Miannay Polascik

2006 2005 2006 2004 2004 2003 1998 2001 1996 1998 1994

Randomized, controlled Randomized, controlled Randomized, controlled Case-control Retrospective cohort Randomized, controlled Retrospective cohort Randomized, controlled Randomized, controlled Retrospective Retrospective cohort

Yes No Yes Yes No No Yes Yes No No Yes

24 12 24 12 >12 12 24 18 12 24 20.8

2 2 2 2 2 2 2 1 1 1 1

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Meta-Analyzes Two-stitch OB versus one-stitch LB Of the four articles that compared the two-stitch OB versus LB techniques using only one stitch, it was possible to perform a meta-analysis with only three of the studies due to the divergence of the techniques used (Figures 1 and 2).

Figure 3. Funnel plot – analysis considering the eight selected publications12-18; total heterogeneity/variability (I2) = 11.89% (p=0.007).

Figure 1. Funnel plot – analysis considering the three selected publications9,11,12; total heterogeneity/variability (I2) = 40.11% (p =0.038).

Figure 4. Forest Plot – relative risk assessing cure between studies involving the LB versus OB techniques.

DISCUSSION

Figure 2. Forest Plot – relative risk assessing cure between studies involving LB versus OB techniques.

Two-stitch OB versus two-stitch LB By extracting the information from the eight articles that compared the two-stitch OB versus the two-stitch LB, we did not observe statistical difference between the two groups (Figures 3 and 4).

Regarding published studies comparing OB versus LB, some authors used different techniques, especially when it comes to the number of stitches used in the laparoscopic route. Polascik et al.9, in 1994, performed a retrospective cohort study (Level of Evidence 4). They analyzed data from 22 patients, 12 of whom were submitted to LB and ten to OB. With an average follow-up period of 20.8 months, they found similar cure rates (LB=83% vs OB=70%, p-value non-significant). In that study, the authors described performing the laparoscopic technique with one stitch on each side of the urethra. Subsequently, in 1998, Miannay et al.10, also using one stitch on each

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Souza Can reducing the number of stitches compromise the outcome of laparoscopic Burch surgery in the treatment of stress urinary incontinence?

side in the laparoscopic technique, performed a retrospective study (Level of Evidence 4) comparing the data of 144 patients submitted to LB and OB, finding no statistical difference between the cure rate of the two procedures (LB=68% vs OB=64%, p-value non-significant) after a 24-month follow-up. These authors performed laparoscopic surgeries with only one stitch on each side of the urethra comparing with the two classic stitches by the open technique. In the same line of previous studies, we found two prospective studies that were published using one stitch on each side of the urethra in the laparoscopic technique. Su et al.11, in a controlled, randomized, prospective study (Level of Evidence 1B) conducted in 1996, studied 72 patients with a minimum follow-up period of 12 months, dividing into two groups. The cure rate for patients submitted to LB was 80.4% and 95.6% for OB (p-value non-significant). This was the only study that found a laparoscopic surgical time shorter than the open technique. The second controlled, randomized, prospective study (Level of Evidence 1B) conducted by Fatthy et al.12 compared 40 women in the LB group and 34 in the OB group. The authors performed only one stitch on each side of the urethra, both in the laparoscopic surgery and in the open procedure, and also found no difference in cure rates (OB=85% vs LB=87.9%, p-value non-significant). When we analyzed the studies with two stitches on each side of the urethra, we found a retrospective cohort study (Level of Evidence 4) conducted in 1998 by Lavin et al.13, who reviewed the data of two years and the complaints, by telephone contact, of 70 women submitted to LB and 46 submitted to OB. They found subjective cure in 57.8% and 50% patients, respectively (p-value non-significant). Two aspects are important in the analysis of this study: the suture used in the laparoscopic Burch was absorbable (polydioxanone-PDS), different from the open technique and from other studies, which used nonabsorbable sutures, and OB follow-up time was two years longer than LB. Huang et al.14 conducted a retrospective cohort study (Level of Evidence 4) with the use of two stitches and non-absorbable suture. They compared 75 patients in the open procedure with 82 in the laparosco-

pic one and found a subjective success rate of 84% for OB and 89% for LB, with follow-up of at least one year. In a third study in the same vein, Barr et al.15 reviewed a series (Level of Evidence 4) of 139 women submitted to LB between 1993 and 1995 and compared with 52 patients submitted to OB in the same period. In a long-term evaluation (10 years), there was no difference between cure rates in the two techniques. However, there was a significant drop in cure rates over time in both groups. The results were 58% and 50% in two years (p=0.364) and 48% and 32% (p=0.307) in ten years (LB versus OB, respectively). In a case control study (Level of Evidence 3B) of 50 patients in each group, Dietz et al.16, in 2004, did not find statistical differences between the two procedures by using subjective cure criteria. During the effort, 37 women from the LB group and 40 from the OB one remained dry (p-value non-significant). We found four prospective, randomized studies in the review comparing the two techniques. Cheon et al.17, in 2003, in a clinical trial (Level of Evidence 1B) with 90 women presenting SUI, found no statistical difference between the two techniques. Considering cure and improvement of SUI, they found 80.9% and 86% success in one year of follow-up, in the laparoscopic and open path, respectively (p-value non-significant). In 2006, Carey et al.18 conducted a study with 200 incontinent women (Level of Evidence 1B). After 24 months of follow-up, there was no difference between groups regarding urinary incontinence, with 66% of the women remaining continent. The authors observed a twice-longer surgical time in the laparoscopic approach, but with less blood loss and postoperative pain. Ankardal et al.19, in a study (Level of Evidence 1B) including 211 patients (OB=79, LB=53 and laparoscopic mesh colposuspension =79) found no difference between techniques that used stitches at one year of follow-up, with 56% of women with OB and 55% with LB without complaints or urinary losses (p-value non-significant. Kitchener et al.20 found an objective cure rate (negative pad test) of 80% for laparoscopy and 70% with the open technique in a two-year follow-up. We found a single published article comparing the technique of two stitches with the one of one stitch on each side of the urethra using the laparosco-

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pic approach. Persson et al.21 conducted a randomized study (Level of Evidence 1B) using the colposuspension technique with fixation in the Cooper ligaments, laparoscopically, comparing one or two stitches on each side of the urethra. They excluded patients with previous surgical treatment for urinary incontinence. In patients with one stitch on each side, they performed two passes of the needle by the vaginal fascia (dubbed-bite), while in those with two stitches, they passed the thread only once in the fascia. They analyzed data from 83 women submitted to the one stitch technique and from 78 treated with two stitches. In that series, after one year of follow-up, in the group with two stitches 62 patients (83%) achieved an objective cure and 9 (12%) improved symptoms, compared with 43 (58%) cures and 20 (27%) improvements in those submitted to one stitch (p=0.001). They considered objective cure the absence of urinary loss in the pad test. There was no difference in the incidence of intra and postoperative complications between groups. The group in which two stitches were performed had a longer operative time (median

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of 17 minutes). The authors interrupted the study on ethical grounds after assessing the results of the first 108 women in the one-year follow-up. At this time, the group with one stitch had a healing result lower than the group of two stitches (68% versus 87%, p=0.02), but the data of 60 women had not yet been evaluated and were subsequently added.

