General Surgery News ( December 2020 )

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

December 2020 • Volume 47 • Number 12

Should Surgical Residents Unionize?

Debate Pits Benefits of Advocacy Against the Drawbacks wbacks of an Adversarial Culture

By MONICA J. SMITH

I

s resident unionization the strongest form of advocacy forr a vulnerable population, or is it an inappropriate mode of selfelfprotection with an erosive effect on the medical profession?

“This polarizing debate has become even more intense in the setting of the COVID-19 pandemic,” said Julia R. Coleman, MD, MPH, a general surgery resident at the University of Colorado rado Denver Anschutz Medical Campus.

Surgical residents have long faced a number of stressors, rs, including job market uncertainty, work–life imbalance, medi-cal school debt, and salaries that don’t keep up with the cost st of living. The coronavirus pandemic has added new concerns, s, such as access to personal protective equipment and adequate ate sick leave.

“Residents are asking themselves again, ‘What is our bestt mechanism for advocacy?’” said Dr. Coleman, the chair of the Advocacy dvocacy and Issues Committee of the Resident and Associate Society of the American College of Surgeons (RAS-ACS), who introduced a debate on the topic at the

Surgeons Can Do Mor More to ‘Prehab,’ Reh Rehab Patients

By KAREN BLUM

S

urgeons have been gradually adopting methods to optimize patients before surmethod gery and be better help them recover, but there is still room for improvement, experts said at the Society Soc of American Gastrointestinal and Endoscopic En Surgeons 2020 annual meeting, he held virtually this year.

One question que that remains today is how to improve quality qu in surgery, said Dana Telem, MD, MPH MPH, the division chief of minimally invasive an and bariatric surgery, and vice chair for quality and patient safety, at the University of M Michigan, in Ann Arbor.

“Oftentimes we talk about improving “Oft technique in perioperative care, but we techni

Continued on page 8

Continued on page 22

OPINION

Reproductive Hazards As a Surgeon: Reducing Risk

Community Practice: Surgeons Share What’s Not Taught in Training

Metabolic Surgery In the Era of COVID-19

By ALISON McCOOK

By CHRISTINA FRANGOU

By HENRY BUCHWALD, MD, PhD

T

S

W

here are risks that accompany a career in surgery. For example, studies have shown that female surgeons have higher rates of infertility and pregnancy complications, and not just because surgeons tend to have babies later in life (JAMA Surg 2020;155[3]:243-249).

Female surgeons face various reproductive hazards present in all medical specialties, such as injuries from sharps or infections from patients, said Aleksandra Szczęsna, a sixth-year medical student at the Medical University of Warsaw, in Poland, who has studied this topic (Ginekol Pol 2019;90[8]:470-474). There’s

urgeons spend years training at academic centers to learn the art and science of surgery, but this model leaves them ill prepared for managing the business of surgery at a community practice.

“The lack of exposure to community practice in training doesn’t necessarily prepare graduates to be successful,” said Laura Doyon, MD, a general surgeon at Emerson Hospital in Concord, Mass., speaking at the virtual 2020 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

During a panel on community practice, four surgeons shared their experiences.

Continued on page 17

IN THE NEWS

Continued on page 18

PRODUCT SPOTLIGHT

4 Highlights From the 2020 ACS Clinical Congress CL INICAL REVIEW

10 The Way of the Wound T H E GREAT DEBATES

12 Avoiding Bile Duct Injury During Lap Chole facebook.com/generalsurgerynews

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OPINION

DECEMBER 2020 / GENERAL SURGERY NEWS

Starting Nov. 2, 2020, all patients in the United States will have immediate access to all clinical notes, and thus will be able to read their doctors’ writings and dictations, as well as all laboratory, pathology and imaging reports.

Mind Your P’s and Q’s

By FREDERICK L. GREENE, MD B

“M

ind your P’s and Q’s” is an English-language expression meaning “mind your manners,” “mind your language,” “be on your best behavior” and “watch what you’re doing.” Early examples of the use of P’s and Q’s may be a reference to learning the alphabet. An early allusion is found in a poem by Charles Churchill, published in 1763: “On all occasions next the chair / He stands for service of the Mayor / And to instruct him how to use / His As and Bs, and Ps and Qs.” A number of alternative explanations have been considered as more or less plausible. One suggests that P’s and Q’s is short for “pleases” and “thank yous,” the latter of which contains a sound similar to the pronunciation of the name of the letter Q. Another proposed origin comes from the English pubs and taverns of the 17th century. Bartenders would keep watch on the alcohol consumption of the patrons, keeping an eye on the “pints” and “quarts” that were consumed. As a reminder to the patrons, the bartender would recommend they “mind their P’s and Q’s.”

You are probably wondering what this idiomatic expression has to do with anything relevant to our erudite General Surgery News readership. Let me refer you to the 21st-century Cures Act and some provisions that took effect just this past November. The Cures Act is responsible for the implementation of key provisions that are designed to “advance interoperability; support

the access, exchange and use of electronic health information (EHI); and address occurrences of information blocking.” This federal rule also mandates that patients have access to their EHI in a form “convenient for patients, such as making a patient’s EHI more electronically accessible through the adoption of standards and certification criteria and the implementation of information blocking policies that support patient electronic access to their health information at no cost.” In plain English, it means that starting Nov. 2, 2020, all patients in the United States will have immediate access to all clinical notes, and thus will be able to read their doctors’ writings and dictations, as well as all laboratory, pathology and imaging reports.

The law means that inpatient and outpatient notes will be released without delay and that patients will have immediate access to testing and imaging results, including results from sexually transmitted disease tests, Pap tests, cancer biopsies, CT and PET scans, fetal ultrasounds, pneumonia cultures and mammograms. This federal mandate, called “open notes” by many, is potentially perplexing and frightening for patients. For example, the term SOB may not be intuitively obvious that it stands for “shortness of breath”! Obviously, the perusal of medical information by patients, families and caregivers without the accompanying counsel of the patient’s clinician is tantamount to “surfing the web,” trying to make sense of unfamiliar information.

Traditionally, medical record notes have served as a conduit of information between and among clinicians MISSION STATEMENT OF GSN It is the mission of General Surgery News to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons.

Senior Medical Adviser Frederick L. Greene, MD Charlotte, NC

Lauren A. Kosinski, MD Chestertown, MD

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Marina Kurian, MD New York, NY

DISCLAIMER Opinions and statements published in General Surgery News are of the individual author or speaker and do not represent the views of the editorial advisory board, editorial staff or reporters.

Raymond J. Lanzafame, MD, MBA Rochester, NY

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and have been important repositories of information to provide a reasonable chronology of a patient’s course through treatment. An additional practical use has been for the accurate coding and billing of patient care. These foundational uses of patients’ records will undoubtedly still hold true. The issue that I am highlighting, however, is that clinicians and all health care institutions have a greater audience for seamless viewing of the entire health record—namely the patient.

It is patently obvious that even without federal mandates, clinicians should endeavor at all times to enter notes that are clear, factual and composed in a thoughtful manner for all those destined to read them.

The other important message is to refrain from taking for granted that your notes actually have conveyed your true account of your patients’ clinical encounters.

Think about those times that you have written a text, an email message or a social media comment which, when reviewed, had no semblance to your actual intent! Clinical notes and especially operative reports must be considered in the same light. Every patient dictation and entry in the electronic health record must be reviewed for accuracy, truthfulness and sensitivity. This will be a good practice for all of us and should not just result as a consequence of routine patient review. Yes, the time is really nigh to mind our P’s and Q’s.

■ —Dr. Greene is a surgeon in Charlotte, N.C.

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IN THE NEWS

GENERAL SURGERY NEWS / DECEMBER 2020

Highlights From the American College of Surgeons Clinical Congress The first-ever virtual American College of Surgeons Clinical Congress convened Oct. 3-7, 2020.

Here, General Surgery News presents highlights from the scientific forum.

By CHRISTINA FRANGOU

Frailty Screening Associated With Reduced Mortality After Elective Surgery One-year mortality after elective surgery decreased significantly across nine surgical service lines after staff began screening patients for frailty using a validated tool, researchers reported.

In July 2016, surgeons at the University of Pennsylvania implemented the Risk Analysis Index (RAI), a 14-item instrument used to measure surgical frailty, as part of the standard assessment for all new patients and preoperative visits. Within six months, clinics achieved 84% compliance with recommended screening.

A year and a half into the program, staff added the RAI as an Epic Best Practice Advisory (BPA) that required providers to act on RAI scores greater than or equal to 42.

Investigators examined one-year mortality among 28,876 patients who presented for elective surgery between 2013 and 2019 and were available for analysis.

One-year mortality rates remained stable at 9.9% in the months leading up to the RAI implementation. After the assessment tool was added in the summer of 2016, absolute one-year mortality fell by 0.2% per month. This negative trend increased to 0.87% after the BPA intervention, resulting in a one-year mortality rate of 8.7% once the RAI was fully integrated into the system.

Presenting author Patrick R. Varley, MD, an assistant professor in surgical oncology at the School of Medicine and Public Health at the University of Wisconsin–Madison, said it’s unclear why the initiative affected mortality rates so significantly. It could be that providers selected patients more carefully for surgery and diverted high-risk patients

to nonoperative therapies, or providers might have engaged in more prehabilitation measures to improve patient fitness for surgery, he said.

“But because people knew there was a focus on frailty and frailty screening, they engaged in practices which improved outcomes for patients,” Dr. Varley said. “This makes it difficult to pinpoint one element of the initiative that had the most effect.”

In this study, 48% of patients underwent surgery prior to the RAI, 32% after RAI implementation but before the BPA, and 18% after the RAI was integrated into the BPA.

Presurgical Optimization Programs Benefit Patients and Surgeons: 2 New Studies Preoperative optimization programs (POPs) can improve patients’ readiness for surgery, reduce day-of-surgery cancellations, and produce financial benefits for surgical practices, new research suggests.

In a study from the University of Michigan, high-risk patients who attended a low-cost preoperative optimization clinic in the months before their elective abdominal hernia repair were successfully optimized for surgery and experienced a low rate of unintended health consequences in the lead-up to their operation.

The program also had financial benefits for the clinic, with more patients able to undergo surgery and an increase in hernia-related relative value units (RVUs) for the institution.

In 2018, the University of Michigan launched an optimization program for patients undergoing elective hernia repair. Patients who requested an elective hernia repair and had a BMI over 40 kg/ m2, were smokers, or were older than 75 years of age were directed to the onceweekly, half-day clinic led by an advanced practice provider. In appointments, the provider counseled patients about smoking cessation and nutrition, made referrals to bariatric surgery or weight programs, did weight loss check-ins, and coordinated with other health care providers to improve patients’ comorbidities.

Patients could become eligible for surgery if they successfully mitigated controllable risk factors.

Of 176 patients referred to the clinic, 52% were for weight, 34% for tobacco use and 14% for age. Median follow-up was 183 days (range, 39-378 days).

Overall, 10% of referred patients were successfully optimized for surgery. Tobacco cessation was achieved in 12% of active smokers, and 9% of people with obesity elected to pursue bariatric surgery.

The rate of hernia incarceration requiring emergent surgery was 3%.

In its first year, the program increased the rate of referred patients who underwent surgery, leading to a 19% increase in surgical yield, compared with the number of new hernia patients who were immediately eligible for surgery in 2018. Surgeons saw 10% more patients in the surgical clinic, and there was a 27% increase in hernia-attributed RVUs without altering surgeon workflow.

“These results showed a low rate of adverse health events during the time period of surgical delay, suggesting we can safely delay surgery in order to mitigate risk factors for high-risk surgical patients,” said Lia D. Delaney, BS, a medical student and researcher at the University of Michigan Medical School, in Ann Arbor, who presented the findings. “There is no detriment to the institution because we are increasing patient capacity and financial gain.”

Financial concerns, along with fears of emergent presentation, are often cited as barriers to optimization, she said. However, the University of Michigan model is low-cost, scalable and sustainable for other practices.

“Implementation of a similar model only requires a workflow adjustment for the institution, based on triaging patients who request elective surgery,” she said.

In a study from Stamford Hospital in Connecticut, patients who participated in a POP before their elective surgery were less likely to have their operation canceled on the day of their procedure.

Researchers conducted a retrospective data review of all elective surgical procedures with planned same-day inpatient admission at Stamford Hospital between October 2018 and January 2020. Of 5,352 patents scheduled for surgery over this period, 2,934 attended the hospital’s POP. Among patients who attended the POP, only 0.55% of cases were canceled on the day of surgery—far lower than the 12.4% reported in the group who were

not POP participants.

There were 300 patients of 2,418 in the non-POP group who had same-day cancellations.

