April SE 2015

The Independent Newspaper for the General Surgeon

INTERNATIONAL EDITION

Volume 3 • Number 1 • 2015 GENERALSURGERYNEWS.COM

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Opinion

Robotics for General Surgical Procedures

Bariatric Surgeons Aim To Reduce Readmissions

A Unique International Hernia Meeting

Hepatopancreatobiliary Surgery B Y C HRISTINA F RANGOU

B Y C HRISTINA F RANGOU

B Y G IAMPIERO C AMPANELLI , MD

SAN FRANCISCO—Amer H. Zureik eikat, MD, and his colleagues at the Un University of Pittsburgh have accum mulated the largest series of robotic hepah topancreatobiliary (HPB) proocedures in the world, having performed almost 500 robotic HPB surgeries since 2010.

At the 2014 Clinical Congress of the American College off Surgeons, Dr. Zureikat presented his experience with robotic surgery, outlining the pros and cons of using the robot in HPB surgery. After his presentation, he spoke with General Surgery News to offer his thoughts on the role of robotic technology in one of the most complex areas of general surgery.

GSN:: You’ve been using the robot now for more than five years. Can you

“We did not find any tendency toward a higher hazard ratio of reoperation among highly exposed men, not even highly exposed men who return to work early,” reported investigators Marie Vestergaard Vad, MD, and her colleagues in the Department of Occupational Medicine,

SAN FRANCISCO—With the risk for death from bariatric surgery now as low as that for knee replacement surgery, the bariatric surgery community has set its sights on a new goal: reducing readmissions after bariatric surgery.

“Our next horizon is targeting readmissions, specifically, reducing readmissions within 30 days by 20% nationally,” said John Morton, MD, president of the American Society for Metabolic and Bariatric Surgery and director of bariatric surgery, Stanford University School of Medicine, in Stanford, Calif.

In a presentation at the 2014 Clinical Congress of the American College of Surgeons (ACS), Dr. Morton reported that one in every 20 patients who undergo bariatric surgery in the United States will be readmitted to hospital within 30 days, according to an analysis of 18,296 primary bariatric procedures performed in 2012 and reported to ACS’s National Surgical Quality Improvement Program.

The analysis revealed several key risk factors associated with readmission.

Many of these factors are things that bariatric surgical teams can address pre- and postoperatively, Dr. Morton said.

“We can decrease readmissions with a lot of commonsense things that can be done at the right time for the right patient,” he said. Recommendations include dietary counseling about food and water intake and having patients

see HEAVY LIFTING page 22

see READMISSIONS page 16

Dear Surgeons Around the World,

I

t is with pride, pleasure and not a little apprehension that I announce that the 1st World Conference on Abdominal Wall Hernia Surgery will take place in Milan, Italy, this April. On Saturday, April 25, at 14.45, things get underway!

This unique event will see the participation of the three-year joint congress of the European Hernia Society and the Americas Hernia Society, as well as the annual congresses of the Asia-Pacific Hernia Society, the Australasian Hernia Society and the Afro Middle East Hernia Society.

This will be the first, but I’m sure not the last, such meeting, as the interest for a regular international federated congress is very high. The uniqueness of this event stems not only from the fact that many of the top experts from five continents will be gathered under the same roof, but also the fact that this will be the only congress of its kind in 2015.

We have received more than 1,200 papers from all over the world, demonstrating the great interest in this field and the desire of surgeons to participate in such an event. I must admit that it was not an easy task creating the scientific program, but I had much help see HERNIA MEETING page 22

Experienced Robotic Surgeon Offers Thoughts

tell us about your experience?

Dr. Zureikat: I started using the robot in 2010, after training in both laparoscopic and robotic surgical oncology. Although I use standard see ROBOTICS page 20

Heavy Lifting May Not Put Patients At Risk for Hernia Reoperation B Y C HRISTINA F RANGOU

P

atients who return to jobs involving heavy lifting or extended periods of walking or standing after inguinal hernia repair do not appear to be at a higher risk for reoperation, according to a study of more than 34,000 Danish men who underwent inguinal hernia repair between 1998 and 2008.

INSIDE In the News

On the Spot

Surgeons’ Lounge

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New Mesh Technique May Avoid Unwanted Fixation in Inguinal Hernias

CONVENTION ISSUE: 1STT World Conference on Abdominal Wall Hernia Surgery

Colleen Hutchinson Poses Controversial Questions on Colorectal Cancer Treatment to World Experts

The Robotic Repair of Ventral Hernias

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

New Mesh Technique May Avoid Unwanted Fixation in Inguinal Hernias B Y C HRISTINA F RANGOU

S

panish surgeons have proposed a new technique for using self-gripping mesh in inguinal hernia repair that may reduce problems of accidental fixation to undesired structures during surgery.