CONCLUSIONS When comparing open and laparoscopic techniques, even the best level of evidence studies could not identify differences between procedures with one or two stitches. The only study found comparing one versus two stitches performed laparoscopically demonstrated that the result was superior with the technique using two stitches on each side of the urethra. Despite the lack of robust evidence, when Burch is performed by laparoscopy, the best option seems to be the use of two stitches, especially nowadays, when there is a trend in the advancement of laparoscopic suture techniques.

R E S U M O A colpossuspensão retropúbica no tratamento da incontinência urinária de esforço vem sendo resgatada com a via laparoscópica. Alguns autores reduziram o número de suturas, de duas para uma, devido à dificuldade de sutura por esta via. Até que ponto essa modificação pode comprometer o resultado? Para responder a esta pergunta, foi realizada uma revisão sistemática e metanálise nas bases de dados MEDLINE/PubMed e LILACS/SciELO entre 1990 e 2015. Incluímos ensaios clínicos randomizados, estudos de coorte, caso controle, comparando Burch laparoscópico versus Burch aberto e duas versus uma sutura no Burch laparoscópico, com follow-up mínimo de um ano. Quatorze estudos compararam Burch laparoscópico versus aberto, nos quais não encontramos diferenças entre as duas técnicas, utilizando uma sutura (Risco Relativo (RR) de 0,94 [IC 95% - 0,79-1,11]) e duas suturas (RR de 1,03 [IC 95% - 0,97-1,10]). Apenas um estudo comparou uma sutura versus duas suturas no Burch laparoscópico, com taxas de cura de 68% versus 87%, respectivamente (p-valor=0,02). Quando comparadas técnica aberta com duas suturas versus laparoscópica com uma sutura e técnica aberta com duas suturas versus laparoscópica com duas suturas, não identificamos diferenças. O estudo que comparou uma versus duas suturas laparoscópicas demonstrou resultado superior com a técnica de duas suturas. Apesar de não haver evidências robustas, quando a cirurgia de Burch for realizada por via laparoscópica, o uso de duas suturas parece ser a melhor opção. Descritores: Incontinência Urinária por Estresse. Laparoscopia. Resultado do Tratamento. Revisão. Metanálise.

REFERENCES 4. 1.

2. 3.

Burch JC. Urethrovaginal fixation to Cooper’s ligament for correction of stress incontinence, cystocele, and prolapse. Am J Obstet Gynecol. 1961;81:281-90. Tanagho EA. Colpocystourethropexy: the way we do it. J Urol. 1976;116(6):751-3. Sivaslioglu AA, Unlubilgin E, Keskin HL, Gelisen O, Dolen I. The management of recurrent cases after the Burch colposuspension: 7 years experience. Arch

5.

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Gynecol Obstet. 2011;283(4):787-90. Vancaillie TG, Schuessler W. Laparoscopic bladderneck suspension. J Laparoendosc Surg. 1991;1(3):169-73. Prezioso D, Iacono F, Di Lauro G, Illiano E, Romeo G, Ruffo A, et al. Stress urinary incontinence: long-term results of laparoscopic Burch colposuspension. BMC Surg. 2013;13 Suppl 2:S38. Retraction in: Prezioso D, Iacono F, Di Lauro G, Illiano E, Romeo G, Ruffo A, et al. BMC Surg. 2016;16(1):26. Centre for Evidence-based Medicine. Oxford Centre

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7.

8.

9.

10.

11.

12.

13.

14.

15.

Souza Can reducing the number of stitches compromise the outcome of laparoscopic Burch surgery in the treatment of stress urinary incontinence?

for Evidence-based Medicine - Levels of Evidence (March 2009) [Internet]. CEBM. 2009 [cited 2016 May 5]. Available from: http://www.cebm.net/ oxford-centre-evidence-based-medicine-levelsevidence-march-2009/ Bezerra CA, Rodrigues AO, Seo AL, Ruano JMC, Borrelli M, Wroclawski ER. Laparoscopic Burch surgery: is there any advantage in relation to open approach? Int Braz J Urol. 2004;30(3):230-6. Lyons TL, Winer WK. Clinical outcomes with laparoscopic approaches and open Burch procedures for urinary stress incontinence. J Am Assoc Gynecol Laparosc. 1995;2(2):193-8. Polascik TJ, Moore RG, Rosenberg MT, Kavoussi LR. Comparison of laparoscopic and open retropubic urethropexy for treatment of stress urinary incontinence. Urology. 1995;45(4):647-52. Miannay E, Cosson M, Lanvin D, Querleu D, Crepin G. Comparison of open retropubic and laparoscopic colposuspension for treatment of stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol. 1998;79(2):159-66. Su TH, Wang KG, Hsu CY, Wei HJ, Hong BK. Prospective comparison of laparoscopic and traditional colposuspensions in the treatment of genuine stress incontinence. Acta Obstet Gynecol Scand. 1997;76(6):576-82. Fatthy H, El Hao M, Samaha I, Abdallah K. Modified Burch colposuspension: laparoscopy versus laparotomy. J Am Assoc Gynecol Laparosc. 2001;8(1):99-106. Lavin JM, Lewis CJ, Foote AJ, Hosker GL, Smith AR. Laparoscopic Burch colposuspension: a minimum of 2 years’ follow up and comparison with open colposuspension. Gynaecol Endosc. 1998;7(5):2518. Huang WC, Yang JM. Anatomic comparison between laparoscopic and open Burch colposuspension for primary stress urinary incontinence. Urology. 2004;63(4):676-81; discussion 681. Barr S, Reid FM, North CE, Hosker G, Smith AR. The long-term outcome of laparoscopic colposuspension:

16.