All were due to incomplete workups.

In comparison, 16 of 2,934 patients in the POP group experienced same-day cancellations. Acute changes in status or noncompliance with preoperative instructions were the most significant drivers of cancellations in the POP group.

“Formalized perioperative optimization programs can significantly decrease day-of-surgery cancellation rates, can also decrease hospital costs, and, above all, provide a streamlined perioperative experience for our patients,” said presenting author Nicolle Burgwardt, MD, a surgical resident at Stamford Hospital.

Participation in the POP clinic increased over time as surgeons became more supportive of the program, she said.

Nearly 70% of surgical patients are now seen at the clinic, up from 39% in 2018.

Patient Perspectives on Surgical Cost-of-Care Conversations Surgical patients prefer a face-to-face discussion about the cost of care before their surgery, but some do not want to have these conversations with their surgeons, according to a small study.

Seventeen patients with head and neck cancer, a population uniquely vulnerable to experiencing financial toxicity related to cancer treatment, completed a survey and semi-structured interviews with researchers over a period of five to 14 months after their surgery. They also answered questions about financial

IN THE NEWS

DECEMBER 2020 / GENERAL SURGERY NEWS

Volume Ratio Alone Not a Good Predictor of Fascial Closure for Ventral Hernias

By KAREN BLUM

distress related to cancer care using the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy tool.

All participants were patients at the Vanderbilt Bill Wilkerson Center, in Nashville, Tenn. They had an average age of 62.9 years (range, 41-90 years), 65% were of male gender, and 88% were white. Forty-seven percent of the patients had an income of less than $50,000 per year. Overall, seven patients had private insurance, seven had Medicare insurance, and three had Medicaid or were uninsured.

The results showed that patients enrolled in Medicaid or who were uninsured experienced the greatest financial toxicity. More than other patients, they wanted financial information earlier in their treatment course, including a breakdown of full surgical costs. “The conversation needs to be had in case somebody needs to save, borrow,” one participant said.

Across all groups, patients preferred discussing costs before treatment, noting that it was inappropriate to avoid discussion of finances. They had mixed opinions about surgeons raising the topic; most preferred to discuss finances with insurance representatives and hospitalemployed financial advisors.

In these conversations, patients value transparency, empathy, and the separation of costs and care most highly, said Thomas Day, a medical student at Vanderbilt University School of Medicine, and a study author.

“We can see that there’s no formula for success for discussing finances. Rather, patients value the empathetic delivery of information more than specific times, personnel or types of information to disclose.”

Surgeons and other health care providers should consider patients’ insurance status and financial burden during these conversations, as they may influence preferences, he said.

“If possible, an ideal approach to cost-of-care conversations may be letting patients know that you are aware that cost can be a significant concern for many people and that you can refer them to a financial counselor for more assistance.”

The American College of Physicians and the National Patient Advocate Foundation have published guides to help physicians with cost-of-care conversations. ■

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method of using the hernia sac to abdominal cavity volume ratio to predict fascial closure for large ventral hernia operations may only be accurate when that ratio is below 25%, according to new research.

Cleveland Clinic surgeons validated a previously published method calculating the volume ratio using cross-sectional imaging (Hernia 2010;14[1]:63-69) by applying it to data from a sample of patients from their own institution. The original study proposed that patients with volume ratios of 25% or higher would benefit from preoperative progressive pneumoperitoneum, as surgeons would be unlikely otherwise to achieve complete fascial closure.

The Cleveland Clinic group found the technique to be helpful in predicting complete fascial closure, but only when that ratio was below 25%. It was less accurate for ratios of 25% or higher, suggesting that other factors contribute to the ability to achieve complete fascial closure, the authors said. Results were presented at the 2020 annual meeting of the Americas Hernia Society, held virtually this year.

“Surgical management of complex ventral hernias remains challenging for the reconstructive surgeon,” said Aldo Fafaj, MD, a surgery resident and lead author of the study. “Despite advancements in abdominal wall reconstructive techniques, complete closure of the anterior fascia is not always achieved. This requires bridging of the mesh, which has been associated with increased morbidity and recurrence rates.”

To test the published method, Dr. Fafaj and his colleagues pulled data from 437 Cleveland Clinic patients who underwent elective open repair of incisional hernias that measured 18 cm or larger between December 2014 and November 2019, and reviewed CT images. Researchers measured volume ratio as well as the positive and negative predictive values of the 25% volume ratio cutoff.

In their sample, 336 patients had complete fascial closures and 101 had incomplete fascial closures. There were some baseline differences between the two groups, Dr. Fafaj said.

Those who had incomplete fascial closures had a lower BMI (average, 33.1 vs. 34.4 kg/m2; P=0.009); larger hernia widths (average, 25 vs. 21 cm; P<0.001); more hernia recurrences (average, 78.2% vs. 60.2%; P=0.001) since the indication for repair; and were more likely to have a history of open abdomen procedures (average, 28.7% vs. 11%; P<0.001) than those who had complete fascial closures.

The median volume ratio was 11% in the complete fascial closure group and 35% for the incomplete group. Studying operative details, researchers found that patients in the incomplete fascial closure group had longer operating times (median, five vs. four hours; P<0.001) and less use of sublay mesh (96% vs. 99%; P<0.001) compared with those in the complete group.

Among patients, 146 had a volume ratio greater than or equal to 25%. Therefore, researchers found the volume ratio cutoff of 25% had a sensitivity of 77%, a specificity of 64%, positive predictive value of 88% and negative predictive value of 45%.

“The proposed volume ratio cutoff can reliably predict complete fascial closure below 25%,” Dr. Fafaj said. “Although

there is a higher likelihood of incomplete fascial closure when the volume ratio is greater than or equal to 25%, this outcome cannot be reliably predicted because in over half of our cases, we were able to achieve complete fascial closure. This means there are additional factors that play a role in achieving complete fascial closure during abdominal wall construction.”

Some studies have highlighted the use of preoperative pneumoperitoneum, botulin toxin or a combination of both

‘Although there is a higher likelihood of incomplete fascial closure when the volume ratio is greater than or equal to 25%, this outcome cannot be reliably predicted because in over half of our cases, we were able to achieve complete fascial closure.’

—Aldo Fafaj, MD

for complex ventral hernias, Dr. Fafaj said, but a randomized controlled trial may be necessary to identify the true value of the volume ratio cutoff for such programs.

The researchers added “a new little piece to the puzzle” regarding what information surgeons can glean from gathering presurgical images, commented Eric M. Pauli, MD, a professor of surgery at Penn State Health Milton S. Hershey Medical Center, in Hershey, Pa. The paper’s strengths are that it came from a large group that performs open hernia repairs commonly and consistently, said Dr. Pauli, a board member of General Surgery News.

“The information from this study is usable to help you predict if you can get the abdominal wall closed,” he said. “Those predictions can help and influence the discussions that you have with patients ahead of [surgery].”

The downside, Dr. Pauli noted, is the study was completed by expert hernia surgeons at a large center, so the results may not be applicable to lower-volume centers. “It doesn’t mean the information isn’t translatable,” he said. “It just means that this could be a tool that surgeons use to have a discussion with the ■ patient about what they are going to do in the OR.” Wound Care Survey Contest Winner Congratulations to Dr. Kathryn Eckert who has won the $500 wound care survey drawing prize (from the October issue). Dr. Eckert is a general surgeon in Haddon Heights, NJ. Her name was selected at random from the more than 450 surveys we received.

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IN THE NEWS

GENERAL SURGERY NEWS / DECEMBER 2020

Opioids Can Be Avoided After Most Lumpectomies, Breast Biopsies

By KATE O’ROURKE

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ew data show that in patients with breast cancer undergoing a lumpectomy or excisional biopsy, nonsteroidal anti-inflammatory drugs and opioids deliver comparable pain control.

“Routine discharge with opioids is unnecessary in patients undergoing lumpectomy/excisional biopsy procedures,” said Tracy-Ann Moo, MD, an assistant attending at Memorial Sloan Kettering Cancer Center (MSKCC), in New York City, presenting at the 2020 annual meeting of the Society of Surgical Oncology.

Dr. Moo noted that in 2017, there were 47,600 deaths from drug overdose in the United States, with approximately 17,000 attributed to prescription opioids.

“A number of studies demonstrate that opioids are overprescribed in the postoperative setting and that unused tablets become available for diversion and misuse in the community,” Dr. Moo said.

While lumpectomy and excisional biopsy are commonly performed ambulatory breast procedures that are not associated with a significant amount of pain after discharge, a survey of over 600 members of the American Society of Breast Surgeons showed that approximately 80% of surgeons routinely prescribe opioids after lumpectomy (Ann Surg Oncol

2020;27[4]:985-990).

In August 2018, as part of a quality improvement initiative, MSKCC started eliminating routinely prescribed opioids in patients undergoing lumpectomy or excisional biopsy. Instead, they sent patients home with a prescription for the NSAID diclofenac, unless NSAIDs were contraindicated in a patient.

The new study retrospectively evaluated the opioid prescription rate after change from routine discharge with opioids to diclofenac and determined the NSAID failure rate by assessing the number of patients who were discharged with NSAIDs who were prescribed opioids for pain control within seven days of the procedure. The study also compared patient-reported post-discharge pain scores in the time period where opioids or diclofenac were routinely prescribed.

At MSKCC, all ambulatory breast surgery patients are treated with intraoperative ketorolac, IV acetaminophen, and an injection of both short- and long-acting local anesthetic at the surgical site. All opioid prescriptions are placed electronically, allowing doctors to query the electronic medical record to document opioid prescriptions at or within seven days of discharge. Patient-reported post-discharge pain scores are documented in the Recovery Tracker, a post-discharge survey

‘Compared to the study period where we routinely prescribed opioids, there was no difference in the proportion of patients reporting moderate or severe pain when we switched to routine NSAIDs.’ —Tracy-Ann Moo, MD completed via the MSKCC patient portal on postoperative days 1 through 5, using a scale of 0 to 10 with 0 being no pain, 1 to 3 being mild pain, 4 to 6 being moderate pain, 7 to 8 being severe pain, and 9 to 10 being very severe pain.

The researchers examined lumpectomy or excisional biopsy patients from December 2017 to August 2018 (n=328), when routine opioids were prescribed, and from August 2018 to June 2019, when routine NSAIDs were given (n=461). Among the two study periods, there was no difference in age, BMI, American Society of Anesthesiologists physical status, or race. In addition, there was no difference between the two groups in terms of intraoperative characteristics, except more patients who were prescribed NSAIDs received more acetaminophen (97% vs. 94%). A greater proportion of patients treated in the opioid period received greater than 10 morphine milligram equivalents (10.3% vs.

5.6%). Whereas 96% of patients received opioids in the routine opioid period, only 14% received opioids in the routine NSAID period. The NSAID failure rate was 1%.

“Compared to the study period where we routinely prescribed opioids, there was no difference in the proportion of patients reporting moderate or severe pain when we switched to routine NSAIDs,” Dr. Moo said. Further, there was a nonsignificant trend toward more frequent reports of moderate/severe pain among patients discharged with an opioid prescription versus an NSAID over both time periods.

According to Shelley Hwang, MD, the vice chair of research and chief of breast surgical oncology at Duke University, in Durham, N.C., the new study is practice-changing and demonstrates that opioids can be avoided in most cases of lumpectomy or excisional biopsy.

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What Is Value of Therapeutic Lymph Node Dissection in Melanoma?

By KATE O’ROURKE

D

ata from a new study indicate a lack of therapeutic benefit for therapeutic lymph node dissection for patients with lymph node recurrences in melanoma.

The study was presented at the 2020 annual meeting of the Society of Surgical Oncology (abstract 79).

According to Ana Wilson, MS, DO, a second-year fellow at John Wayne Cancer Institute, in Santa Monica, Calif., who presented the data, approximately 10% to 15% of patients with melanoma who had negative sentinel lymph node biopsies at their index operation will experience a locoregional recurrence, and 4% to 10% of patients will develop an isolated lymph node recurrence in the same basin, depending partly on the experience of the surgeon.

“The majority of these recurrences happen in the first two years after surgery and are more common in patients with thicker, ulcerated primary lesions; lesions on the trunk, head or neck; and in patients who are male,” Dr. Wilson said.

Although completion lymphadenectomy is no longer recommended for patients with melanoma and tumorpositive sentinel lymph nodes, therapeutic lymph node dissection is still recommended for patients with melanoma and lymph node recurrences, Dr. Wilson said.

The new study investigated the potential survival benefit of therapeutic lymph node dissection in patients with nodal recurrence after a previously negative sentinel

lymph node dissection.