In a report published online in Hernia, J.L. Porrero, MD, and colleagues at the Universitario Santa Cristina in Madrid described a technique in which they fold the upper third of the mesh over the center third, hiding the microgrips that make the mesh sticky [Dec. 6, 2014. Epub ahead of print].

“This means that only the lower third of the mesh has the microgrips exposed, so it can be easily fixed to the pubic bone and inguinal ligament without undesired fixation to other structures,” they reported.

Self-gripping meshes were developed to prevent need for additional fixation during inguinal hernia repairs, thereby reducing postoperative pain without

need for mesh migration. Three-month results from a randomized controlled, multicenter, international clinical trial that compared a sutureless self-gripping mesh to lightweight polypropylene mesh in a traditional Lichtenstein repair showed that surgery duration, early postoperative pain and infection rates were significantly reduced with the self-gripping polyester (Hernia 2012;16:287-294). Longer-term results from that trial have not been reported.

A more recent meta-analysis found that self-gripping mesh was associated with a shorter operating time but no substantial improvement in pain (chronic or acute) or other complications ((Ann Surgg 2014;259:1080-1085).

Some surgeons have noted that selfgripping mesh can be difficult to maneuver because it can adhere to undesired structures during positioning.

To avoid this problem, Dr. Porrero and colleagues make a small split between the lower and medium third of the mesh to mark the intended split for the spermatic cord. Using this mark, the

upper third of the mesh is folded over the medium third, hiding the microgrips for all but the lower part of the mesh. This way, the mesh can be fixed to the pubic bone and inguinal ligament without sticking to undesired structures.

Once the lower third of the mesh is in place, the split for the spermatic cord is completed and the upper portion of the mesh is passed below the spermatic cord. Finally, the mesh is unfolded to expose the microgrips, and the medium and upper thirds of the mesh are descended to the final position.

Senior author Oscar Cano-Valderrama, MD, a general and digestive surgeon at the Universitario Santa Cristina, said his team has used the technique in 15 patients to date and that it is an applicable approach for any patient undergoing inguinal hernia repair with a self-gripping mesh.

He said he expects patients to experience less pain with this type of mesh because no sutures are used to fix the mesh. “Nevertheless, long-term results after the use of self-gripping mesh repair

Michael Goldfarb, MD

Frederick L. Greene, MD

Long Branch, NJ

Charlotte, NC

Leo A. Gordon, MD

Editorial Advisory Board Maurice E. Arregui, MD Indianapolis, IN

Kay Ball, RN, CNOR, FAAN Lewis Center, OH

Philip S. Barie, MD, MBA New York, NY

L.D. Britt, MD, MPH Norfolk, VA

David Earle, MD Springfield, MA

James Forrest Calland, MD Philadelphia, PA

Edward Felix, MD Fresno, CA

Los Angeles, CA

Gary Hoffman, MD Los Angeles, CA

Namir Katkhouda, MD Los Angeles, CA

Jarrod Kaufman, MD Freehold, NJ

Michael Kavic, MD

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Barry A. Salky, MD New York, NY

Paul Alan Wetter, MD Miami, FL

Peter K. Kim, MD

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Kevin Horty Group Publication Editor khorty@mcmahonmed.com

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Raymond J. Lanzafame, MD, MBA Rochester, NY

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Robert J. Fitzgibbons Jr., MD

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Dr. Jacob provides consulting services for Covidien. Drs. Cano-Valderrama and Porrero had no financial interests to disclose.

J. Barry McKernan, MD Joseph B. Petelin, MD

Senior Medical Adviser

are lacking and we need them before this kind of mesh is broadly used.”

Brian Jacob, MD, a hernia surgeon at the Laparoscopic Surgical Center of New York in New York City, who has studied self-gripping mesh use during laparoscopic total extraperitoneal inguinal hernia repair, said he has not had problems with the mesh sticking to unintended structures. Surgeons can use self-gripping mesh “in the creative and individualized manner” they want and patients should experience less pain because of the reduced need for fixation, he said.

“Patients have a fast recovery and we don’t have to worry as much about mesh migration, and we’re putting in less permanent fixation material. Still, only time will tell if there’s a true benefit in reduction of chronic pain and recurrence rates.”

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

Enhanced Recovery Program for Hernias Yields Improvements Improved Pain Control, Intestinal Recovery in Complex Cases B Y C HRISTINA F RANGOU

A

n enhanced recovery after surgery (ERAS) program improved patient outcomes after abdominal wall reconstruction at one of the country’s largest hernia centers, according to a pilot study.

Although prospective evaluations of the ERAS pathway are still needed, “we believe ours or similar ERAS pathways will soon become standard for the vast majority of patients undergoing abdominal wall surgery,” said Yuri W. Novitsky, MD, director of the Case Comprehensive Hernia Center at Case Western Reserve University, Cleveland, and his colleagues in their report, published in the journal Plastic and Reconstructive Surgery (2014;134:151S-159S).