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a 10-year cohort study. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20(4):443-5. Dietz HP, Wilson PD. Laparoscopic colposuspension versus urethropexy: a case-control series. Int Urogynecol J Pelvic Floor Dysfunct. 2005;16(1):15-8; discussion 18. Cheon WC, Mak JHL, Liu JYS. Prospective randomised controlled trial comparing laparoscopic and open colposuspension. Hong Kong Med J Xianggang Yi Xue Za Zhi Hong Kong Acad Med. 2003;9(1):10-4. Carey MP, Goh JT, Rosamilia A, Cornish A, Gordon I, Hawthorne G, et al. Laparoscopic versus open Burch colposuspension: a randomised controlled trial. BJOG. 2006;113(9):999-1006. Ankardal M, Milsom I, Stjerndahl JH, Engh ME. A three-armed randomized trial comparing open Burch colposuspension using sutures with laparoscopic colposuspension using sutures and laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence. Acta Obstet Gynecol Scand. 2005;84(8):773-9. Kitchener HC, Dunn G, Lawton V, Reid F, Nelson L, Smith ARB; COLPO Study Group. Laparoscopic versus open colposuspension--results of a prospective randomised controlled trial. BJOG. 2006;113(9):1007-13. Persson J, Wølner-Hanssen P. Laparoscopic Burch colposuspension for stress urinary incontinence: a randomized comparison of one or two sutures on each side of the urethra. Obstet Gynecol. 2000;95(1):151-5.

Received in: 01/06/2017 Accepted for publication: 21/07/2017 Conflict of interest: none. Source of funding: none. Mailing address: José Anacleto Dutra Resende Júnior E-mail: joseanacletojunior@gmail.com

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Technical Note

DOI: 10.1590/0100-69912017006007

Tumor lamination in mediastinal giant tumors Laminação tumoral nos tumores gigantes do mediastino

ELIAS KALLAS, TCBC-MG1; RAFAEL DINIZ ABRANTES1; ALEXANDRE CIAPPINA HUEB1.

A B S T R A C T Mediastinum tumors may grow slowly and reach giant proportions without symptoms, hindering surgical removal. Tumor big dimensions difficult surgical maneuvers, with risk of uncontrollable bleeding and prejudice to surrounding structures. It may be necessary the use of exceptional measures such as venous-venous circulatory deviation, pre-operatory embolization and total extracorporeal circulation. We describe the technique of tumor lamination that allows for complete or almost complete resection of such tumors that in many occasions are not resectable. The description is based on the results of four patients treated with mediastinum giant tumors. Keywords: Thoracic Surgery. Mediastinal Neoplasms. Surgical Procedures, Operative.

INTRODUCTION

TECHNIQUE

M

ediastinal tumors may grow slowly and reach giant proportions without symptoms1. After that, they may cause compressive phenomena of major structures, with the appearance of symptoms, leading the patient to seek medical help. At this moment, surgical removal is difficult, due to the giant dimensions of tumor, that difficult surgical maneuvers due to the smallness of space and/or invasion of major neighbor structures. The main threat is uncontrollable bleeding and the involvement of major surrounding organs. In view of these difficulties, the surgeon uses exceptional maneuvers such as venous-venous circulatory deviation2. Video-assisted resection is indicated for smaller tumors and is unappropriated for big volume tumors3. Also, it was proposed the use of pre-operatory

embolization and total extracorporeal circulation4. In view of such aspects, we decided to present the tumor lamination technique, based on the results presented by four patients with giant mediastinal tumors submitted to this technique. This work was initially submitted and approved by the Ethical Research committee of Fundação de Ensino Superior do Vale do Sapucaí by the number 1.873.568.

Access route varied according to localization of tumor: for those located at the posterior mediastinum, it was used thoracotomy at the 6th intercostal space, right or left (Figure 1); for those located at the antero-superior mediastinum it was accessed by median sternotomy (Figure 2). Once reached, the tumor is incised with thermal-cautery, and tumor tissue slices are removed, maintaining its capsule, avoiding lesion of adjacent structures (Figure 3). These maneuvers are repeated until the tumor is internally removed, maintaining a thin external lamina or capsule, when that is well defined (Figure 4). Then, the capsule is mobilized (after tumor internal removal) and the vascular pedicle is exposed and treated. Tumor capsule preservation or its external layers ease surgical maneuvers to reach surrounding structures and vascular pedicle. When it is not possible to identify the capsule, tumor lamination remove laminar fragments and therefore tumor volume, reducing its size, easing mobilization and pedicle approach (Figure 5). When major structures are involved, lamination must be interrupted in the vicinities as occurred in one of our patients, with invasion of brachial plexus and subclavian

1 - Hospital das Clínicas Samuel Libânio, Serviço de Cirurgia Cardiotorácica, Pouso Alegre, MG, Brasil. Rev Col Bras Cir 2017; 44(6): 655-658


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vessels (Figure 6). Region is delimited with metallic clips to orientate adjuvant therapy.

Figure 4. Progressive reduction of tumor mass.

Figure 1. Giant tumor of posterior mediastinum.

Figure 5. Tumor mass removed.

Figure 2. Giant tumor of antero-superior mediastinum.

Figure 6. Malignant tumor invading brachial plexus.

DISCUSSION

Figure 3. Tumor lamination with thermal-cautery.

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major part of thoracic cavity, preventing surgical maneuvers necessary for mobilization and tumor removal. Also, the involvement of surrounding major structures and tumor vascularization may justify the need of exceptional maneuvers, without which the patient would be considered inoperable4. Among proposed solutions, aspiration of tumor content, lowering its volume, cannot be used in solid tumors and is restricted to cystic tumors. Also, it was proposed embolization of vascular pedicles and the use of extracorporeal circulation, to reduce bleeding and ease tumor removal, but with unsatisfactory results4. Video-thoracoscopic resection does not replace open approach of giant tumors, since the lack of enough space to move surgical instruments impairs vision, and although new and promising, this technique should only be used in the treatment of small lesions5. Bilateral thoracotomy with transverse section of sternum (“clamshell operation”) was also proposed. Although allowing for a broad vision of surgical field, it has some disadvantages such as increase of surgical trauma and consequent increase of complications incidence.