The researchers used the John Wayne Cancer Institute’s melanoma database of over 15,000 patients and data from the MSLT-1 (Multicenter Selective Lymphadenectomy Trial), to identify patients with nodal recurrences after a negative sentinel lymph node biopsy. Patients with concomitant local or distant recurrence were excludded. The investigators compared patients who underwent therapeutic lymph node dissection with those who underwent biopsy alone, focusing on differences in clinicopathologic characteristics, distant metastasis–free survival and melanoma-specific survival between the groups.

The investigators identified 172 patients with lymph node recurrence in a previously negative sentinel lymph node basin during the study period (1991-2017). Median follow-up was 30 months from the time of recurrence.

Therapeutic lymph node dissection was performed in 78% of patients, and 22% were treated with lymph node biopsy alone. Five-year distant metastasis–free survival was 50.4% for patients who had a biopsy alone compared with only 39.4% for those having therapeutic lymph node dissection (P=0.13). Overall, five-year melanoma-specific survival was 59.4% in the biopsy group and 45.9% in the therapeutic lymph node dissection group (P=0.10). In the therapeutic lymph node dissection group, 40.3% had one tumor-positive lymph node and 59.7% had two or more. For both subgroups, melanoma-specific survival was lower than the biopsy-alone group (52.8% and 41.2%, respectively; P=0.07). There

was no significant difference in use of systemic treatment or immunotherapy between the groups.

“Therapeutic lymph node dissection did not improve survival in this retrospective study of patients with nodal recurrence of melanoma,” Dr. Wilson said, noting that there was a trend toward worse outcomes after therapeutic lymph node dissection. “Although the survival appears better in the biopsy-only group, the cohort is too small and varied for this to be statistically significant,” she said.

According to Dr. Wilson, presumably, at least some patients in the biopsy-alone group had multiple involved lymph nodes, yet they still had at least equivalent outcomes to patients with one positive node treated with therapeutic lymph node dissection.

“At face value, these were somewhat unexpected findings,” said Sandra Wong, MD, a melanoma expert and the William N. and Bessie Allyn Professor of Surgery and chair of the Department of Surgery at DartmouthHitchcock in Lebanon, N.H., and the Geisel School of Medicine at Dartmouth, in Hanover, N.H. “But, one important consideration is that there is no therapeutic benefit to removing negative nodes. If the patients in the biopsy-alone group had all disease cleared with that biopsy, then there was 1) a relatively low burden of disease (likely one involved node) and 2) likely enough therapeutic benefit from the biopsy alone to explain some of the distant metastasis–free survival and melanoma-specific survival results that were presented,” Dr. Wong said.

■

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Important Safety Information Kcentra is a blood coagulation factor replacement indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra is for intravenous use only.

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events.

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8

IN THE NEWS

GENERAL SURGERY NEWS / DECEMBER 2020

Resident Unions continued from page 1

virtual 2020 ACS Clinical Congress.

Pro: Unions advocate for residents and ensure employer accountability.

Why would residents want to form a union today? In 1999, when the American Medical Association (AMA) House of Delegates voted to form a union, Physicians for Responsible Negotiation, it was largely to protect physicians from unreasonable demands. In the case of

residents, these could be requests for unreasonable working hours or conditions, said Susan Adelman, MD, a former professor of surgery at the University of Michigan in Ann Arbor.

“Now the reasons might be related to electronic health records [EHRs], fallout from hospital mergers, lack of protection for resident physicians who are pregnant, and issues of patient safety,” she said.

The Accreditation Council for Graduate Medical Education (ACGME)

Pro Argument: ‘While medicine is a calling for physicians, it’s a business for the hospital. Hospitals readily take advantage of resident salary price fixing, and residents are often scheduled to cover the longest and most undesirable shifts, not for educational purposes but because it serves the bottom line of the hospital.’

—Brooke Bredbeck, MD requires all residency programs to maintain a house staff association to advocate for residents, but some trainees believe those groups are not adequately positioned to effect change, Dr. Coleman said.

In addition to the house staff requirement, the ACGME has a number of

Important Safety Information (continued) Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin).

Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).

Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment.

In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

Kcentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

KCENTRA® (Prothrombin Complex Concentrate [Human]) For Intravenous Use, Lyophilized Powder for Reconstitution Initial U.S. Approval: 2013

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BRIEF SUMMARY OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Kcentra safely and effectively. See full prescribing information for Kcentra.

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding.

• Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Kcentra in clinical trials and post marketing surveillance. Monitor patients receiving Kcentra for signs and symptoms of thromboembolic events.

• Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months.

------------------------------------INDICATIONS AND USAGE---------------------------------Kcentra, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: • acute major bleeding or • need for an urgent surgery/invasive procedure.

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other requirements of residency programs designed to protect residents; programs that fall short of meeting these requirements risk loss of accreditation. That may be a powerful motive for a program to follow ACGME guidelines, but it’s not clear how an actual loss of accreditation would benefit residents, Dr. Adelman noted.

“This would not be what residents want.”

She acknowledged that unionizing can create an “us versus them” relationship with administration, which is why it should be used as a last resort, “when you’ve tried to solve a problem in a collegial way and failed.”

A commonly held perception of unions is that striking is their most powerful tool; to many, the idea of a physician strike seems antithetical to the profession. Sriram Rangarajan, MD, MAS, a general surgery resident at Arrowhead Regional Medical Center and Kaiser Permanente in Colton, Calif., observed, “The morality and ethicality of a resident physician strike is unclear.”

But unions can use less disruptive tactics to get their point across, Dr. Adelman said.

“Consider the power of the press. If you call a reporter or post on social media and explain that the objectives of the union are good for the hospital, for patients and for the community; if you argue that the hospital’s resistance is harming the community or patient care, that’s powerful leverage.”

Brooke Bredbeck, MD, a surgical resident at the University of Michigan in Ann Arbor, acknowledged that opinions on unionization are highly charged: heroic defense of workers’ rights versus bureaucratic obstructionism. In medicine, where the stakes are high and labor practices are restricted, unions should be used only under one of two conditions, she said: “first, if employees are exposed to unsafe working conditions, and second, if employees cannot engage in a competitive market and are therefore at high risk for exploitation.”

The implementation of duty-hour restrictions aside, medical residency has changed little over the past decades, and a substantial factor limiting reform is financial, Dr. Bredbeck said.

“While medicine is a calling for physicians, it’s a business for the hospital.

Hospitals readily take advantage of resident salary price fixing, and residents are often scheduled to cover the longest and most undesirable shifts, not for educational purposes but because it serves the bottom line of the hospital.”

A union can serve as a powerful

IN THE NEWS

DECEMBER 2020 / GENERAL SURGERY NEWS

advocate when dynamics are unbalanced, she said—for example, to collectively bargain for fair wages and working conditions. At her institution, the union also advocates for benefits, such as paid parental leave for non-birthing parents.

“If a dispute occurs and cannot be resolved within the program, which is, of course, the preferred method of resolution, the union has administrative and legal authority to pursue resolution.”

Con: Unions foster an adversarial culture and can jeopardize resident training.

to protect laborers, and residents are not laborers. Despite the National Labor Relations Board’s 1999 decision to consider residents primarily as employees, their duties and responsibilities align more closely with those of students, he said.

“Residents are apprentices who are expected to combine on-the-job acquisition with daily study and repetition.”

The amount of time residents have to accomplish these goals is finite and regulated by the ACGME, and residents already struggle to balance academic endeavors with family responsibilities and other life matters, Dr. Rangarajan

said. He observed that some potential union demands, like shorter work shifts, more days off and limited call could further chip away at their time in training.

“Residency is a fleeting, precious time; the closer it comes to an end, the more apparent this becomes,” Dr. Rangarajan said.

Furthermore, “unionizing as surgical residents has the potential to complicate the relationship with faculty and undermine the public’s trust in resident surgeons.”

Wrapping up the debate, Dr. Coleman reiterated physician unionization’s

As John Potts III, MD, a senior vice president of Surgical Accreditation at the ACGME, sees it, considering that only a slim minority of physicians in the United States belong to a union, perhaps only a few thousand out of nearly a million similar organizations are unwanted.

“Potential members are staying away in droves,” Dr. Potts said. “It’s also difficult for me to believe that patients want their physicians to be union members.”

Physician unions are also unnecessary, he said, observing that the ACGME protects many of the same standards as a union would.

“If one goes through the due process of one’s own institution and is not satisfied with the outcome, one can always file a complaint directly with the ACGME,” Dr. Potts said.

tumultuous history. Those who support unionization see it as a way that residents can advocate for issues ranging from medical debt to patient care without eroding professional relationships, while those who oppose unionization argue that it undermines professionalism and detracts from clinical and educational duties.

“Ultimately, while the solution to this debate could be specific to each institution or region, there must inevitably be an effective mechanism for residents to voice their concerns, be heard and understood, and most importantly be respect■ ed,” Dr. Coleman said.

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Con Argument: ‘The “hammer” of any union is a work stoppage.

Any work stoppage in the care of patients betrays not only those patients but also the profession.’

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—John Potts III, MD Unions are also not necessary as tools for advocacy at the state and national level, Dr. Potts said. “The ACS, the AMA and many other membership organizations actively advocate not only on behalf of practicing physicians but also on behalf of residents.”

The most important argument against resident unions, he said, is that they are unprofessional. “The ‘hammer’ of any union is a work stoppage. Any work stoppage in the care of patients betrays not only those patients but also the profession.”

Although he agrees with Dr. Adelman that there are several issues for which residents may wish to advocate, “patient safety, the burdens of EHR, fallout from the seemingly never-ending hospital mergers,” they should not strike.

“They should advocate through their local resident forums, through the RAS and ACS, and even through social media.”

At a fundamental level, Dr. Rangarajan argued that resident unions are inappropriate because unions were designed

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CLINICAL REVIEW

GENERAL SURGERY NEWS / DECEMBER 2020

The Way of the Wound Overview of Wound Care for Surgeons

By MASOOD SHARIFF, MD, and PETER KYUNGHWAN KIM, MD

A

ll surgeons and many other physicians create and treat wounds. General surgeons were once the masters of the care of both physical and, sometimes, emotional wounds. Wound care requires an understanding of normal wound healing, causes of delays of wound healing, and the management of wounds. Every wound must be treated in regard to cause, chronicity, location and level of microbial contamination, as well as critical patient factors that greatly affect wound healing, such as age, immunosuppression, nutrition, off-loading and eradication of infection.

Too many patients of the underserved populations in the Bronx, N.Y., where we practice, are struck with the worst disease—not COVID-19 or HIV, but uncontrolled diabetes. For them and others, wound care is a common necessity that requires increasing health care attention. If appropriate care is not given early, expensive complications to the woundhealing process can lead to multiple ER visits, the development of chronic nonhealing wounds, and even amputation.

Knowledge of wound care products, negative pressure wound therapy and drain placement to manage dead space can improve outcomes with wound healing. Inappropriate product use can cause delays in healing. As wound healing progresses, management of a wound and the bandage materials must be open to innovation.

Evolution of the Standard of Care in Wound Management The “standard of care” in wound management is evolving and used to include a wet-to-dry gauze dressing that is performed daily until wound closure occurs, with an average time of one to 10 weeks.

New biological products that provide an added layer of reinforcement and coverage on open wounds with tissue regenerative properties have been shown to increase wound healing and hasten recovery in the clinical care setting. The era of regenerative medicine has begun, but excellent, well-designed studies are lacking.

Wound care requires the achievement of an optimal environment for epidermal renewal with preservation of underlying skin and deeper tissues, with constant care and monitoring of secondary complications, such as infection or dehiscence. This process is a prolonged feat

that the health care team undertakes to ensure proper healing, and it may necessitate expensive personnel and devices in the outpatient setting. The wound bed needs to be well vascularized, free of devitalized tissue, clear of infection and moist. Wound dressings should eliminate dead space, control exudate, prevent bacterial overgrowth, ensure proper fluid balance, be cost-efficient, and be manageable for the patient and any health care staff. Wounds that demonstrate progressive healing as evidenced by granulation tissue and epithelialization can undergo closure or coverage.1,2 Many topical agents and alternative therapies are available that are meant to improve the wound-healing environment. Although definitive data are lacking to support any recommendations, some may be useful under specific circumstances.3,4 Moist wound healing is the standard of care. The area in and surrounding an abscess is usually acidic in pH; thanks to the Henderson-Hasselbalch equation, antibiotics—and even local anesthetics—are inactivated due to their pKa, or acid dissociation constant.

Therefore, teaching point No. 1 is this: When abscesses need to be drained and cultured, call a surgeon. Don’t forget to culture the infected fluid because of the possibility of drug-resistant organisms.