ERAS programs are designed to reduce patient morbidity and hospital length of stay (LOS) after surgery by providing optimal pain management and accelerating patients’ intestinal recovery. ERAS have been shown to significantly shorten LOS after colorectal surgery, for which they were first implemented, as well as in a growing number of general surgical procedures.

This is the first time that ERAS have been reported in abdominal wall reconstruction.

In a pilot study of 42 consecutive patients undergoing open incisional hernia repair requiring myofascial release in a clean surgical field compared with historical controls, implementation of the ERAS pathway resulted in a faster return to tolerance of solid food and passage of stool by 1.4 days (5 vs. 3.6; P<0.0001) and a mean reduction in LOS by 1.4 days (5.8 vs. 4.4; P<0.0001). Since the ERAS program was started, 97% of patients have remained on the pathway.

Dr. Novitsky said the pathway was designed to achieve two goals: optimal pain management and accelerated intestinal recovery. The team provided multimodal pain control with an emphasis on reduced

opiate use and application of a precise intraoperative nerve block with longer-acting local anesthetic, bupivacaine liposome (Exparel, Pacira). Accelerated intestinal recovery was achieved through use of oral µ-opioid receptor antagonist alvimopan (Entereg, Cubist), early feeding and judicious IV fluid administration.

Dr. Novitsky said the team developed the ERAS based on work done by colleagues in the Colorectal Surgery Department of Case Western Reserve University, who pioneered the use of ERAS. They adopted the validated colorectal ERAS to make it applicable to abdominal wall reconstruction.

‘We see a large portion of patients benefit greatly from this approach.

It’s very impressive to see somebody wake up from an operation in little or no pain.’

—Bruce Ramshaw, MD “The process does have challenges,” Dr. Novitsky said, in an interview. “For surgeons, it’s a bit of a leap of faith. All surgeons have individual quirky things and that has to be worked out. You make changes that go against what you used to do.”

But, he added, “having the pathway has made it better and easier for everyone involved.”

In an accompanying editorial, Bruce Ramshaw, MD, chairman of the Halifax Health general surgery residency program and co-director of Advanced Hernia Solutions, Daytona Beach, Fla., said that the authors should be lauded for their practical approach to “real-world clinical quality improvement.

“To consider a more complex set of solutions beyond opioid agonists and strive to make a major abdominal operation relatively pain-free and with minimal effects on bowel function is a very patient-centered goal,” he said, noting that multimodal approaches to pain is a growing trend in hernia surgery.

“We see a large portion of patients benefit greatly from this approach. It’s very impressive to see somebody wake up from an operation in little or no pain,” he said.

Both multimodal pain control and ERAS require more study, he cautioned. In this report, the authors did not present important details on costs of care and long-term outcomes. “What about hernia recurrence, chronic pain incidence and other long-term complications? What about the overall costs of care for this care process, including these long-term issues?”

The ERAS pathway calls for an intraoperative transversus abdominis plane block with bupivacaine liposome injection (20 mL diluted to 120 mL), followed by hydromorphone patient-controlled analgesia at 0.2 mg every six minutes as needed and a 1 g dose of IV acetaminophen (Ofirmev, Mallinckrodt Pharmaceuticals) every six hours for 48 hours, with oral oxycodone 5 to 10 mg every four hours as needed for breakthrough pain. Patients receive oral gabapentin 300 mg three times a day as soon as they can tolerate oral intake, which is continued until discharge.

The authors also recommend gabapentin in patients with incisional pain lasting beyond 30 days, especially for pain related to lateral dissection or fixation sutures in the lateral abdominal course.

Nonsteroidal anti-inflammatory drugs are not given routinely due to the risk for postoperative acute kidney injury.

Patients receive ice chips and sips of water after surgery, followed by limited clear liquids on postoperative day (POD) 1, unlimited clear liquids on POD 2 and a regular diet on POD 3.

Since the publication, the investigators have made some adjustments to the pathway, including dropping diazepam from pain management and further accelerating patients’ return to a regular diet, said Dr. Novitsky.

Updated details on the ERAS program will be presented in April at the 1st World Conference on Abdominal Wall Hernia Surgery.

Primary Tumor Resection in Colorectal Cancer May Be Overused B Y C HRISTINA F RANGOU

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rimary tumor resection may be performed too frequently for patients with advanced colorectal cancer (CRC) in the United States, according to a new study.

According to a report published online in JAMA Surgery, patients with stage IV CRC are undergoing primary tumor resection (PTR) less often since 1998, with a marked drop-off after 2001 as new chemotherapeutic and biologic agents became available ((JAMA Surgg 2015 [Epub ahead of print]).

By 2010, the last year of data analyzed, 57.4% of patients underwent PTR, down from 74.5% in 1988, the study found.

However, the investigators said that despite the decrease, those figures indicate many patients may be undergoing surgery for CRC needlessly.