There is no consensus regarding clinical criteria to define a giant mediastinal tumor. It is considered giant when occupies more than half of one hemithorax. In spite of different locations, once the diagnosis is stablished, surgical treatment is mandatory6. This is a very difficult topic with tricky solutions, and it is justified the search for new techniques to help surgeons. The technique presented here ease removal of giant mediastinal solid tumors, and may be used with any incision, independent of the location. Once exposed, the lesion is resected with the aid of a routine instrument available for major thoracic surgeries. We used the procedure in four patients (two with malignant tumors and two with benign tumors), with good early post-operatory evolution. Only one patient died at the 30th day of post-operatory, due to pulmonary embolism. The other patient with malignant tumor is still alive under oncologic treatment. Both patients with benign disease are alive and asymptomatic. We conclude that tumor lamination technique is a valid alternative for resection of solid giant mediastinal tumors, allowing the removal of giant tumors without the need of exceptional maneuvers.

R E S U M O Tumores do mediastino podem crescer lentamente e atingir proporções gigantes sem apresentar sintomas, tornando a remoção cirúrgica problemática. As dimensões exacerbadas da neoplasia dificultam as manobras cirúrgicas, com risco de hemorragia incontrolável e comprometimento de estruturas adjacentes, levando à utilização de medidas de exceção, como a derivação circulatória veno-venosa, a embolização pré-operatória e a circulação extracorpórea total. Diante disto, descrevemos a técnica de laminação tumoral, que permite a ressecção total ou quase total de tumores considerados, muitas vezes, irressecáveis, tendo por base os resultados alcançados em quatro pacientes portadores de neoplasias gigantes do mediastino. Descritores: Cirurgia Torácica. Neoplasias do Mediastino. Procedimentos Cirúrgicos Operatórios.

REFERENCES 1.

2.

3.

by video-assisted thoracoscopic surgery. Ann Thorac Surg. 2015;100(2):698-700.

Mani VR, Ofkwu G, Safavi A. Surgical resection of a giant primary liposarcoma of the anterior mediastinum. J Surg Case Rep. 2015;2015(9). pii: rjv126. Zaho H, Zhu D, Zhou Q. Complete resection of a giant mediastinal teratoma occupying the entire rigth hemithorax in a 14-year-old boy. BMC Surg. 2014;(14):56-8. Makdisi G, Roden AC, Shen RK. Successful resection of giant mediastinal lipofibroadenoma of the thymus

4.

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6.

Aydemir B, Çelik S, Okay T, Doğusoy I. Intrathoracic giant solitary fibrous tumor. Am J Case Rep. 2013;14:91-3. Wang J, Yan J, Ren S, Guo Y, Gao Y, Zhou L. Giant neurogenic tumors of mediastinum: report of two cases and literature review. Chin J Cancer Res. 2013;25(2):259-62. Yang C, Zhao D, Zhang P, Fei K, Jiang G. Intrathoracic neurogenic tumor with malignant transition-20 years

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operation experience in a medical center of China. Neurosci Lett. 2017;(637):195-200. Received in: 31/08/2017 Accepted for publication: 07/09/2017 Conflict of interest: none.

Source of funding: none. Mailing address: Elias Kallas E-mail: eliaskallas@uol.com.br/ clinicakallas@clinicakallas. com.br

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Technical Note

DOI: 10.1590/0100-69912017006008

Punch grafts to treat lower limb intractable sores “Punch grafts” nas úlceras de membros inferiores de difícil tratamento

JÚLIO WILSON FERNANDES, TCBC-PR1; RAFAEL SONODA AKAMINE2; EDUARDO CASTILHO CASAGRANDE1.

A B S T R A C T Lower limb recurrent ulcers, usually caused by prolonged decubitus, trauma, diabetes or burns, may not heal with conventional clinical or surgical treatment. Frequently, laminated skin grafts do not integrate with the recipient layer, and the only alternatives are neighbor microsurgical flaps. These have higher morbidity and create secondary defects, to be corrected with skin grafts, when fasciocutaneous or miocutaneous segments are removed for the treatment of the primary defect. We describe the non-conventional use of punch grafts in the treatment of lower limb ulcers, when conventional skin laminated graft failed, without the use of flaps. Since this is a very successful technique, its use should be considered as a valuable alternative for the treatment of recurrent lower limb ulcers. It is a simple and easy-learned technique that may be used by different surgeons, even in remote places without correct specialized hospital facilities. Keywords: Skin Transplantation. Leg Ulcer. Biological Dressings.

INTRODUCTION

L

ower limb deep ulcers usually do not heal, regardless the cause, and in most occasions are related to diabetes, trauma or burns. Best treatment depends on correct initial diagnosis and of etiological origin1. In our country, non-surgical treatments, very popular, use expensive charcoal, silver and hydrocolloid dressings2. Any cutaneous lesion is subjected to epithelization phenomena and centripetal contraction due to miofibroblasts action3. This physiological response to trauma is not adequate to bigger ulcers, since it causes incomplete closure of the defect and/or covering with fragile epithelium, that usually harbors new ulcers, in-

fection, and in rare cases, development of squamous cell carcinoma, as it is observed in Marjolin ulcers4. The treatment of these lesions, when clinical management is unsatisfactory, usually is the use of laminated partial graft skin. Most times these grafts don’t integrate or don’t repair satisfactorily the defect, and, for that reason, it is necessary to use more complex reconstruction techniques with neighbor fasciocutaneous, muscular, miocutaneous or microsurgical cutaneous flaps. These are more technically challenging, with higher morbidity, risks and hospitalization time1. Punchs are cut surgical instruments, that include a handle and a cylindrical tube, with cutting edge5. They are frequently used in Dermatology, particularly for biopsies of skin lesions. For biopsy, the

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use of punchs are justified by the nature of the lesion, determining the correct diameter to be used6, from 2mm to 10mm5. In Plastic Surgery, their higher use was observed in the first surgical procedures to treat baldness: ten to 20 grouped hair follicles with 3mm to 4mm were transplanted. They were soon abandoned and replaced by micrografts: one to four hair follicles are transplanted, with a more natural result in relation to the artificial aspect of patients submitted to punchs7. Their use as skin grafts is extremely rare in literature. We describe the unconventional use of punch grafts for skin transplantation, as a safe, simple and useful alternative to skin grafts, without the inconveniences of laminated partial skin grafts.