Necrotic tissue is food for bacteria that can replicate as fast as every 20 minutes in the setting of an all-you-can-eat buffet. Therefore, when dead tissue needs to be debrided, call a surgeon.

The Importance of Debridement Before wound healing, the area needs to be free of any foreign or dead tissue.

Necrotic tissue is food for bacteria that can replicate as fast as every 20 minutes in the setting of an all-you-caneat buffet. Therefore, when dead tissue needs to be debrided, call a surgeon. We need to sharply debride necrotic debris and hypergranulation tissue, typically in an OR, to create a wound bed that is a healthy pink-red in color. Tissue that bleeds is usually alive, and the scalpel is a handy tool that is both diagnostic and therapeutic. Vascular diseases, diabetes, pressors and sepsis can result in poor

Treating a diabetic foot ulcer. blood flow to the tissues that require revascularization and critical care. Source control is paramount, and serial excisional debridements of necrotizing skin and soft tissue infections should be the rule, not the exception.

At the end of a major debridement of necrotizing tissue, I ask myself and the residents three questions: 1. “Did we come to the OR for the right reason, that is, was the surgery indicated?”

2. “Did we do enough?” Hopefully, yes, but sometimes it is appropriate to schedule another good look in the OR 24 to 48 hours later where, resources willing, the wound can be evaluated and treated. This is a good time to get the reconstructive plastic surgeons involved for future wound coverage.

3. My final question is, “Did we do too much?” Most patients do not want their feet—much less any toes—cut off unnecessarily, but source control for sepsis often demands these extreme measures. Limb salvage is a complex process that may require multidisciplinary care, but life over limb should prevail, including quality of life, salvaging a lower extremity that cannot be used for ambulation. Sometimes early amputation is the wise choice for the clinicians and the patient.

Diabetic Foot Ulcers On a less dramatic but more insidious note, one of the major clinical diagnostic billing codes that arises for wound care is maintenance of a diabetic foot ulcer.5 These ulcers are a major cause of morbidity and mortality, accounting for approximately two-thirds of all nontraumatic amputations performed in the United States.6,7 In these patients, chronic hyperglycemic episodes lead to neuropathy and vasculopathy causing the skin to break down and progress to an ulcerative or gangrenous process, resulting in an open wound. The wound is

Source: Adobe Stock

evaluated for vitality with sharp debridement or even amputation.

Infected or ischemic diabetic foot ulcers account for approximately 25% of all hospital stays for patients with diabetes. The healing time for a diabetic foot ulcer ranges from two to 15 weeks, with an average of eight weeks.8 Appropriate local wound care can achieve 50% surface area reduction or reduction of ulcer depth in four weeks.9 If this rate of progress is not observed, further management to address glycemic control, edema, and other aspects of general health and nutrition should be considered. Ulcers that still do not improve should be reevaluated for ongoing soft tissue infection or osteomyelitis, impaired extremity vascular flow, and, most commonly, the need for more effective off-loading or surgical debridement.10

Venous Stasis Another clinical pathology that leads to lower extremity wounds is venous stasis. The proportion of the population suffering from obesity and chronic venous insufficiency is increasing, and obese patients are more likely to be symptomatic because of their venous disease.11 The final common pathway that leads to chronic venous insufficiency is the development of venous hypertension. In most cases, venous hypertension results from obstruction of venous flow, dysfunction of venous valves, and/or the venous flow is directed abnormally from the deep to the superficial system, producing local tissue inflammation, fibrosis and occasional ulceration. Sustained venous hypertension is associated with histologic and ultrastructural changes that lead to increased vascular permeability (edema) and the chronic release of inflammatory mediators that are the fundamental cause of cutaneous hyperpigmentation, trophic skin changes and ulceration.12 New techniques using radiofrequency ablation by vein specialists for patients with venous

CLINICAL REVIEW

DECEMBER 2020 / GENERAL SURGERY NEWS

reflux disease have been promising for those formerly relegated to compression with weekly Unnaâ&#x20AC;&#x2122;s boot changings and Jobst stockings.

The Ideal Dressing The standard of care for wound healing has been wet-to-moist gauze dressings that are useful for packing large soft tissue defects until wound closure or coverage with split-thickness skin grafts can be performed. In the literature, average wound closure with wet-to-moist gauze dressings has been approximately 5.7Âą4.6 weeks.13-17 Acute wound fluid is rich in platelet-derived growth factor, basic fibroblast growth factor, and has a balance of metalloproteases serving as a matrix custodial function. These interact with one another and other cytokines to stimulate healing. An ideal dressing is one that absorbs excessive wound fluid while maintaining a moist environment that protects the wound from further mechanical or caustic damage.

Also, the ideal wound dressing conforms to the wound shape, eliminates dead space, achieves hemostasis and minimizes edema through compression. New hydrogels and alginates pervade the toolbox for nurses and physicians who specialize in wound care.

Negative Pressure Wound Therapy and Hyperbaric Oxygen Therapy Larger wounds, due to various pathophysiologic conditions, could become edematous and benefit from negative pressure wound therapy or hyperbaric oxygen chamber therapy, particularly for radiated tissue and chronic, nonhealing wounds. Negative pressure wound therapy accelerates wound healing where the subatmospheric pressure improves and accelerates healing by reducing the time to wound closure.18-21 As any therapy, negative pressure wound therapy and hyperbaric oxygen chamber therapy are not always effective, have a cost associated with them, and will require the wound care team to reevaluate other possibilities.

Several studies include a standard-ofcare arm measuring wound size, duration of wound, healing time in days to complete epithelization, patient characteristics, and many complications and adverse events.22-35 In a literature review, the healing time for standard-of-care wet-to-moist dressing changes was an average of 53.3Âą24.5 days, which is a difference of 18 days compared with negative pressure wound therapy (35.1Âą17.2 days).22-35

structure, usually derived from a biological source (xenoform or alloform), and is implanted on the open exposed wound.

Tissue engineering has produced these biological products that have shown at the microscopic level to adhere, blend and act as a supporting matrix in the patientâ&#x20AC;&#x2122;s body to reepithelialize denuded areas and enhance tissue recovery and the healing process. The biological tissue is taken and put under multiple sterilization steps and is decellularized to maintain and retain the native extracellular matrix, which has been shown to adapt with the bodyâ&#x20AC;&#x2122;s own connective

tissue cellâ&#x20AC;&#x2122;s matrix of type I collagen, type IV collagen and fibronectin. This allows â&#x20AC;&#x153;regenerativeâ&#x20AC;? remodeling of the wound instead of engaging in a process that leads to scar tissue formation.36,37 The structure allows for support, growth and proliferation of epithelial cells. This type of matrix has been derived from small intestinal submucosa and urinary bladder tissue. Uses have been numerous with repair of hernias as well as musculoskeletal, cardiovascular, urogenital and integumentary structures. We hope this review of basic ideas and concepts for practicing surgeons will spark the

imagination of a new era in wound care management. â&#x2013;

References [A full list of references for this article can be found at www.generalsurgerynews.com]. â&#x20AC;&#x201D;Dr. Shariff is a research fellow in New York City. Dr. Kim is a general surgeon in the Bronx, N.Y., a member of the General Surgery News editorial advisory board, and co-editor of the GSN wound care section.

The authors reported that they have no relevant relationships.

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GENERAL SURGERY NEWS / DECEMBER 2020

Avoiding Bile Duct Injury During Lap Chole: What Is the Best Approach? o far, 2020 has been a difficult year for everyone. We just went through an election during an overwhelming pandemic and hospitals, once again, are filling up with COVID-19 patients. Hopefully, with conservative measures like mask wearing and social distancing, along with vaccines that are on the horizon, we will be back to some sort of normalcy in our surgical practices in 2021. We had planned the important debate we present today almost a year ago, but were unable to bring it to you until now because the debaters have been so overwhelmed by the pandemic.

Our society meetings have all gone virtual and elective surgical practices have been on hold. Despite the changes in practice patterns due to the decrease in elective surgery, the treatment of biliary disease remains one of the most common problems that general surgeons face. Reducing common duct injuries may even be a more important issue during this pandemic. As you know, common duct injury prevention remains controversial and is one of the most highly debated topics at our national meetings. Despite multiple attempts to reduce the incidence of common duct injury following laparoscopic cholecystectomy (LC), the incidence has remained fairly constant

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even with most surgeons being beyond the learning curve. We should be asking ourselves three questions: 1) is this a surgeon problem?

2) is this due to technique? and 3) is there some procedure that can eliminate most common duct injuries or reduce the incidence?

We have brought together three experts in biliary surgery who have three very different opinions. It is up to you to carefully evaluate their arguments and decide which method is best for your practice. There is no question that we all want to avoid this complication. Can it be done, and how, are the questions that we must answer. I am hopeful this monthâ&#x20AC;&#x2122;s debate will make all of us evaluate how we approach the patient needing an elective or emergent cholecystectomy, and in the future, we can significantly reduce the incidence of common duct injury. If you have questions or opinions, please send them to us at khorty@mcmahonmed.com so we can continue the discussion until we have an answer to this problem.

Edward L. Felix, MD Editor, The Great Debates es General Surgeon, Pismo Beach, Calif. f.

The Case for Routine Use of Intraoperative Cholangiography During Cholecystectomy

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he debate over routine versus selecoperation, and a history of gallstone pancretive intraoperative cholangiography atitis). One could also strongly argue that it (IOC) during LC goes back almost to the should be done routinely in patients who have origins of the procedure itself. One should had a gastric bypass because of the altered first consider that today most surgeons anatomy that may preclude postoperative practice selective cholangiography, which ERCP. Since biliary anatomy has many means that many use it infrequently. There variations, frequent use of IOC enhances are several reasons why IOC should be recognition of aberrant anatomy (e.g., aberL. Michael used at least liberally in clinical practice: rant right posterior hepatic duct) as well as Brunt, MD 1) it is an important and unique skill comCBD stones. It can also lead to recognition Section of Minimally ponent of cholecystectomy and surgeons that the CBD has been mistakenly dissectneed to be facile with the technique so ed, thus avoiding a higher level of injury.

Invasive Surgery it can be reliably performed; 2) it enables With the advent of LC, surgeons have Washington University accurate interpretation of cholangiogram largely abandoned management of CBD School of Medicine findings; 3) it may help identify aberrant stones. However, several studies have shown St. Louis, MO biliary anatomy; 4) it is essential for identhat one-stage management of CBD stones tification of common bile duct (CBD) stones intraop- at the time of LC is more cost-effective and may result eratively and a prerequisite for performing laparoscopic in fewer adverse events than use of postoperative ERCP CBD exploration; and 5) it may reduce both the inci- with its attendant risks for pancreatitis and other comdence of biliary injury and the severity of the injury plications.1-3 Further, many community hospitals may (i.e., avoiding excision of a segment of the CBD when not have ready access to postoperative ERCP. Facility an injury has occurred). with cystic duct cannulation and assessment for CBD The ability to perform IOC is an essential skill that stones is essential for surgeons who want to perform all surgeons who perform cholecystectomy should have laparoscopic CBD exploration. in their armamentarium. IOC requires an incision in the The role of IOC in prevention of bile duct injury was cystic duct and cannulation with a small catheter, which examined in detail by the recent consensus conference can be challenging in some patients due to cystic duct on prevention of bile duct injury during cholecystectovalves. The ability to do IOC consistently and efficient- my.4 Randomized controlled trials have been underpowly requires, at least at some point in oneâ&#x20AC;&#x2122;s practice, having ered to address this question, but large administrative done it numerous times and under varying circumstanc- database studies have, more often than not, shown an es of gallbladder pathology. The reality, however, is that association of use of IOC with a reduction in the inciselective cholangiography in most surgeonsâ&#x20AC;&#x2122; practices dence of biliary injury. In the consensus analysis of 14 means it is infrequently done. Selective cholangiogra- large studies involving more than 2.5 million patients, phy should also mean that it is routinely done in situa- the use of IOC was associated with a reduction in bile tions in which the patient is at increased risk for having a duct injury in both unadjusted (odds ratio [OR], 0.78 bile duct stone (ie, dilated CBD, abnormal liver function [95% CI, 0.63-0.96]) and risk-adjusted analyses (OR, tests preoperatively, stones found in the cystic duct at 0.81 [95% CI, 0.62-1.07]). However, many of these

studies have a moderate or high risk for bias. In the Swedish National Gallriks database study of more than 51,000 cholecystectomies, the use of or intent to use IOC was associated with a reduction in bile duct injury in acute cholecystitis only.5 The guideline panel recommended that in patients with acute cholecystitis or a history of acute cholecystitis, IOC should be used liberally to mitigate the risk for bile duct injury.4 No recommendation was made for elective cholecystectomy due to uncertainty of the evidence. For surgeons with appropriate expertise, laparoscopic ultrasound is an alternative to IOC.