“It appears that current treatment practice may still

lag behind evidence-based treatment guidelines and that there is still work needed to translate evidence on the effectiveness of health care decisions into clinical practice,” reported Chung-Yuan Hu, MPH, PhD, and colleagues at the University of Texas MD Anderson Cancer Center, Houston.

Current National Comprehensive Cancer Network guidelines recommend systemic chemotherapy without PTR in patients presenting with non-obstructive unresectable stage IV disease. However, questions persist about the potential benefits and harms of PTR in the absence of symptoms. Many physicians and patients are concerned that patients whose primary tumors are asymptomatic may develop symptoms such as obstruction and bleeding on chemotherapy, said senior author George Chang, MD, associate professor, Surgical Oncology and Health Services Research, at MD Anderson, in a statement.

“We know from a previous Phase II, cooperative

group study that it’s safe to give chemotherapy even with biologics to patients with metastatic disease. Yet, there’s still controversy about the role of primary tumor resection because some believe there’s a survival association.”

The study was designed to evaluate use of PTR in patients with metastatic CRC in everyday practice and nationally by examining trends in the proportion of metastatic-disease patients undergoing PTR. For the retrospective, population-based study, Dr. Chang and his colleagues used the National Cancer Institute’s (NCI) Surveillance, Epidemiology, and End Results (SEER) program database to identify 64,157 patients, all of whom were diagnosed with metastatic colon or rectal cancer between Jan. 1, 1988 and Dec. 31, 2013.

Overall, 67.4% of patients underwent PTR, with those receiving the surgery more likely to be female, younger than 50 years old, married, and to have colon cancer and a high-grade tumor. Independent

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

Study Finds Limited Role for Analgesic Pumps in Lap Sleeve Gastrectomy Benefits in Open Procedures Not Shared by Laparoscopic Cases B Y K ATE O’R OURKE BOSTON—A double-blind, randomized controlled trial has concluded that in patients undergoing laparoscopic sleeve gastrectomy, a continuous infusion of local anesthetic via an anterior abdominal wall catheter does not improve pain control and does not reduce the use of narcotics, the use of antiemetics or hospital length of stay (LOS).

“Our study does not support the increased cost of using the continuous infusion [analgesic] catheters,” said Elaine Cleveland, MD, a general surgeon at William Beaumont Army Medical Center, in El Paso, Texas. She presented the study at Obesity Week 2014 (abstract A102).

The proposed benefits of continuous analgesic infusion catheters include better pain control in the perioperative setting, which can reduce the use of narcotics and their associated side effects. “This can lead to a more comfortable recovery with faster return to normal activity, decreased length of stay and possibly decreased costs,” Dr. Cleveland said.

These benefits have been shown in several studies. In a randomized, placebocontrolled study involving 70 patients, a continuous analgesia infusion pump of 0.5% bupivacaine after midline laparotomy reduced average daily patient-controlled analgesia (PCA) morphine by 25 mg (33.7 vs. 60 mg; P P=0.03) (J Am Coll Surgg 2006;202:297-305). In a 21-patient, placebo-controlled study, continuous administration of 0.2% ropivacaine

for 48 hours after open colorectal resection for cancer reduced average daily morphine by 36 mg and decreased LOS, pain scores and antiemetic use ((Anesthesiologyy 2007;107:461-468).

Studies evaluating the use of these pumps in laparoscopic procedures, however, have provided mixed results, and to date, no studies have evaluated their use in laparoscopic surgery. To fill this knowledge gap, surgeons at William Beaumont Army Medical Center randomized patients undergoing laparoscopic sleeve gastrectomy to receive either 0.2% ropivacaine or 0.9% normal saline via an intraoperatively placed continuous pain catheter. Dr. Cleveland said the pumps cost $710 and are placed either in the preperitoneal space or in subcutaneous tissue.

Postoperatively, catheter rates were set at 7 mL per hour and patients received PCA with hydromorphone plus IV antiemetics. On the morning of postoperative day 1, patients were started on oral nausea and pain medications, and the catheter infusion rates were decreased to 4 mL per hour. Patients were discharged when they were ambulatory and oral medications could control their pain and nausea.

After discharge, clinicians recorded total narcotic use, total antiemetic use, pain scores, LOS and adverse events.

To be enrolled in the study, patients were required to have a body mass index (BMI) greater than 40 kg/m2 or a BMI greater than 35 with comorbidities.

Patients were excluded if they had revision surgery, single-port surgery or an allergy to local anesthetic. Only 7% of patients in the study were male; the average age was about 35 years. The study was halted early after an interim analysis showed that an additional 20 patients would not change the outcomes.

The investigators identified no benefit of catheter use. “The continuousinfusion catheter provided no benefit regarding narcotic usage, pain scores, PCA attempts, antiemetic usage or hospital stay in the setting of laparoscopic sleeve gastrectomy,” Dr. Cleveland said (Table). Adverse events were minimal, with no hypoxia or ileus in either group; urinary retention was identified in three patients, two in the ropivacaine group.