THECNICAL NOTE We use regular punchs, disposable or reusable, with large diameter (6 to 8 mm in diameter). Under local or spine anesthesia and eventual sedation, the ulcer is adequately washed and superficially debrided. After antisepsis, an area preferably at a sulcus or a flexion fold is infiltrated with 0.4% lidocaine with 1:200.000 adrenalin. After 15 minutes for correct adrenaline hemostasis, the punchs are applied with rotation movements including the subcutaneous, collecting several punch grafts (Figure 1A). Using the same instrument, several perforations are made at the ulcer, with approximately 0.5cm between each hole, discarding the tissue removed (Figure 1B). With the aid of a delicate forceps, the punchs, one by one, are inserted in each perforation (Figure 1C). If necessary, fat excess of the deep part of the punch graft may be excised before insertion. It is important to perform all perforations at the ulcer before starting the insertion of punch grafts, to avoid their extrusion caused by the more vigorous movement to make each perforation (Figure 2). A gauze with antiseptic cream is applied in the treated area and a compressive Brown dressing ends the procedure. The holes at the donor area are closed with â&#x20AC;&#x153;Uâ&#x20AC;? stiches of 4-0 nylon (Figure 1D). After ten days, the dressing is removed, and it is observed a whitish aspect of the visible surface of punch grafts (Figure 1E). After approximately three weeks, the punch grafts accrete and repair adequately the defect (Figure 1F).

We exemplify the technique used in two of our patients. One had a diabetic foot amputated, that was previously submitted to two partial skin grafts without success. In that corporal segment, the use of flaps depends on the localization, depth and extension of lesion, vascularization and particularly receptor area function: if it has to bear weight in the region8. The use of special footwear by a patient who lost distal part of foot requires underlying good quality and mechanically resistant tissues, to avoid ulcers, infection, or osteomyelitis1. The use of microsurgical flap could be considered, but the concurrent diabetic vasculopathy could compromise morbidity, associated to particular risks and technical difficulties of microsurgical transplantation8. Figures 2 and 3 show surgery and final results.

Figure 1. A-F) Punch grafts for the treatment of ischiatic ulcer.

Figure 2. Punch grafts to treat diabetic foot ulcer: operatory time.

The other patient was a martial arts professional, with rupture of calcaneous tendon. He was

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submitted to tenorraphy, but developed a bothersome local fibrosis, treated with radiotherapy. Thirty years later, after using a tight shoe, he developed a deep and extensive ulcer at the region, with partial exposure of calcaneous tendon (Figure 4). He was submitted to non-surgical treatment with different dressings, without healing. Partial laminated skin grafts obtained

Figure 3. Post-operatory of punch grafts treatment of diabetic foot ulcer.

Figure 5. Treatment of calcaneous ulcer with punch grafts: post-operatory.

from the tight, inserted twice, were unsuccessful and required two skin graft surgical procedures. Classically, for the posterior region of calcaneous, it is recommended the use of bilobed cutaneous grafts, reverse sural artery grafts, reverse fibular artery grafts, island flaps of the dorsum of the foot, and, in more severe cases, microsurgical flaps8. Patient did not agree with local flap, due to sensitivity and vulnerability of donor area, and other possible limitations of the professional or sportive use of the affected lower limb. Figures 4 and 5 show pre- and post-operatory technique using punch skin grafts, and the healing of the treated defect.

DISCUSSION

Figure 4. Deep ulcer at the calcaneous: pre-operatory.

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ver cutaneous defects that could not be treated by direct approximation of borders and correct suture, without flanges or scars that harm limb movement. The more distal the lower limb defect, the lowest is the skin availability for advance and primary suture; therefore, skin grafts are very important to repair trauma and burn defects of lower limb and feet. However, in order to succeed, grafts should be applied in a trophic receptor bed, to ensure correct lymphatic soaking of graft and capillary neovascularization. Immobilization of graft for seven to 10 days is also important for success. In deep lesions, the presence of tendons without epitendons, of bone without periosteum or prothesis exposure, skin grafts are not indicated, even with the advent of vacuum dressings, that occasionally stimulate tissue granulation, favoring graft integration 8. Partial skin grafts integrate more easily than total skin flaps, but in regions of friction or weight support, they may be not as successful, particularly in labor aged people that regularly use shoes or slippers continuously 9. When skin grafts fail, the alternatives include cutaneous, fasciocutaneous and miocutaneous flaps. Most skin flaps do not present specific vascularization, and muscle and skin arteries are responsible for irrigation. These are connected to dermic and subdermal plexus. These flaps have reduced dimensions and many times require autonomization. A lesion of the subdermal plexus may cause partial or total loss of skin flap 10. In view of the skin smallness and precarious cutaneous vascularization, lower limb frequently requires the use of fasciocutaneous, muscular (solium and gastrocnemius) flaps, followed by skin graft, or miocutaneous flaps, such as the fascia lata tensor muscle to correct trochanteric region defects, and hock muscles (Horteau) for correction of ischiatic region defects. Fasciocutaneous flaps include skin, subcutaneous tissue and deep fascia, excluding muscle. They may be of axial or random types. Fasciocutaneous flaps safety is based on the rich vascularization of deep fascia. Another advantage is the low incidence of functional defects 11. Muscular flaps may feel deep spaces, and due to their rich capillary

net, they facilitate the deposition of antibiotics in tissues. These flaps respond more promptly to bacterial colonization and infections, and also facilitate fast deposition of collagen and growth 12. Miocutaneous flaps have many particular qualities that ensure distinct advantage to be applied in lower limbs; they include several layers (skin, subcutaneous, fascia and muscle), providing volume, and a good reliability of vascular pedicle. One of the problems is muscular function harm 13. All these flaps require major surgeries, and cause a secondary defect at the donor area, frequently repaired by direct closure, V-Y mobilization or skin transplantation. With higher surgical complexity and risks, microsurgical flaps, such as the forearm â&#x20AC;&#x153;Chinese flapâ&#x20AC;? (pedicle in the radial artery) used to correct a diabetic foot amputation stump, or the miocutaneous flap of major dorsal muscle, to correct extensive loss of tissue of gluteus and trochanteric regions, may be used 11. The use of punch grafts is proposed by the authors to be preferably used when special dressings and laminated partial skin grafts are unsuccessful, and when the above mentioned flaps were not used due to morbidity and risks, and/or aesthetic and functional damages of donor area. The use of punch grafts brings to the ulcer a complete skin segment with subcutaneous, dermis, appendices and epidermis. Due to their deep insertion, they are immobilized and protected, with lymphatic soaking and deep ulcer vascularization, favoring integration. On the contrary to laminated skin graft, some units may be lost and not all partial skin transplanted, as occasionally observed in difficult recurrent lower limb ulcers, submitted to the classic laminar technique. Skin punch grafts use has been successfully reported by veterinarians, to treat race horse paws, with 60% to 95% of success 14.