The guideline panel recommended that in patients with acute cholecystitis, IOC should be used liberally to mitigate the risk for bile duct injury.

A strong recommendation from the consensus was that IOC should be used in cases with uncertainty of biliary anatomy or suspicion of biliary injury. In the consensus review of nine studies that addressed this question, IOC was significantly associated with increased intraoperative detection of bile duct injury (OR, 2.92; 95% CI, 1.55-5.68; P=0.014).

What about near-infrared cholangiography (NIRC)?

Certainly, NIRC has promise and is easy to use, but it has not been widely studied outside of selected centers, or in large numbers of patients with obesity, acute cholecystitis or other difficult gallbladder scenarios. The technology for NIRC also has not yet widely penetrated throughout hospitals worldwide. In the consensus review, current evidence was found to be insufficient to make a recommendation regarding comparison to IOC. Compared with white light, including the study

GREAT DEBATES

DECEMBER 2020 / GENERAL SURGERY NEWS

from Dr. Raul Rosenthal’s group,6 as expert opinion, we recommended that NIRC could be a useful adjunct to standard white light alone (conditional recommendation, low certainty of evidence), but should not be a substitute for good dissection and identification technique.4 It should also be noted that NIRC does not assess the bile duct for presence of stones.

So, what to conclude? In my own practice, I perform IOC routinely for all the reasons above, but I do not presume to recommend that all surgeons should take this approach. However, to perform IOC rarely or not at all, or not in a significant percentage of one’s cases, I would posit is a missed opportunity to identify unsuspected

pathology, potentially reduce biliary injury risk, provide training for residents and maintain an important skill set. To do otherwise risks fostering an entire generation of surgeons who are lacking in this fundamental component of performing safe cholecystectomy.

References 1. Berci G, Hunter J, Morgenstern L, et al. Laparoscopic cholecystectomy: first do no harm; second take care of bile duct stones. Surg Endosc. 2013:27(4):1051-1054.

2. Bansal VK, Misra MC, Rajan K, et al. Single-stage laparoscopic common bile duct exploration and cholecystectomy versus twostage endoscopic stone extraction followed by laparoscopic cholecystectomy for patients with concomitant gallbladder stones and common bile duct stones: a randomized controlled trial. Surg Endosc. 2014;28(3):75-85.

3. Schwab B, Teitelbaum EN, Barsuk JH, et al. Single-stage laparoscopic management of choledocholithiasis: an analysis after implementation of a master learning resident curriculum. Surgery.

2018;163(3):503-508.

4. Brunt LM, Deziel DJ, Telem DA, et al. Notice of duplicate publication [duplicate publication of Brunt LM, Deziel DJ, Telem DA, et al. Multi-society practice guideline and state of the art consensus conference on prevention of bile duct injury during cholecystectomy. Ann Surg. 2020;272(1):3-23; Surg Endosc.

2020;34(7):2827-2855.

5. Tornqvist B, Stromberg C, Akre O, et al. Selective intraoperative cholangiography and risk of bile duct injury during cholecystectomy.

Br J Surg. 2015;102(8):952-958.

6. Dip F, LoMenzo E, Sarotto L, et al. Randomized trial of nearinfrared incisionless fluorescent cholangiography.

Ann Surg. 2019;270(6):990-999.

Routine Use of Intraoperative Cholangiography Is Not Necessary for Reduction of Bile Duct Injury

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ontroversy exists regarding the effeccan mitigate the risk for bile duct injutiveness of routine IOC in the prery. In addition, they suggest that surgeons vention of bile duct injuries during with alternate expertise, such as laparocholecystectomy. However, the data do scopic ultrasound, can use such imaging not support its routine use. Correct idento mitigate risk in a similar fashion—suptification of the biliary anatomy by the porting the argument that identification operating surgeon is the critical step in of anatomy and not technique is the critiprevention. IOC is a technique for doing cal factor. There were no data to support Taylor S. Riall, so,1 similar to the critical view of safety a recommendation for routine IOC use in MD, PhD and other techniques. nonacute cholecystectomy.13 Professor and Interim Chair, The recommendation for routine IOC In addition, in studies examining rouDepartment of Surgery use comes from retrospective, compartine IOC (or any other technique for anaUniversity of Arizona College ative studies using administrative data tomic identification) to reduce bile duct of Medicine-Tucson that report nearly twofold higher rates injuries, it is not clear that improvements Tucson, AZ of bile duct injury in cholecystectomies are attributable to the technique itself. The performed without IOC.2-6 Populationimplementation of such policies requires based studies are subject to bias by indication.5 Without surgeon and team training. This heightened awareness clinical information, the intent of IOC is impossible of both the need for correct anatomic identification and to determine. Was IOC done as routine, to delineate the outcome measurement likely decreases injury rates, unclear biliary anatomy, to confirm injury or to detect regardless of the technique used. common duct stones?

To demonstrate this bias, Sheffield et al5 showed that The routine use of IOC to decrease bile in hospitals routinely performing IOC, the rate of injury was sixfold higher in cases when IOC was not per- duct injury during cholecystecomy is not formed. This is not because the surgeon didn’t do an indicated. That is not to say that IOC should IOC, but because they couldn’t due to severe inflammation and inability to identify the anatomy, thus con- not be used on an individual patient. founding the results. Similarly, in hospitals that use IOC infrequently, the rate of injury was fourfold higher Strasberg et al stress the importance of biliary idenin cases for which IOC was performed, suggesting IOC tification, rather than the specific technique used to may have been used to confirm suspected common duct achieve this critical step.1 They offer an analogy to a injury.5 Standard risk adjustment could not overcome hunter’s safe identification of an animal where, by regthis selection bias, but with instrumental variable anal- ulation, the hunter must see the head and torso of the ysis, which took advantage of the different rates of chol- animal, not only the legs, before firing. It is then up angiography across hospitals, the relative increase in to the hunter to correctly affirm what they see prior bile duct injury observed without IOC was attenuated to the irreversible step of firing their shot. Likewise, it and no longer significant.5 With a 0.2% to 0.5% inci- is essential that the surgeon be competent in whatevdence of bile duct injuries, single-institution studies are er technique they choose. There are documented cases underpowered to detect a difference in bile duct injury of a surgeon misreading a cholangiogram (no visualizarates. Furthermore, many single-institution studies are tion of the proximal ducts and confluence), with injucase series evaluating a single technique (IOC, critical ry occurring despite IOC use. Likewise, bile duct injury view of safety) without a comparator group.7-12 has occurred with documentation of the critical view In 2018, a multisociety consensus conference on the of safety due to incorrect affirmation based on what prevention of bile duct injuries addressed the role of the surgeon is seeing. Without correct affirmation, the IOC versus no IOC or other techniques to mitigate the technique does not matter. risk for bile duct injury.13 Pooled evidence from 14 studIn summary, the routine use of IOC to decrease bile ies with 2.5 million patients (largely from flawed popu- duct injury during cholecystectomy is not indicated. lation-based studies) evaluating the issue favored IOC This is not to say that IOC should not be used on an in the subgroup of patients with acute cholecystitis. Use individual patient. IOC should be part of the surgeon’s of IOC led to a threefold better recognition of injury, armamentarium of techniques used to achieve anabut not prevention. With very low certainty of evidence, tomic clarity. Consistency in the technique used by a the consensus group recommends that in patients with particular surgeon increases the likelihood that the suracute cholecystitis, liberal (but not routine) use of IOC geon will recognize when the anatomy is too obscured

for correct affirmation. When anatomic clarity is not achievable (regardless of technique used), this should lead the surgeon down alternate paths that reduce the risk for bile duct injury, including partial cholecystectomy, conversion to an open procedure, and obtaining additional intraoperative opinions prior to clipping or dividing any structures. An individual surgeon’s algorithm in this challenging setting should be consistent and based on their expertise.

References 1. Strasberg SM, Brunt LM. Rationale and use of the critical view of safety in laparoscopic cholecystectomy. J Am Coll Surg.

2010;211(1):132-138.

2. Fletcher DR, Hobbs MS, Tan P, et al. Complications of cholecystectomy: risks of the laparoscopic approach and protective effects of operative cholangiography: a population-based study.

Ann Surg. 1999;229(4):449-457.

3. Flum DR, Dellinger EP, Cheadle A, et al. Intraoperative cholangiography and risk of common bile duct injury during cholecystectomy. JAMA. 2003;289(13):1639-1644.

4. Flum DR, Koepsell T, Heagerty P, et al. Common bile duct injury during laparoscopic cholecystectomy and the use of intraoperative cholangiography: adverse outcome or preventable error?

Arch Surg. 2001;136(11):1287-1292.

5. Sheffield KM, Riall TS, Han Y, et al. Association between cholecystectomy with vs without intraoperative cholangiography and risk of common duct injury. JAMA. 2013;310(8):812-820.

6. Waage A, Nilsson M. Iatrogenic bile duct injury: a populationbased study of 152 776 cholecystectomies in the Swedish Inpatient Registry. Arch Surg. 2006;141(12):1207-1213.

7. Ausania F, Holmes LR, Ausania F, et al. Intraoperative cholangiography in the laparoscopic cholecystectomy era: why are we still debating? Surg Endosc. 2012;26(5):1193-1200.

8. Hamad MA, Nada AA, Abdel-Atty MY, et al. Major biliary complications in 2,714 cases of laparoscopic cholecystectomy without intraoperative cholangiography: a multicenter retrospective study. Surg Endosc. 2011;25(12):3747-3751.

9. Nuzzo G, Giuliante F, Giovannini I, et al. Bile duct injury during laparoscopic cholecystectomy: results of an Italian national survey on 56 591 cholecystectomies. Arch Surg.

2005;140(10):986-992.

10. Photi ES, El-Hadi A, Brown S, et al. The routine use of cholangiography for laparoscopic cholecystectomy in the modern era.

JSLS. 2017;21(3).

11. Yegiyants S, Collins JC. Operative strategy can reduce the incidence of major bile duct injury in laparoscopic cholecystectomy.

Am Surg. 2008;74(10):985-987.

12. Zacharakis E, Angelopoulos S, Kanellos D, et al. Laparoscopic cholecystectomy without intraoperative cholangiography. J Laparoendosc Adv Surg Tech A. 2007;17(5):620-625.

13. Brunt LM, Deziel DJ, Telem DA, et al. Notice of duplicate publication [duplicate publication of Brunt LM, Deziel DJ, Telem DA, et al. Multi-society practice guideline and state of the art consensus conference on prevention of bile duct injury during cholecystectomy. Ann Surg. 2020;272(1):3-23]. Surg Endosc.

2020;34(7):2827-2855. continued on the following page

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GREAT DEBATES

GENERAL SURGERY NEWS / DECEMBER 2020

Near-Infrared Incisionless Fluorescent Cholangiography Offers Better Visualization of the Biliary Tree

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performing laparoscopic cholecystectoince Carl Langenbuch’s first descripmy are the loss of tactile feedback with tion of an open cholecystectomy in laparoscopy in conjunction with the mis1831, the surgeon-on-call’s main concern identification of biliary structures and its has been how to prevent a bile duct injufrequent anatomic variation that can be ry. The introduction of IOC, by Pablo identified in 19% of cases.1 Mirizzi in 1931, significantly improved the morbidity and mortality of this operAlthough the incidence of bile duct ation, since surgeons could better visuinjury at 0.6% appears to be low, this Raul J. Rosenthal, alize and recognize the anatomy of the complication becomes a significant one MD, FACS, FASMBS extrahepatic biliary tree. Open choleif we take into account the potential for Clinical Professor of Surgery cystectomy became standard of care for major morbidity and mortality and the Cleveland Clinic Lerner College symptomatic or complicated gallstone fact that we perform well over 750,000 of Medicine at Case Western disease with a bile duct injury rate of laparoscopic cholecystectomies annually Reserve University, Ohio 0.3%. in the United States. Different approachErich Muhe’s introduction of the lapes have been proposed to avoid injuChairman, Department aroscopic approach in 1985 resulted in ry. Strasberg described the critical view of General Surgery a dramatic improvement in the overapproach of safety dissecting the Calot´s Director, General Surgery all outcomes of this operation. Patients triangle and identifying the cystic artery Residency Program Cleveland experienced a shorter hospital length of and extrahepatic biliary ducts.2 Other Clinic Florida, Weston stay by decreasing pain and wound comauthors proposed the routine use of fluplications. However, in parallel with the oroscopic IOC instead. Unfortunately, above-mentioned benefits of minimally invasive access regardless of implementing the above-mentioned techsurgery, the number of bile duct injuries doubled in fre- niques and approaches, the number of bile duct injuries quency, to 0.6%. Way et al demonstrated that the most remains unchanged. common reasons for bile duct injury occurrence while In 2009, Ishizawa et al first published the utilization of NIFC to better visualize the biliary tree when perA Surgeon and His Art forming biliary and liver surgery.3 This novel technique uses a fluorescent dye (indocyanine green) that, when activated by near-infrared light, allows the surgeon to properly detect structures during surgery that otherwise cannot be visualized with white light alone. Ishizawa demonstrated that NIFC delineated the cystic duct in all 52 patients, and the cystic duct‒common hepatic duct junction was visible before dissection of Calot’s triangle in 50 of the 52 patients.4 Different publications have described the utility of this technique in order to visualize the extrahepatic bile ducts. There is no doubt that the method is feasible and accurate.