Dr. Cleveland said the study was limited in that it was performed at a single institution and most of the patients were young females, which may not represent

the typical bariatric population.

So, why are analgesia pumps beneficial in open but not laparoscopic procedures?

“In open surgeries, the catheters are placed directly in the incision, delivering local anesthetic into the operative site. In laparoscopic surgeries, the catheters are placed near the incisions, but may not directly deliver anesthetic to these small trocar sites,” Dr. Cleveland said. “Additionally, open surgeries tend to have increased pain compared to laparoscopic surgeries, and with that, local anesthetic can have a greater impact in reducing pain.”

Kelvin Higa, MD, director of minimally invasive and bariatric surgery, Fresno Heart and Surgical Hospital, in Fresno, Calif., said the study was important in an era when emphasis is placed on value-based care.

“Today, the environment in which we practice is changing. As surgeons, we were only taught to think about quality at any cost, and now we are charged with talking about value … and cost-effectiveness. This research is something that any of us can do on a local level and can make a significant impact on the care of our patients.”

Table. Comparison of Outcomes Between Patients Receiving Ropivacaine and Placebo Ropivacaine

Placebo

P Value

Total narcotic, morphine equivalents

51.8

55.17

0.63

Patient-controlled analgesia attempts

61.95

73.74

0.59

Ondansetron, mg

10.6

10.6

0.98

Promethazine, mg

11.7

6.83

0.10

Hospital time, h

37.45

38.19

0.77

of receiving PTR, the researchers also found that the median relative survival rate of metastatic colon cancer patients improved from 8.6% in 1988 to 17.8% in 2009.

Dr. Chang said he hopes the findings might help patients and physicians make decisions about the need for PTR in the metastatic setting.

Experts who were not involved with the study agreed that PTR “may” be overused in the United States, but highlighted the need for more research.

“I agree with the conclusion that we probably do overuse primary tumor resection in someone who is nonsymptomatic from their cancer and has really truly unresectable disease,” said Christopher Mantyh, MD, chief of colorectal surgery at Duke University Medical Center, Durham, N.C., who was not involved with the study.

He said the study’s strength and its weakness is that the conclusions are based on analysis of the SEER database. “Obviously, it’s a huge database, but it only represents 20% of patients in the country, so clearly there can be a selection bias.”

Moreover, SEER does not include important details

‘I agree with the conclusion that we probably do overuse primary tumor resection in someone who is nonsymptomatic from their cancer and has really truly unresectable disease.’

—Christopher Mantyh, MD

on issues such as individual patient factors and institutional factors that can affect the decision to use or not to use PTR, Dr. Mantyh noted.

“The issue is more complicated than just knowing how many patients undergo PTR,” said Steve Sentovich, MD, MBA, clinical professor and chief of colon and rectal surgery at City of Hope Hospital in Duarte, Calif. “As the authors admit in their discussion, they don’t know if the PTR was done for palliation (as indicated by current guidelines) or with a resection of a

metastasis (also indicated by current guidelines).”

The study did not directly compare survival between patients who received and did not receive PTR, as SEER data make such evaluation impossible without significant risk for bias. The researchers also lacked information about systemic chemotherapy.

A large randomized trial is currently underway in Europe that will examine the issue of PTR and survival. It is not known when results from this trial will be available.

Beyond the current primary indication for PTR, Dr. Chang said there may be a group of patients for whom PTR may be beneficial because it may allow them to continue to receive chemotherapy. In the general population of metastatic CRC patients for whom resection cannot be performed, PTR can result in unanticipated delays or inability to receive systemic therapies.

The study was supported, in part, by grants from the National Institutes of Health/NCI, T32CA009599 and K07-CA133187 and a career development award from the American Society of Clinical Oncology Foundation.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

Ultrasound Finds Cancers Missed by Mammogram in Dense Breasts she pointed out that it is easier and less costly to treat a cancer if it is detected at an early stage, noting that in patients who returned for an ultrasound in a subsequent year, the cancers detected were extremely small, typically less than 1 cm.

A recent study estimated that supplemental ultrasonography screening for women with extremely dense breasts would cost $246,000 per quality-adjusted life-year gained (Ann ( Intern Med 2014 Dec 9. [Epub ahead of print]). This is well above $50,000, often touted as a reasonable threshold for cost-effective care (N Engl J Med 2014;371:796-797).

Dr. Lipson, who served as the discussant of the Connecticut study, pointed out that most of the PPV improvement in Dr. Weigert’s study was due to a shift of patients from a recommendation for biopsy to a recommendation for short-term followup, and this could be seen as a benefit or harm. “It’s not that the patient is returned to annual screening. She is kind of sucked into a vortex of shortterm follow-up,” said Dr. Lipson.