CONCLUSION The old and frequently forgotten punch grafts are an efficient, simple, cheap and easy alternative for the treatment of recurrent lower limb

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ulcers. Their use has been successful, when laminar skin flaps had failed, and may prevent the use of

more complex and with higher morbidity techniques, such as local and microsurgical flaps.

R E S U M O As ulcerações recidivantes de membros inferiores, decorrentes de decúbito prolongado, trauma, diabetes ou queimaduras, podem não responder adequadamente aos tratamentos convencionais, clínicos e cirúrgicos. Frequentemente, nestes casos, enxertos de pele laminada não se integram ao leito receptor, deixando o uso de retalhos de vizinhança e microcirúrgicos como únicas alternativas. Estes retalhos implicam em maior morbidade e criam defeitos secundários, a serem reparados por enxertos de pele, após fornecerem o segmento cutâneo, fasciocutâneo ou miocutâneo para o tratamento do defeito primário. Descrevemos o uso não convencional de enxertos em punch (“punch grafts”) no tratamento de ulcerações de membros inferiores, em situações em que a enxertia de pele laminada convencional não teve sucesso e retalhos não foram empregados. Pelo êxito desta técnica, seu uso deve ser considerado como uma valiosa alternativa no tratamento de úlceras recidivantes de membros inferiores. Sendo uma técnica simples e de fácil aprendizado, pode ser empregada por cirurgiões de diferentes especialidades, mesmo em locais remotos, onde inexistam as facilidades de um centro médico-hospitalar especializado. Descritores: Úlcera da Perna. Curativos Biológicos. Transplante de Pele.

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Sarkar PK, Ballantyne S. Management of leg ulcers. Postgrad Med J. 2000;76:674-82. Purser K. Wound dressing guidelines. Royal United Hospital Bath NHS Trust. 2007;747:2007. Darby IA, Laverdet B, Bonté F, Desmoulière A. Fibroblasts and myofibroblasts in wound healing. Clin Cosmet Investg Dermatol. 2014;7:301-11. Fazeli MS, Lebaschi AH, Hajirostam M, Keremati MR. Marjolins Ulcer: Clinical and pathologic features of 83 cases and review of literature. Med J Islam Repub Iran. 2013;27(4):215-24. Lourenço EA, Almeida CIR, Tucori JN, Menuzzi MA, Marcondes LGC. Utilização do “punch” em biópsias da mucosa oral. Braz J Otorhinolaryngol. 1984;50(2):17-20. Werner B. Biópsia de pele e seu estudo histológico. Por quê? Para quê? Como? Parte II. An Bras Dermatol. 2009;84(5):507-13. Limmer BL. Elliptical donor stereoscopically assisted micrografting as an approach to further refinement in hair transplantation. Dermatol Surg. 1994;20(12):789-93 apud Avram M, Rogers N,

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Contemporary hair transplantation. Dermatol Surg. 2009;35(11):1705-19. Marsh JL, Perlyn CA. Decision Making in Plastic Surgery. St. Louis, Missouri: Quality Medical Publishing, 2010. Tilkorn H, Drepper H, Hundeiker M. Problems in surgery of the sole of the foot. Z Hautkr. 1990;65(6):550-2, 555. Converse JM. Reconstructive Plastic Surgery: Principles and Procedures in Correction, Reconstruction and Transplantation. 2a ed. Philadelphia: W.B. Saunders Company; 1977. Hochberg J. Manual de Retalhos Miocutâneos: Axiais, Osteomiocutâneos, Fasciocutâneos e Livres. Porto Alegre: AMRIGS, 1984. Klebuc M, Menn Z. Muscle flaps and their role in limb salvage. Methodist Debakey Cardiovasc J. 2013;9(2):95-9. Gusmão LCB, Lima JSB, Duarte FHG, Souto AGF, Couto BMV. Bases anatômicas para utilização do músculo fibular terceiro em retalhos miocutâneos. Rev Bras Cir Plást. 2013;28(2):191-5. Wilmink JM, van den Boom R, van Weeren PR, Barneveld A. The modified Meek technique as a

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Fernandes Punch grafts to treat lower limb intractable sores

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novel method for skin grafting in horses: evaluation of acceptance, wound contraction and closure in chronic wounds. Equine Vet J. 2006;38(4):324-9. Received in: 19/07/2017 Accepted for publication: 23/08/2017

Conflict of interest: none. Source of funding: none Mailing address: Julio Wilson Fernandes E-mail: cirurgiaplasticajwf@uol.com.br / jwf@uol.com.br

Rev Col Bras Cir 2017; 44(6): 659-664


Erratum

DOI: 10.1590/0100-69912017006016

I

n September/October 2017, the Journal of the Brazilian College of Surgeons (Rev Col Bras Cir. 2017;44(5):530-44) published the original article titled “A proposal of Brazilian Society of Surgical Oncology for standardizing cytoreductive surgery plus hypertermic intraperitoneal chemotherapy procedures in Brazil: pseudomixoma peritonei, appendiceal tumors and malignant peritoneal mesothelioma.” (http://dx.doi.org/10.1590/0100-69912017005016), by Thales Paulo Batista; Bruno José Queiroz Sarmento; Janina Ferreira Loureiro; Andrea Petruzziello; Ademar Lopes; Cassio Cortez Santos; Cláudio de Almeida Quadros; Eduardo Hiroshi Akaishi; Eduardo Zanella Cordeiro1; Felipe José Fernández Coimbra; Gustavo Andreazza Laporte; Leonaldson Santos Castro; Ranyell Matheus Spencer Sobreira Batista; Samuel Aguiar Júnior; Wilson Luiz Costa Júnior; Fábio Oliveira Ferreira; Comitê de Neoplasias Peritoneais e Quimioterapia Intraperitoneal Hipertérmica da Sociedade Brasileira de Cirurgia Oncológica. The following errors were identified: Title: Reads: “A proposal of Brazilian Society of Surgical Oncology for standardizing cytoreductive surgery plus hypertermic intraperitoneal chemotherapy procedures in Brazil: pseudomixoma peritonei, appendiceal tumors and malignant peritoneal mesothelioma”; Should read: “A proposal of Brazilian Society of Surgical Oncology (BSSO/SBCO) for standardizing cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) procedures in Brazil: pseudomixoma peritonei, appendiceal tumors and malignant peritoneal mesothelioma.”.