But in order to establish the method as a standard “Off to His Paris Bookie,” A Watercolor by Gerald Marks, MD of care, or at least as a recommendation, it is imporThe 2014 World Congress of Surgical Endoscopy, in addition to tant to determine the real being a grand reunion of old friends, was a perfect opportunity impact of this technique to explore a favorite city in search of painting material. Paris is a during LC in different city of energetic urban activity ready for painting, and I walked the pathologies and patients. streets day after day shooting photos at random. I discovered I In a previously pubhad captured a candid image of a prototypical waiter hurrying to lished randomized consomeplace only to be imagined in an unknown back story. Was trolled trial by our group, he off to his bookie? Who knows? I have kept his image alive, Dip et al compared NIFC placing him in paintings in Rome and Mantova, and now where he plus white light with conbelongs—in Paris. ventional white light alone for the identification of

extrahepatic biliary anatomy during LC.5 The study determined that pre-dissection detection rates of extrahepatic biliary structures and anatomic landmarks were significantly superior in the NIFC group compared with the one using white light alone. The better visualization of anatomic landmarks included accessory ducts, cystic ducts, right hepatic duct, common hepatic duct, common biliary duct, cystic–common bile duct junction and cystic–gallbladder junction.

Furthermore, following dissection, similar differences were observed for all structures except cystic ducts and cystic–gallbladder junction. Although not significant, there were only two bile duct injuries in this study and three conversions, all of them in the group that used white light alone.

When implementing the critical view of safety as a surgical approach to avoid a bile duct injury, extensive dissection needs to be performed, which by itself can result in injury.

There are multiple reasons why NIFC should be implemented on a routine basis when performing LC. It is relatively inexpensive compared with IOC; it does not require radiation and because of that, it can be used in pregnant women; it provides the surgeon with a direct image that can be repeated endlessly without the need for radiation or cannulation of the cystic duct; the image is real and does not require interpretation as it does for IOC; it gives some tactile sensation back to the surgeon since he can touch the structure that is lighting up; and finally, what is more important, it does not require extensive dissection and it is incisionless. When implementing the critical view of safety as a surgical approach to avoid a bile duct injury, extensive dissection needs to be performed, which by itself can result in an injury. Similarly, when performing an IOC, the surgeon must make an incision to cannulate the cystic duct, the latter becoming a bile duct injury if this is the incorrect anatomic location.

NIFC should be implemented routinely during LC, not because it should replace the critical view of safety or selective use of IOC, but because it becomes a critical complement to the above-mentioned maneuvers to prevent bile duct injury occurrence.

■ References 1. Way LW, Stewart L, Gantert W, et al. Causes and prevention of laparoscopic bile duct injuries analysis of 252 cases from a human factors and cognitive psychology perspective. Ann Surg.

2003;237(4):460-469.

2. Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995;180(1):101-125.

3. Ishizawa T, Bandai Y, Kokudo N. Fluorescent cholangiography using indocyanine green for laparoscopic cholecystectomy: an initial experience. Arch Surg. 2009;144(4):381-382.

4. Ishizawa T, Bandai Y, Ijichi M, et al. Fluorescent cholangiography illuminating the biliary tree during laparoscopic cholecystectomy. Br J Surg. 2010;97(9):1369-1377.

5. Dip F, LoMenzo E, Sarotto L, et al. Randomized trial of nearinfrared incisionless fluorescent cholangiography. Ann Surg.

2019;270(6):990-999.

If you have suggestions for topics for future Great Debates, contact the editor at khorty@mcmahonmed.com.

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16

OPINION

GENERAL SURGERY NEWS / DECEMBER 2020

Metabolic Surgery in the Era of COVID-19 continued from page 1

humane dedication, elective surgery was segmented into urgent (e.g., cancer surgery) and not so urgent (e.g., cosmetic surgery). With increasing surgical inactivation and the indefinite extension of the COVID-19 pandemic, many formerly elective procedures have gradually been allowed to be added to the operating room schedule.

Where does metabolic/bariatric surgery belong in the spectrum of emergency, urgent and elective surgery, especially if elective surgery is defined as free of health risks by a prolonged wait?

One categorization of elective operative procedures is to classify them as reparative, prophylactic, curative and lifesaving, with some operations overlapping several categories. Of the most common operative procedures performed in the United States, many are orthopedic and reparative in nature, such as knee arthroplasty. Certain reparative procedures are prophylactic as well, such as coronary artery bypass grafting, and some are primarily prophylactic, like colonic polypectomy; others are curative, an example being closure of a patent ductus arteriosus. There are also a few procedures that can be said to qualify as lifesaving, such as early breast cancer surgery.

Today the number of metabolic/bariatric operations performed in the United States annually is about 250,000, just short of the number of cholecystectomies at 300,000. Thousands of articles, over six decades, have been published in the peer-reviewed literature, including numerous randomized controlled clinical trials and systemic reviews and meta-analyses, demonstrating metabolic/bariatric surgery efficacy, safety, resolution of obesity comorbidities, improvement of quality of life and increasing life expectancy. Metabolic/bariatric surgery procedures clearly are reparative, prophylactic, curative and lifesaving concurrently. Further, the disease of obesity with its comorbidities, unless treated by metabolic/ bariatric surgery, is a malignancy that robs the afflicted of the pleasures of life en route to a premature death.

Metabolic/bariatric surgery is certainly reparative. It converts morbid obesity to lesser obesity, overweight, or at times, normal weight. It resolves up to 70% to 90% of the metabolic diseases of type 2 diabetes, hyperlipidemia and hypertension—the precursors of atherosclerotic cardiovascular disease—as well as mitigating the anatomic orthopedic and sleep apnea problems associated with obesity. It cures skin eruptions. It restores normal menstrual and reproductive functions. It reverses non-alcoholic

Cartoon by Walter Pories, MD

steatohepatitis. It improves exercise tolerance and quality of life. It has even been shown to improve mentation.

Metabolic/bariatric surgery is prophylactic, serving to prevent the metabolic syndrome and the other problems listed above when they are in their early stages or prior to becoming manifest. The evidence is definitive that metabolic/bariatric surgery markedly lowers the incidence rates of several cancers.

Once a metabolic/bariatric operation is decided upon, it belongs in the urgent category. This conclusion is warranted by the vast, powerful, statistically significant data available in the literature.

This conclusion is even more justified in the COVID-19 pandemic era.

If the disease of obesity is no longer manifest; if type 2 diabetes, once present, does not recur; if lipids are permanently lowered; if high blood pressure is reduced; if sleep apnea is relieved; if walking and other daily activities are improved—we can truly say that metabolic/bariatric surgery deserves to be considered as curative.

Combining the repairs, cures, resolutions and functional improvements generated by metabolic/bariatric surgery, in particular pertaining to cardiovascular processes, it is reasonable to assert that metabolic/bariatric surgery is lifesaving. Literature proof of increased life expectancy after metabolic/bariatric surgery may be found in the current paper from the cardinal Swedish Obese Subjects Study (N EngI J Med 2020;383:15351543), in support of well over a dozen previous publications providing hard data for the same conclusion.

Yet, certain of our internist colleagues would diminish the therapeutic impact of bariatric surgery and, thereby, increase the deadly outcomes of obesity, by linguistic minimization. These internists will only publish the work of metabolic/bariatric surgeons if they do not use the term “morbid obesity,” and instead substitute “severe obesity.”

However, they have no difficulty with “malignant hypertension,” or “end-stage heart failure”—conditions amenable to medical therapy. Recently, these semanticists have asked us not to refer to the “obese patient,” comparable to the manner in which they feel free to speak of the “cancer patient” or “diabetic patient,” in order to emphasize the seriousness of these afflictions. They prefer that we use instead, “the patient with obesity,” as if obesity were an attached attribute and not characteristic of a state of great ill health and diminished life expectancy, a disease not an ancillary trait, a disease curable by surgery.

Language is not a trivial matter. Words reflect reality and also shape reality. If we diminish the impact of obesity, we remove it from being considered a disease, truly a morbid disease, to being a social subject of diversity. We cannot sacrifice truth in language because such an acquiescence is a major disservice to our patients. We must not be persuaded by “internists with hypocrisy.”

The definition of metabolic surgery as “the operative manipulation of a putatively normal organ or organ system to achieve a biological result for a potential health gain” (Buchwald H, Varco RL. Metabolic Surgery.

Grune & Stratton; 1978) has found general acceptance.

In addition to bariatric surgery, this discipline encompasses gastrectomies and vagotomies for peptic ulcer

disease, splenectomy for idiopathic thrombocytopenia, portal diversion for glycogen storage disease, endocrine ablations for metastatic malignancies, pancreas transplantation for diabetes, carotid body ablations and sympathectomies for hypertension, and partial ileal bypass for hyperlipidemia, as well as perirenal neuroablation and gastric stimulation for diabetes, cervical single vagus nerve stimulation for refractory depression, and several non‒weight-losing gastrointestinal operations designed to mitigate type 2 diabetes. Indeed, truly bariatric procedures, including the Scopinaro biliopancreatic diversion, have been demonstrated to eliminate type 2 diabetes with minimal weight loss in overweight but not obese patients.

Certain metabolic operative procedures are elective in the sense that they can wait to be performed without a definitive threat to health or life. Metabolic/bariatric surgery is definitely not among them. Once a metabolic/bariatric operation is decided upon, it belongs in the urgent category. This conclusion is warranted by the vast, powerful, statistically significant data available in the literature. This conclusion is even more justified in the COVID-19 pandemic era.

It has been well documented that obesity, diabetes and hypertension are primary risk factors for the severity of, and mortality from, COVID-19. In essence, these factors equate to the metabolic syndrome, a manifestation of the disease of morbid obesity, best and successfully treated by metabolic/bariatric surgery. If there were a pill or an injection that could achieve the reparative, prophylactic, curative and lifesaving results of metabolic/bariatric surgery, every physician, federal and state governments, the media and the public would unanimously advocate this therapy. The natural human fear of and reluctance to undergo any form of surgery is universal. That fear has impeded the consideration of using metabolic/bariatric surgery as an equivalent to nonsurgical management. While it is, of course, impossible to operate on the entire population that might benefit from surgical therapy, it is feasible to operate on that fraction of patients most in need of its benefits. Metabolic/bariatric surgery, therefore, is urgent surgery during the COVID-19 era.

It will be argued that weight loss takes time, but we must consider that the COVID-19 pandemic will last for a considerable period of time as well—at least two years— and the recurrence of a vaccine-resistant pandemic surge is possible, as well as future highly infectious viral pandemics. In addition, type 2 diabetes reversal—“cure”—occurs days after the operative metabolic/bariatric surgery procedure (Ann Surg 1995;222[3]:339-350). Hypertension and hyperlipidemia also respond rapidly; blood pressure and blood lipid concentrations normalize within weeks.

Currently, an American College of Surgeons outreach initiative exists to acquaint surgeons, physicians and the public with both the concept and applications of metabolic surgery. The organization is also advocating a staggered, intelligent return to the operating room.

In selecting the elective operative procedures for this affirmative transition, metabolic/bariatric surgery—for its prophylactic, curative and lifesaving effects—should ■ be considered as urgent.

—Dr. Buchwald is a professor of surgery and biomedical engineering, and the Owen H. and Sarah Davidson Wangensteen Chair in Experimental Surgery (emeritus), at the University of Minnesota, in Minneapolis. His articles appear every other month.

IN THE NEWS

DECEMBER 2020 / GENERAL SURGERY NEWS

Reproductive

How to mitigate: Keep exposure as low as possible, mandate use of protective gear and maintain distance from the radiation source. Women who are pregnant should wear fetal dosimeters under their protective gowns near their abdomen, and have access to counseling by a qualified expert.

continued from page 1

Surgical Smoke What’s the risk: Although much of the research on surgical smoke focuses on its components and does not focus on physicians, experts are getting a better picture of its potential health risks to providers. continued on the following page

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also plain old stress: “Surgical specialties are inseparably linked to physical and emotional burden, which increases the risk of burnout and threatens mental well-being.”