Dr. Lipson also noted that none of the breast cancer ultrasound studies conducted so far have used a control group, and none have long-term follow-up. “The true clinical impact

B Y K ATE O'R OURKE SAN ANTONIO—Results from a Connecticut study have some clinicians proclaiming that all women with dense breasts who have a negative mammogram should be offered an ultrasound.

The study, presented at the 2014 San Antonio Breast Cancer Symposium (SABCS; abstract S5-01), found that ultrasound identified an additional 3.2 cancers per 1,000 women.

“It is time to think of a new paradigm of utilizing screening ultrasound,” said the lead author of the study Jean Weigert, MD, a radiologist and director of Breast Imaging at the Hospital of Central Connecticut, in New Britain.

Since October 2009, Connecticut law has required clinicians to use certain language when providing mammographic results to women with dense breasts (approximately 40%-50% of women). Clinicians are required to say, “Your mammogram demonstrates that you have dense breast tissue, which could hide small abnormalities, and you might benefit from supplementary screening tests, which can include a breast ultrasound screening or a breast [magnetic resonance imaging] examination, or both, depending on your individual risk factors.”

Connecticut is one of 19 states, to date, that mandate that clinicians include information on breast density when providing mammogram results to patients, according to Jafi Lipson, MD, assistant professor of radiology at Stanford University Medical Center, in Palo Alto, Calif. Additionally, Dr. Lipson said, “Insurance coverage for supplemental tests is now mandated [for patients with dense breasts] in four states, and there is federal legislation pending at this point.”

This flurry of legislation was spurred, in part, by a multicenter 3,000-patient study that demonstrated that adding a single, bilateral screening ultrasound to mammography detected an additional 4.2 cancers per 1,000 in women with dense breast tissue and a family history or prior history of breast cancer ((JAMA 2008;299:2151-2163). This almost doubled the number of cancers found by mammography alone.

In the new study, researchers evaluated the effect of the new Connecticut law at two radiology practices with multiple sites in the state during the first four years after the legislation was enacted. Overall, 30% of women with dense breasts and a negative mammogram chose to have an ultrasound, and this rate was steady over the four years.

‘The true clinical impact of finding these additional cancers is really unknown.’

—Jafi Lipson, MD

Table. Positive Predictive Value of Ultrasound in Connecticut Practices Studied

Year

PPV of Ultrasound, %

Screening Mammogram

Screening Ultrasound

BIRADS 1 or 2

BIRADS 3

BIRADS 4 or 5

Positive Biopsy

1

7.1

30,679

2,706

2,377

174

151

11

2

6.1

32,500

3,351

3,000

168

180

11

3

8.1

32,230

4,128

3,819

168

148

13

4

17.2

27,937

3,331

2,889

358

53

11

BIRADS, Breast Imaging Reporting and Data System; BIRADS 1, negative; BIRADS 2, benign; BIRADS 3, probably benign; BIRADS 4, suspicious abnormality; BIRADS 5,, highly suggestive malign malignancy; nancy; PPV, positive predict predictive tive value

“This may be due to lack of education and insurance issues,” said Dr. Weigert, who thought the rate should have been higher. “There are many high-deductible plans, and women do not want to pay for the test.”

The positive predictive value (PPV) of ultrasound improved over time, indicating that, as expected, there was a learning curve in determining which identified lesions needed to be followed and which needed to be biopsied (Table). By year 4, the PPV was 17.2%, with 3.2 additional cancers detected per 1,000 women. “The first three years, we

were still doing a significant number of biopsies on patients with findings that we didn’t know whether they were positive or negative, but in the fourth year, there was a significant [improvement],” said Dr. Weigert.

The cancers detected were of all histologic grades but predominantly grade 2 and 3, hormone-positive and nodenegative. Very few patients had risk factors other than dense breast tissue.

Cancers were detected in patients who were in their mid-40s to mid-70s.

Although the study was limited in that it did not include a cost analysis,

of finding these additional cancers is really unknown,” Dr. Lipson said.

“Specifically,” she added, “would these additional cancers otherwise be detected at the next mammography screen while still small, node-negative and at the early stage, and does the detection of these early cancers have an impact on mortality?”

Dr. Weigert disclosed being on the advisory board for Tractus. Dr. Lipson reported no relevant financial relationships.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

Fecal Microbiota Transplants: An Insider’s Guide B Y M ONICA J. S MITH NEW YORK K—Need a blender? Lawrence J. Brandt, MD, a contemporary pioneer and proponent of fecal microbiota transplant (FMT) has a surplus, brought in by patients about to undergo the somewhat radical but overwhelmingly successful treatment for recurrent Clostridium difficilee infection (CDI).

“They never want the blender back,” said Dr. Brandt, professor of medicine and surgery at Albert Einstein College of Medicine and emeritus chief of the Division of Gastroenterology, at Montefiore Medical Center, in New York City.