Authors: Reads: “Thales Paulo Batista; Bruno José Queiroz Sarmento; Janina Ferreira Loureiro; Andrea Petruzziello; Ademar Lopes; Cassio Cortez Santos; Cláudio de Almeida Quadros; Eduardo Hiroshi Akaishi; Eduardo Zanella Cordeiro1; Felipe José Fernández Coimbra; Gustavo Andreazza Laporte; Leonaldson Santos Castro; Ranyell Matheus Spencer Sobreira Batista; Samuel Aguiar Júnior; Wilson Luiz Costa Júnior; Fábio Oliveira Ferreira; Comitê de Neoplasias Peritoneais e Quimioterapia Intraperitoneal Hipertérmica da Sociedade Brasileira de Cirurgia Oncológica” Should read: “Thales Paulo Batista; Bruno José Queiroz Sarmento; Janina Ferreira Loureiro; Andrea Petruzziello; Ademar Lopes; Cassio Cortez Santos; Cláudio de Almeida Quadros; Eduardo Hiroshi Akaishi; Eduardo Zanella Cordeiro1; Felipe José Fernández Coimbra; Gustavo Andreazza Laporte; Leonaldson Santos Castro; Ranyell Matheus Spencer Sobreira Batista; Samuel Aguiar Júnior; Wilson Luiz Costa Júnior; Fábio Oliveira Ferreira; on behalf of the BSSO/ SBCO Committee on Peritoneal Surface Malignancies and HIPEC” Abstract: Reads: “hypertermic” Should read: “hyperthermic”

Rev Col Bras Cir 2017; 44(5): 655


INSTRUCTIONS FOR AUTHORS SCOPE AND POLITICS The Journal of the Brazilian College of Surgeons (CBC), an official division of the CBC, is published bimonthly in one annual volume, and proposes the dissemination of articles of all surgical specialties, contributing to its teaching, development and national integration. Articles published in the Journal of the Brazilian College of Surgeons follow the uniform requirements recommended by the International Committee of Medical Journals Editors (ICMJE – www.icmje.org), and are submitted to a double blind peer review. The journal of the Brazilian College of surgeons supports the policies for registration of clinical trials of the World Health Organization (WHO) and the ICMJE, recognizing the importance of these initiatives for the record and international dissemination of information on clinical studies in open access. Thus, it will only accept for publication the clinical research articles that have received an identification number on a clinical trial registry validated by the criteria established by WHO and ICMJE. The identification number must be registered at the end of the abstract. Between three and five members of the Editorial Board, anonymous to the authors, receive the texts, also anonymously, and decide for their publication. In the event of conflict of opinions, the Director of publications will evaluate the need for a new appraisal. Rejected articles are returned to authors. Only the works within the journal’s publication standards will be submitted to evaluation. Approved articles may sustain editorial-type alterations, provided that they do not alter the merit of the work. GENERAL INFORMATION The Journal of the Brazilian College of Surgeons evaluates articles for publication in Portuguese (Brazilian authors) and English (foreign authors) that follow the rules for manuscripts submitted to biomedical journals prepared and published by the International Committee of Medical Journal Editors (ICMJE – www.icmje.org) [CIERM Rev Col Bras Cir. 2008; 35 (6): 425-41, or article on the website of the journal (www.revistadocbc.org.br)] with the following characteristics: • Editorial: Is the initial article of an issue, generally about a current subject, requested by the Editor to the author of recognized technical and scientific capacity. • Original Article: Is the full account of clinical or experimental research, with positive or negative results. It must consist of Abstract, Introduction, Methods, Results, Discussion and References, the latter limited to a maximum of 35, aiming to the inclusion, whenever possible, of articles from national authors and national journals. The title should be written in Portuguese and English, and should contain the maximum of information with the minimum of words, without abbreviations. It must be accompanied by the complete name(s) of author(s) followed by the name(s) of the institution(s) where the work was performed. If multicenter, Arabic numerals must indicate the provenance of each of the authors in relation to the listed institutions. Authors should send along with their names only one title and one that best represents their academic activity. The Abstract should have a maximum of 250 words and be structured as follows: objective, methods, results, conclusions and keywords in the form referred to by DeCS (http://decs.bvs.br ). • Review article: The Editorial Board encourages the publication of matters of great interest to the surgical specialties containing synthetic analysis and relevant criticism and not merely a chronological description of literature. I must contain an introduction with description of the reasons that led to the writing of the article, the search criteria, followed by text ordered in titles and subheadings according to the complexity of the subject, and unstructured abstract. When applicable, at the end there may be conclusions and opinions of authors summarizing the review contents. • Letters to the Editor: Scientific Comments or controversy regarding articles published in the journal of the CBC. In general, such letters are sent to the principal author of the article to response and both letters are published in the same journal issue, no replica being allowed. • Scientific Communication: Content that deals with the form of presentation of scientific communication, investigating the problems and proposing solutions. Due to its features, this section can be multidisciplinary, receiving contributions from doctors, surgeons and non-surgeons and other professionals from various areas. It must have an unstructured Abstract, Keywords and free text. • Technical Note: Information about a particular operation or procedure of importance in surgical practice. The original must not exceed six pages including pictures and references if necessary. It must have an unstructured Abstract, Keywords and free text. • Education: Freeform content that addresses the teaching of surgery, both in graduate and post-graduate levels. Unstructured abstract. • Bioethics in surgery: Discussion of bioethical aspects in surgery. The content should address bioethical dilemmas in the performance of surgical activity. Freeform. Unstructured abstract. • Case reports: May be submitted for evaluation and the approved reports will be published, mainly in electronic journal of case reports, the Journal of Case Reports of the Brazilian College of Surgeons which can be accessed through the Brazilian College of Surgeons’ website (www.cbc.org.br) or directly at www.relatosdocbc.org.br. ARTICLE SUBMISSION Sending articles for the Journal of the Brazilian College of Surgeons can only be done through the online platform for submission of scientific papers, which can be accessed through the Brazilian College of Surgeons’ website (www.cbc.org.br) or directly at www.rcbc.gnpapers.com.br.