Unfortunately, the OR is home to several other potential reproductive hazards. Some, such as radiation and strenuous working conditions, are likely well known. However, others may be less familiar, like the hyperthermic intraperitoneal chemotherapy used in peritoneal carcinomatosis, and methyl methacrylate, a form of acrylic resin that’s commonly used in orthopedic surgeries.

Most of the data linking these OR exposures to pregnancy outcomes are retrospective, making it hard to draw conclusions about dose-response relationships with reproductive health, said Rose H. Goldman, MD, MPH, an associate professor of environmental health at the Harvard T.H. Chan School of Public Health, and an occupational health physician at the Cambridge Health Alliance, both in Massachusetts. Barring pregnant surgeons from the OR isn’t fair, either, she added.

The best way forward, Dr. Goldman said, is to limit exposures to the extent possible, and at a minimum, following guidelines from regulatory agencies, so it’s safer for women—and men—to operate during their reproductive years. “We need to not stigmatize female surgeons about it, and begin to look at the evidence and have a dialogue and some rational decision making. And look at our operating rooms and see how we can better control some exposures.”

Here is a list of some reproductive risks present in the OR, and suggestions for how to mitigate them.

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GET CONTROL EARLY

Working Conditions What’s the risk: In some studies, working more than 40 hours per week has been linked to increased risk for preterm delivery and miscarriage; night shifts are associated with preterm delivery and miscarriage.

How to mitigate: Educate surgeons about the potential risks and provide alternative conditions that aren’t unfairly restrictive.

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IN THE NEWS

GENERAL SURGERY NEWS / DECEMBER 2020

Reproductive

Community Surgeons Offer Tips on Practice

continued from the previous page

continued from page 1

Studies of reproductive risk have associated particulate matter with low birth weight and preterm labor; toluene with congenital defects, cognitive problems and infertility; benzene with childhood leukemia; and 1,2-dichloroethane with miscarriage and infertility.

How to mitigate: Use a ventilation system, employ smoke activators with adequate capture velocity (31-46 m per minute), cut back on surgical smoke as much as possible, and use a high-filtration mask for standard procedures and an N95 mask in the presence of aerosols.

Cynthia L. Geocaris, MD, finished residency in 2000, and joined her father in a surgical practice in Wisconsin, where her brother worked as a surgical assistant and her mother was the office manager. Dr. Geocaris scrubbed cases with her father and worked as a surgical assistant for other surgeons. “Assisting others is extremely valuable. You get to learn new tricks that you might not have picked up,” she said.

In 2005, she started a robotic surgery program, one of the first in the country. Five years later, her father retired and died from cancer soon after. While she was grieving her father’s death, the hospital switched to an employment model—“a business decision for the hospital that coincided with bad timing for me,” Dr. Geocaris said. The following months were the lowest point in her career, she said. She felt like she lost the family business.

Dr. Geocaris moved to a new job that felt at first like the perfect job: She did 16,000 RVUs a year, earned a high income and started a robotics mentorship program. But her home life suffered. She was exhausted and on call most weekends, with little time for her husband and their four kids. “I learned that family and fun were a little bit more important than my career,” she said.

In 2019, she joined residency colleagues at the Surgical Associates of Neenah in Neenah, S.C. It provided a better work–life balance with more supportive colleagues, she said.

Dr. Geocaris urged surgeons to develop collegial relationships with referring doctors, colleagues and competitors in the community. “Our job is to be there for our patients and to elevate the level of care for all of the patients in our community.”

Waste Anesthetic Gases What’s the risk: There is a potential for miscarriage, congenital abnormalities and infertility.

How to mitigate: Follow recommendations of the U.S. Occupational Safety and Health Administration, use ventilation and anesthetic gas‒scavenging systems, maintain equipment, avoid high flow rates and other high-waste techniques, and monitor breathing zone atmospheric gas levels.

Hyperthermic Intraperitoneal Chemotherapy What’s the risk: Studies of occupational exposure to chemotherapy have shown increased risks for miscarriage, low birth weight, congenital abnormalities and infertility.

How to mitigate: Inform surgeons who are pregnant or trying to conceive that current recommendations advise not participating in HIPEC administration, train them on proper use and handling of antineoplastic agents, and any physician in direct contact with HIPEC should use triple gloves and change them every 30 minutes.

Methyl Methacrylate What’s the risk: High exposures in animals are linked to skeletal abnormalities and growth restriction.

How to mitigate: Install laminar flow ventilation, use surgical hooded helmets, and use vacuum cement mixing systems and local suction during preparation.

Female surgeons can take on less physically demanding activities during pregnancy without interrupting their career goals, said Joanna Kacperczyk-Bartnik, MD, an obstetrics and gynecology resident at the Medical University of Warsaw, in Poland. (One example, Ms. Szczęsna said, would be avoiding the night shift, either in person or on call.) “More emphasis on the scientific work, attendance at theoretical courses, training in nonsurgical wards, gaining skills essential in the diagnostic process and follow-up care are the examples of much safer options within the residency curriculum than the OR,” Dr. Kacperczyk-Bartnik said.

Although the data focus on female reproductive issues, men need to be aware of the risks and advocate for change, Dr. Goldman said. It’s very possible that some of the risks to female reproduction also affect men, so limiting exposures is “going to be good for everybody,” she said, “because there are the risks we know, and the risks we don’t know. But when we control exposures, we basically control unknown risks, as well.”

■ Source: JAMA Surg 2020;155(3):243-249.

Allison J. Porter, MD, is a general surgeon at Skagit Regional Health in Skagit, Wash. After fellowship, she was drawn to rural surgery. She liked the access to nature, lower cost of living and less frenetic pace. She also was motivated by the need for surgeons in rural America.

“Surgeons in rural areas are aging and patients in rural areas are often impoverished, and they have a really hard time getting to urban areas to seek care,” she said.

Dr. Porter works in a 137-bed hospital and takes call approximately one in seven nights, dividing her time between general and benign foregut surgery. Her practice is rural but not isolated: She’s located one hour from a major city and can access subspecialty care.

The benefits of a rural surgery practice are often overlooked, Dr. Porter said. “You do a lot of your own decision making, it’s very high quality of life and there can be a lot of satisfaction gained when you are taking care of people who are truly underserved.”

The call burden can be higher than in urban settings, and personnel and equipment are limited compared with large city hospitals, she said. She noted that smaller hospitals sometimes do not provide funding for surgeons to attend major conferences.

She encouraged surgeons who are looking at joining a rural practice to review their contracts for medical staff bylaws and call frequency. Surgeons should clarify what happens to patients when no other surgeon is available, she said.

One of the biggest challenges in her job is deciding when to refer out. “It’s affected by your own skill set. But it’s even more affected by what the resources are at your hospital, what the patient characteristics are and even geography,” Dr. Porter said. “Sometimes you just have to take care of patients because they’re there and they can’t go elsewhere.”

On the other side of the country, David Earle, MD, decided to set out on his own after 18 years in academic practice. He had become frustrated with hospital management after they urged him to spend less time with individual patients and increase his productivity, he said.

“I couldn’t align my goals with the patient [with the hospital’s goals] and it put the outcomes at a much higher risk for failure,” said Dr. Earle, whose practice was dedicated to complex abdominal wall reconstruction and benign foregut surgery.

In 2018, he started the New England Hernia Center, a solo private practice. The transition was challenging, he said. “You lose a guaranteed paycheck,” Dr. Earle said.

“In exchange, you can expect to gain your autonomy.”

He relied on other opportunities for income as he built his practice, including a year with the FDA and doing several locum tenens. “It’s a little weird that you don’t really work anywhere and you’re kind of moving around,” he said. “But this is not survival of the fittest; it’s those who can adapt.”

Dr. Earle advised surgeons who are looking to start out on their own to carefully consider the location of their practice—looking at geography, market share and building design, as well as options to buy, lease or share.

Dr. Earle is also an associate professor of surgery at Tufts University School of Medicine in Boston, and an editorial advisory board member of General Surgery News.

Benjamin Clapp, MD, is a private practice surgeon in El Paso, Texas. In his solo bariatric practice, he shares call coverage with a general surgeon colleague through an informal relationship. This way, he can travel to meetings and take holidays, and the pair alternates call coverage on weekends.

Five years ago, Dr. Clapp joined Texas Tech HSC Paul Foster School of Medicine as a clinical assistant professor of surgery. The unpaid faculty position gives him access to university resources, which he relies on for his research, and enables him to teach clerkship students and residents.

He stressed that private practice surgeons can lead studies and publish research, although it is easier with the support of an academic institution. Dr. Clapp has authored a number of peer-reviewed publications over the past decade, including papers on anatomic landmarks in sleeve gastrectomy and large analyses of national databases.

He said the main challenge in his practice is loneliness. “You feel like you’re cut off from the team approach that you had as a resident or a fellow,” Dr. Clapp said. He believes that isolation is a key factor in burnout among private practice surgeons.

To prevent isolation, Dr. Clapp engages with local medical groups and national societies, and works at maintaining a vibrant home life. He recommended that surgeons read two or three journals monthly in order to stay at the top of their field. Many journals are provided for free through society memberships, he noted.

Online resources such as closed Facebook groups and Twitter also can help build professional relationships, Dr. Clapp said.

He stressed the benefits of attending meetings in person and connecting with other surgeons, including asking questions of presenters. “It’s important to show up, pay attention, look through the syllabus so that you can plan your day out as to what you want to get out of it,” ■ Dr. Clapp said.

IN THE NEWS

DECEMBER 2020 / GENERAL SURGERY NEWS

Deadly Delays in CRC Screening During COVID-19 Pandemic

By MARCUS A. BANKS

D

elays in colorectal cancer screenings during this year’s coronavirus pandemic will result in a 12% increase in cancer deaths over the next five years, Italian researchers have found.

During the pandemic, many people have delayed elective health screenings, mostly due to halting of screening programs. Although colorectal cancer is highly treatable if caught early, it is more difficult to manage the later it is detected.

“In the wake of possible new pandemics or surges of COVID-19, we need to have an unbroken prevention path for high-impact diseases,” Luigi Ricciardiello, MD, an associate professor at the University of Bologna, in Italy, and lead author of the study, said. Dr. Ricciardiello’s group, which included researchers at the University of Parma, Humanitas University, the University of Bergamo and the IRCCS Fatebenefratelli in Brescia, presented their findings at the 2020 virtual United European Gastroenterology Week (abstract P1470).

Before the pandemic, Italian health authorities sent 500,000 notices per

month to patients encouraging colorectal cancer screenings, a concerted approach that Dr. Ricciardiello dates to 2004 and 2005. This effort has generated a trove of data about how quickly people were screened after receiving this notice, as well as of how many detected cancers were at early, easier-to-treat stages (stage I or II).

Ricciardiello and his colleagues used these data to predict the long-term impact of screening delays linked to the pandemic.

According to their model, at seven to 12 months of screening delays, 29% of detected colorectal cancers will be advanced (stages III-IV). Screening delays of more than a year will result in 33% of cancers being advanced. The longest delays equate to an increase in deaths of 11.9% in the next five years compared with catching advanced cancer earlier.

“The risk is to go backward,” Dr. Ricciardiello said. “In many regions screening has resumed; however, in many areas the situation is very complicated, especially in the South [of Italy]. We could face a situation like in the early 2000s, the prescreening era.”

“There are many health conditions that we are probably going to see higher

rates of in the future, because they are not getting the attention that they warrant and need now,” Folasade May, MD, PhD, MPhil, the director of the Melvin and Bren Simon Gastroenterology Quality Improvement Program at UCLA Health, in Los Angeles, said.

“We are probably going to see an uptick in the number of cancers over time, due to delays in health care and particularly delays in screening.”

Dr. May was not involved in the Italian research, but her own work at UCLA also found a drop in screening rates. In a presentation at the 2020 annual meeting of the American College of Gastroenterology, Dr. May and her colleagues reported that colonoscopies plummeted at the

beginning of the pandemic and that fecal immunochemical tests (FITs) also declined dramatically (poster P0761).

Between Jan. 29 and March 17—just before UCLA Health ceased elective colonoscopies as the pandemic took hold— its physicians conducted an average of 33 colonoscopies or ordered 31 FITs per day. From March 18 to May 4, the number of colonoscopies plummeted to essentially zero per day (0.22). The number of FITs ordered scraped zero between March 18 and April 15, too, before beginning to rebound. By May 4, UCLA Health was averaging 12 FITs per day, while colonoscopies were still essentially nil.