Interest in FMT has ramped up considerably in the past few years, but the concept dates to fourth-century China, when doctors administered a fecal suspension by mouth for food poisoning or severe diarrhea. “By the 16th century, there was a menu of ways to take stool, and it was given for a variety of disorders: diarrhea, pain, vomiting, constipation,” Dr. Brandt said.

Contemporary use of FMT dates to 1958, when it was administered by enema to treat four patients with pseudomembranous colitis. It was first used to treat CDI in 1983, and in 2013 the American College of Gastroenterology included consideration of FMT in its guidelines as a treatment for recurrent CDI. “The rationale is that we can avoid another course of the anti-C. difficile antibiotics that, for example, in the case of vancomycin, is really maintaining the condition for which you were given it in the first place: a disturbance in the microbiota, or dysbiosis,” Dr. Brandt said, “FMT can immediately re-establish the normal diversity of the intestinal microbiome and thus restore the ability of the microbiota to resist colonization.”

How It’s Done The first step is choosing a donor, who can be any healthy person. “Whether you’re dealing with a spouse or family member, household contact or total stranger, the results are basically the same, raising the whole concept of a universal donor,” Dr. Brandt said. “People don’t seem to have much difficulty accepting stool from someone they know or don’t know if they’re sick enough, and these people are sick enough.”

The next step is thorough screening.

Donor stool is tested for parasites, C. difficile, giardia, cryptosporidium, isospora and norovirus; the donor also is tested for syphilis; hepatitis A, B and C; HIV infection; and other blood-borne infections.

Some donor exclusions include recent

use of antibiotics, diarrhea, constipation, inflammatory bowel disease, colorectal cancer, immunocompromise, use of anticancer drugs, high-risk sexual behaviors and recent body piercing or tattoos.

Other exclusions include diabetes, obesity, atherosclerotic cardiovascular disease and mood and neurologic disorders.

Preparation for the recipient includes discontinuing anti-C. difficile antibiotics two to three days before the procedure, and undergoing a large-volume

’They never want the blender back.’

—Lawrence J. Brandt, MD colonoscopy bowel preparation the evening before.

“I give them some loperamide righ ht before I put the stool in so that theyy hold it for at least four, preferably sixx hours,” Dr. Brandt said. “I sometimes

givve the donor a gentle laxaative the night before. I like to use stool that’s fresh, passed within six hours—it does not need to be refrigerated.”

Dr. Brandt suspends the stool in non-bacteriostatic salline and filters it through gauzze into a canister; it can be mixxed by hand or by blender. see MICROBIOTA page 23

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On the

{Spot}

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

With Colleen Hutchinson Colorectal 2015:

Dueling Debates in Colorectal Surgery A

Participants Conor Delaney, MD, PhD, is chief of colorectal surgery and surgical director of the Digestive Health Institute at University Hospitals Case Medical Center, Cleveland.

s I have done for my past On the Spott columns that focus on colorectal surgery, this year I enlisted the help of Steven Wexner, MD, to identify the most legitimately debatable topics in this arena and the best-qualified voices to weigh in on them. This On the Spott is also once again a dueling debates in colorectal surgery, where each contributor weighs in on only one topic rather than

Statement: Transanal total mesorectal Jonanthan Efron, MD, is interim director, Department of Surgery, associate professor of surgery and urology, and Mark M. Ravitch MD endowed professorship of surgery, Johns Hopkins University, Baltimore.

Abe Fingerhut, MD, FACS, FRCPS (g), FRCS (Ed), (Hon c.), is professor of surgery, University of Graz, Graz, Austria.

Stephen R. Gorfine, MD, FACS, FASCRS, FACP, is clinical professor of surgery at the Icahn School of Medicine at Mount Sinai, and attending surgeon, Division of Colon and Rectal Surgery, Mount Sinai Hospital, New York City.

Antonio Lacy, MD, is chief, Gastrointestinal Surgery Department, Hospital Clinic, and professor of surgery, University of Barcelona School of Medicine, Barcelona, Spain.

Jorge Lagares-Garcia, MD, is chair, Division of Colon and Rectal Surgery, Roper Hospital, Charleston, South Carolina.

Disclosure: Dr. Lagares-Garcia is instructor and consultant for Intuitive Surgical, Sunnyvale, Calif.

Feza H. Remzi, MD, is chairman, Department of Colorectal Surgery at Cleveland Clinic, in Ohio.

Steven Wexner, MD, is director of the Digestive Disease Center and chairman of the Department of Colorectal Surgery, Cleveland Clinic Florida, Weston.

Disclosure: Dr. Wexner reported stock options from past consulting with Intuitive Surgical, Sunnyvale, Calif.; and consulting fees, laparoscopy; inventor’s income, transanal endosurgery from Karl Storz.