FORM AND STYLE • Text: Manuscripts submitted for review by the Journal of the Brazilian College of Surgeons must be unpublished and should not be evaluated in whole or in part by another scientific journal. Images should be forwarded separately from the text, and in accordance with the instructions on the online submission platform. Articles should be concise, not exceeding 2500 words. The abbreviations should be as few as possible, limited to the terms mentioned repetitively, as long as they do not hinder the understanding of the text, and should be defined from the first use. • References: Must be predominantly of works published in the last five years, restricted to those cited in the text, in order of citation, numbered consecutively and presented according to the Vancouver format (rules for manuscripts submitted to Biomedical Journals ICMJE- www.icmje.org – CIERM Rev Col Bras Cir. 2008; 35 (6): 425-41-www. revistadocbc.org.br). Annals of congresses and personal communications will not be accepted as references. Citations of books and theses should be discouraged. The authors of the article are responsible for the accuracy of the references. • Acknowledgements: Should be made to people who importantly contributed to the work’s realization. TABLES (maximum of six) Tables should be numbered with Arabic numerals, with captions on the top containing one or two sentences, and explanations of symbols at the bottom. Cite the tables in the text in numerical order including only information necessary for understanding of important points of the text. The data presented should not be repeated in graphs. Tables should follow the above-mentioned Vancouver standards. Tables must be typed in the body of the text, and never sent as figures. FIGURES (maximum of six) Figures are all the photos, graphics, paintings and drawings. All figures must be referred to in the text, being numbered consecutively by Arabic numbers and accompanied by descriptive captions. Histological images should contain in the legends the histological technique used and the degree of magnification. All figures should be submitted separately at the end of the manuscript.

MANDATORY CONDITIONS (READ CAREFULLY) It is expressed that, with the electronic submission, the author (s) agree (s) with the following assumptions: 1) that there is no conflict of interests, compliant with the Brazilian Federal Council of Medicine (CFM) resolution No. 1595/2000 that prevents the publication of works and materials with promotional purposes of products and/or medical devices; 2) that one must cite the funding source, if any; 3) that the work was submitted to the respective Ethics in Research Committee which approved it, providing the aproval number in the text; 4) that all authors authorize that the article suffer changes in the submitted text to be standardized in the language format of the Journal, which can result in removal of redundancies, as well as tables and/ or figures that are deemed unnecessary to understanding the text, provided that it does not change its meaning. If there are disagreements of the authors about these assumptions, they should write a letter leaving explicit the point at which they disagree, which will be appraised by the Editor, who will decide whether the article can be forwarded for publication or returned to the authors. 5) that the authors are allowed to hold the copyright of their published work without restrictions. 6) that if there is conflict of interest, it should be quoted with the text: “the author (s) (provide names) received financial support of the private company (provide name) for this study”. When there is a research foment funding source, it must also be cited. 7) that the responsibility for concepts or statements issued on articles and announcements published in the Journal of the Brazilian College of Surgeons is entirely up to the author (s) and advertisers. 8) that works already published or simultaneously submitted for evaluation in other periodicals will not be accepted. 9) that each approved article will have a cost of R$ 1,000.00 (one thousand reais) for the authors. If the lead author is a member of the Brazilian College of Surgeons, there will be a 50% discount on the article’s fee. Case Reports, approved for publication in the Journal of Case Reports of the Brazilian College of Surgeons are exempt from charges.

CONTACT: 2016-Brazilian College of Surgeons Rua Visconde de Silva, 52-3the floor 22271-090-Rio de Janeiro-RJ-Brazil Tel: + 55 21 2138-0659 Fax: + 55 21-2286 2595 Address for submission of manuscripts: E-mail: revistacbc@cbc.org.br


ABOUT THE JOURNAL Basic information Objectives: To disseminate scientific works of the surgical area of medicine that contribute to its teaching and development. History: The publication and dissemination of scientific activities of its members is one of the aims of medical societies. The Brazilian College of Surgeons (Colégio Brasileiro de Cirurgiões – CBC), founded in 1929, already in its first statute provided for the issuance of the “Bulletin of the Brazilian College of Surgeons” as its official division, whose starting number was published in January 1930. In 1967, the National Directory of CBC changed its name to “Journal of the Brazilian College of Surgeons”. From 1974 on, the journal began to be published bi-monthly, on a regular basis, to the present day. The abbreviation for its title is Rev Col Bras Cir, which should be used in bibliographies, footnotes and in references and bibliographic legends.

Creative Commons The journal of the Brazilian College of Surgeons is licensed with a 4.0 International , non-commercial, Creative Commons Attribution. This license lets others remix, adapt and create from your work, for non-commercial purposes. Although the new works have to assign proper credit and may not be used for commercial purposes, users do not have to license these derivative works under the same terms.

Free access policy This journal provides free and immediate access to its content, following the principle that providing free scientific knowledge to the public provides greater democratization of world knowledge.

About APC (Article Processing Charges) In view of the high costs for publication of the journal, from the issue 1/2017 on, every approved article started to have a cost of R$ 1000.00 (1000 reais) for the authors. Articles in which the lead author is a member of the CBC will have a discount of 50% of the publication fee.

Anti-Plagiarism Policy The Journal of the Brazilian College of Surgeons uses the iThenticate program to identify plagiarism in articles submitted for publication.

Indexing sources • Latindex • LILACS • Scopus • DOAJ • Free Medical Journals • MEDLINE/PUBMED • SciELO

Intellectual property All journal content, except where otherwise stated, is licensed under a Creative Commons License of type CC-BY attribution.

Sponsors The Journal of the Brazilian College of Surgeons is sponsored by CBC through: • Annuity of its associated members • Money from advertisers • Article publication fee


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