While Dr. May said FIT is a viable screening tool for many patients, she also noted that endoscopy units are much safer for patients and providers alike than at the start of the pandemic. Patients must show proof of a recent negative COVID-19 test to undergo a colonoscopy, and providers are now outfitted with personal protective equipment from head to toe. Although delaying a colonoscopy in March or April this year made sense, patients now do not need to keep putting off the procedure.

■

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OPINION

A Winding Path

By IOANA BAIU, MD, MPH B

A

s I lay on the cold steel table, petrified by the sharpness of the scalpel that was threatening my ruptured appendix, my body shuddered. Was the bribe in the little white envelope sufficient? Was this what “free” health care really meant? I had no voice.

I was afraid.

When my mother handed my doctor an envelope with money prior to my surgery, I had become aware of the hidden cost of health care that exists in my birth country of Romania. With almost no preventive care and limited access to medications and doctors, the country had slipped into a tacit admission that only money handed under the table could buy some of the most basic medical care. Yet, in a system so convoluted and perverse, I realized surgery still held the power to

make an actual change. What happens in the operating room often transcends corruption. The surgeon reassured me that everything would be better when I woke up. So, I closed my eyes and dreamed of a world in which things would indeed be “better.”

Having spent the first few years of my life under a Communist regime and in the aftermath of its demise, I grew up with a distinctive view of the world. The journey that I embarked upon when my

family emigrated revealed an unexpected dichotomy between the impoverished East European and the Western worlds, where, in spite of seemingly abundant resources, the system is broken. Working at hospitals in the United States revealed the brutal reality of patients whose health care had been delayed so long that their only options were now surgical. In a world that has lost nearly all faith in the health care system, the surgeon is often the last resort who can offer hope for improvement. The desire to make such a meaningful and tangible effect in patients’ lives was pivotal to my decision to become a physician.

As a medical student, I fell in love with surgery. However, my focus on public health steered me toward a career in pediatrics. I was encouraged by the potential decisiveness and long-term impact of intensive care, which would allow me to combine medicine with surgery and public health. The month I matched for my pediatrics residency, I was working in a pediatric burn unit. I quickly realized that the most important decisions were actually occurring in the OR, and I soon knew that this was where I needed to be.

On a cold Tuesday afternoon, a flight arrived from Ecuador with a hot, charred body of a 4-year-old girl, who had suffered severe burns to more than 90% of her body. Her country was similar to mine in that it lacked adequate health care and that being hospitalized was often a death sentence. Her father, who had run into the house to rescue her, had already succumbed to his injuries.

Despite being at an American hospital, her chances of survival were dismal. The trauma OR was more than 100 degrees inside. Beads of salty sweat were crowding on my forehead. I joined the trauma surgeon as a first-assist. We had very little time to place a central line, debride and graft. Miraculously, after dozens of

OPINION

Throughout my training, I became more aware of the increasing power of my own voice, advocating on behalf of those who could not do so on their own. Despite this, my sickest patients were saved neither by my voice nor by medications. Ultimately, it was by the hands of a surgeon.

21

of another exciting and intricate journey. I expected the road ahead to be as difficult and challenging as it would be rewarding and fulfilling.

Contemplating the past few years unraveled a pattern of key turning points and elucidated the critical importance of mentors who guided me along building my own unique path. The profound influence of those with whom we work, admire or detest molds our view of the world and aspirations for the future. As I stood next to the cold steel table holding my patient’s trembling hand, I shuddered. The winding path took me here today and, in this moment, now, I was her surgeon. And I had a voice. ■ —Dr. Baiu is a PGY-5 general surgery resident at Stanford University, Palo Alto, Calif.

Free CME/CE now available! visits to the OR, the patient survived.

Over time, her hypertrophied dermal scars have been smoothed over by the plastic surgery team. Nevertheless, her body will always be covered with scars, she will never reach her peak height, and she will never see her father again. But she could look forward to a new day. As I started residency, I knew this was the role I would want to play as a physician.

Throughout my training, I became more aware of the increasing power of my own voice, advocating on behalf of those who could not do so on their own.

Despite this, my sickest patients were saved neither by my voice nor by medications. Ultimately, it was by the hands of a surgeon. I yearned to join the surgeons in the OR, as this is where the impact on patient care seemed greatest.

Although I enjoyed caring for perioperative patients in the ICU, I missed the ability to operate and make acute surgical decisions in the OR. Over the past two years, I have accumulated a box full of thank-you notes, drawings, pictures and plastic jewelry made by my patients. The souvenirs that stand out the most come from patients whom I was able to help in a concrete way, with stitches, soft tissue repairs, wound dressings. I wanted to be the physician who, in every context, could make that tangible, decisive and critical difference.

Pursuing a career in surgery was the next necessary step in my career. Having been a patient myself, a tireless advocate for vulnerable populations, a passionate and determined resident caring for some of the world’s sickest children, and a fully trained pediatrician, I had a deeply unique perspective to patient care. My journey was from the corrupt and impoverished Eastern Europe, to medical school and pediatrics residency, strength of character and determination. Starting a new residency was just the beginning

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IN THE NEWS

GENERAL SURGERY NEWS / DECEMBER 2020

Prehab and Rehab continued from page 1

don’t spend enough time talking about our patients and thinking about how to get them to and through surgery as safely as possible,” Dr. Telem said. “If you think of surgery as a marathon, we need to spend time training our patients to get through this insult to their bodies and help them recover better.”

Preoperative optimization, or “prehabilitation,” is a process to mitigate patient risks before surgery. Studies have shown that delaying surgery when possible to manage modifiable risk factors, such as diabetes, obesity, smoking and substance abuse, preoperatively can reduce surgical complication rates up to 40% (Surgery 2016;160[5]:1189-1201), she said. In a review of elective hernia repairs in the state of Michigan (JAMA Netw Open 2019;2[11]:e1916330), nearly 25% of patients were found to have a modifiable risk factor, which increased rates of complications and added an estimated $60 million to episode-of-care spending. High BMI alone added about $1,300 per case, for a total of nearly $1.2 million.

Dr. Telem interviewed 21 practicing surgeons in the state (JAMA Netw Open 2020; in press), identifying three barriers to more widespread adoption of preoperative optimization. The first is financial: Surgeons don’t get paid if they don’t operate, and some expressed concern about loss of referrals or reputation damage by putting off patients. In addition, some surgery practices lack the infrastructure or knowledge to put such programs in place, while others may have organizational barriers or clinicians who like to do their own thing.

“Preoperative optimization is a great target for change and a great target to improve the quality of patient care,” Dr. Telem said. “Just telling surgeons to do best practice isn’t going to work if we don’t address the multifaceted

‘If you think of surgery as a marathon, we need to spend time training our patients to get through this insult to their bodies and help them recover better.’

—Dana Telem, MD, MPH barriers that impede people from doing the right thing.”

Multipronged strategies are needed to change behavior and fill the gap between evidence-based practice and implementation, she said. She and others in the state are working with their local Blue Cross Blue Shield partner to release a pay-for-performance measure around patient preoptimization, as soon as 2021. They also are looking to establish provider-led trainings to deploy a statewide preoperative patient optimization program, with help available for on-site facilitations.

On the recovery side, physical therapy may help patients bounce back sooner after hernia repair and potentially other laparoscopic procedures, said Howard Levinson, MD, FACS, an associate professor of plastic and reconstructive surgery at Duke University, in Durham, N.C. Surgeons should think of the linea alba as the central tendon of the abdomen, Dr. Levinson said. Cutting through or disrupting that tissue can be akin to how orthopedic surgeons handle tendon reconstruction, he said.

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“You would never expect to fix an extremity or tendon and not have patients see a physical therapist, yet we all the time operate on the abdominal wall and don’t have people see a physical therapist,” he said. “It’s time for a change.”

His center, so far, has followed about 100 patients after surgery referred to physical therapy for a customized low-, medium- or high-intensity rehabilitation program based on their needs and preoperative functioning levels. The programs combine walking with exercises to strengthen core muscles and provide a point of contact for patients who have questions about exercise and activity. Without guidance, patients may do either no activity or too much, he said. Physical therapy programs also can play an early and important role in pain management, he noted.

Investigators are analyzing data now and looking to expand to collaborative centers.

Enhanced recovery after surgery (ERAS) pathways also can do more, said Michelle Fillion, MD, FACS, a surgical oncologist with New Hanover Regional Medical Center, in Wilmington, N.C. The pathways, started in colorectal surgery to decrease perioperative stress, pain, and GI dysfunction and accelerate recovery after surgery, have been gradually expanding to other areas.

The ERAS Society now has specific pathways recommended for some 14 procedures, she said, most recently including neonatal intestinal surgery.

Implementing these programs successfully into other areas and health systems requires several factors, Dr. Fillion said. These include buy-in from hospital or health-system leadership; dedicated ERAS coordinators, nurses and staff; a protocolized approach for patient optimization, such as referring patients with angina to cardiology; expanding preoperative optimization to include nutrition, fragility and cognitive function assessments; and the involvement of dedicated hospitalists and anesthesiologists to help with risk assessment.

Beyond implementation, ERAS program leaders need to do a better job with compliance, reporting that compliance, and auditing programs to assess where improvements can be made, Dr. Fillion said. A 2015 meta-analysis (Br J Surg 2015;102[13]:1594-1602) of 50 publications about enhanced recovery protocols found that less than 50% reported compliance data.

“If we can learn and track our own data, and how well we’re applying these ERAS pathways, they can continue to be modified and tailored overall to improve the care ■ of the surgical patient,” she said.

Dr. Telem reported research funding from Medtronic. She is an editorial board member of GSN. The other speakers reported no relevant financial conflicts of interest.

DECEMBER 2020

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These products are supplied sterile and are intended for single patient one-time use only.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS These products should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.

WARNINGS Do not resterilize. Discard all open and unused portions of these devices.

Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.

Do not reuse once the surgical mesh has been removed from the packaging and/or is in contact with a patient. This increases risk of patient-to-patient contamination and subsequent infection.

For STRATTICE™ RTM Extra Thick, do not use if the temperature monitoring device does not display “OK.” PRECAUTIONS Discard these products if mishandling has caused possible damage or contamination, or the products are past their expiration date. Ensure these products are placed in a sterile basin and covered with room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body.

PRECAUTIONS (Continued) Place these products in maximum possible contact with healthy, wellvascularized tissue to promote cell ingrowth and tissue remodeling. These products should be hydrated and moist when the package is opened. If the surgical mesh is dry, do not use.

Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation.

Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh. In large abdominal wall defect cases where midline fascial closure cannot be obtained, with or without separation of components techniques, utilization of the surgical mesh in a bridged fashion is associated with a higher risk of hernia recurrence than when used to reinforce fascial closure.

For STRATTICE™ RTM Perforated, if a tissue punch-out piece is visible, remove using aseptic technique before implantation.

For STRATTICE™ RTM Laparoscopic, refrain from using excessive force if inserting the mesh through the trocar.

STRATTICE™ RTM, STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are available by prescription only.

For more information, please see the Instructions for Use (IFU) for all STRATTICE™ RTM products available at www.allergan.com/StratticeIFU or call 1.800.678.1605.

To report an adverse reaction, please call Allergan at 1.800.367.5737.

For more information, please call Allergan Customer Service at 1.800.367.5737, or visit www.StratticeTissueMatrix.com/hcp.

References: 1. Garvey PB, Giordano SA, Baumann DP, Liu J, Butler CE. Long-term outcomes after abdominal wall reconstruction with acellular dermal matrix. J Am Coll Surg. 2017;224(3):341-350. 2. Golla D, Russo CC. Outcomes following placement of non-cross-linked porcine-derived acellular dermal matrix in complex ventral hernia repair. Int Surg. 2014;99(3):235-240. 3. Liang MK, Berger RL, Nguyen MT, Hicks SC, Li LT, Leong M. Outcomes with porcine acellular dermal matrix versus synthetic mesh and suture in complicated open ventral hernia repair. Surg Infect (Larchmt). 2014;15(5):506-512. 4. Booth JH, Garvey PB, Baumann DP, et al. Primary fascial closure with mesh reinforcement is superior to bridged mesh repair for abdominal wall reconstruction. J Am Coll Surg. 2013;217(6):999-1009. 5. Richmond B, Ubert A, Judhan R, et al. Component separation with porcine acellular dermal reinforcement is superior to traditional bridged mesh repairs in the open repair of significant midline ventral hernia defects. Am Surg. 2014;80(8):725-731.

Allergan® and its design are trademarks of Allergan, Inc. STRATTICE™ and its design are trademarks of LifeCell Corporation, an Allergan affiliate. © 2019 Allergan. All rights reserved. STM122822 04/19