Oded Zmora, MD, is associate professor of surgery; director, Colon and Rectal Surgery; vice chair, Department of Surgery, Sheba Medical Center, Tel Aviv, Israel.

excision (TaTME) for rectal cancer offers superior oncologic outcomes as compared to standard transabdominal TME.

Conor Delaney, MD: Disagree.

TaTME is an interesting new extension of an old technique, but there are as yet no data supporting superior oncologic outcomes. Remember, intersphincteric resection has been around for a long time for the tumors within 1 cm of the dentate line, and many surgeons do a transanal mobilization of the distal rectum for lower-third rectal tumors, especially when approached laparoscopically. These appear to be equivalent to a standard transabdominal approach (whether open or laparoscopic).

In fact, in a systematic review we recently published in Surgical Endoscopy, 11.8% of TaTME circumferential margins were positive, and pneumo-retroperitoneum, air embolism and urethral injury had been reported, despite TaTME generally being done to date by very experienced surgeons. Although TaTME may help reduce the conversion rate for laparoscopic surgery for low rectal tumors in obese males, we must be careful that we do not trade this for worse oncologic outcomes and higher complication and injury rates.

TaTME is likely to be oncologically equivalent, and must be evaluated to make sure it is so, but we need more data before saying it is better.

Antonio Lacy, MD: Agree.

Recently, some studies have shown the feasibility of TaTME, and some comparative studies have been published showing that it is not inferior to standard transabdominal TME in terms of short-term outcomes. These outcomes also stand for surgical-related aspects that may have future impact on disease recurrence, such as better measure of distance from the anal verge or circumferential resection margin (CRM). And last year, a randomized study concluded that, for low rectal cancer, TaTME reduced the risk for positivity of that margin. And what to say about differences in distal margin!

Nowadays, everybody looks forward to oncologic long-term outcomes. We all know that randomized controlled trials are warranted; however, existing data seem to be promising, suggesting a tendency to improve disease-free survival after TaTME. These questions will be answered in the

all contributors weighing in on all statements.

With a special thanks to Dr. Wexner for lending his expertise and thoughts on each topic, I present some of the most current debates in colorectal surgery. Read on, take a side, access On the Spot online and share your view with a comment.

Thanks for reading!

—Colleen Hutchinson

near future, but as an experienced rectal surgeon, I strongly believe that a quality surgery may offer superior long-term oncologic outcomes.

Dr. Wexnerr weighs in: TaTME is a very promising new technology that seems to result in equivalent—and may, in fact, ultimately be proven to offer superior—oncologic outcomes to transabdominal TME. Moreover, part of the tremendous appeal of TaTME is the ability to avoid the expense of the robotic platform to “facilitate” the distal pelvic dissection. Virtually every study during the past nearly 25 years has shown numerous significant shortterm benefits comparing laparoscopic to open TME relative to pain, length of hospitalization, length of cosmetic outcomes, length of ileus and other variables. Additionally, a myriad of authors have demonstrated oncologic superiority relative to lymph node harvest and/or tumor-free margins.

Although robotic TME has failed to confer any proven advantage as compared with laparoscopic TME, many individuals market this approach as a way to flatten, shorten or eliminate the learning curve to transition from open to minimally invasive transabdominal TME. TaTME is appealing in that it offers the possibility to eliminate the costly cumbersome robotic platform while conveying equivalent or perhaps even superior oncologic outcomes. Therefore, although TaTME has not yet been proven to offer superior oncologic outcomes compared with standard transabdominal TME, it does certainly offer promise in this direction.

Statement: Bowel preparation is mandatory for elective colorectal surgery.

Abe Fingerhut, MD and Hester Cheung, MD: Agree.

Mechanical bowel preparation (MBP) before elective colorectal surgery—a time-honored dogma—is thought to decrease the intraluminal fecal mass and, presumably, also the bacterial load in the bowel, in turn reducing the postoperative infectious complication rate (including anastomotic leakage and surgical site infection). Challenged by trauma surgeons when primary repair of colonic injury provided good results (Br J Surg 2007;94:689-695) several studies have since contested this idea; one of the most recent systemic

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

reviews and meta-analysis does not support the routine use of MBP before colonic cancer surgery in terms of reduction of infectious postoperative complications (Lancett 2007;370:2112-2117). However, the impact of MBP is still unclear in rectal surgery because many studies in the literature excluded rectal surgery, and only one French multicenter randomized trial has demonstrated that rectal surgery without MBP is associated with higher risk for overall and infectious morbidity rates, suggesting continuing to perform MBP before elective rectal resection (Cochrane Database Syst Rev v 2011:CD001544).

Because laparoscopy may pose specific difficulties in localization of small, nonpalpable lesions without serosal surface landmarks, bowel preparation should still be considered because of the need for intraoperative colonoscopy in this setting.

In conclusion, there is no strong evidence suggesting the routine use of MBP for elective colonic resection. However, preoperative MBP may be recommended in selected patients with intraperitoneal rectal and/or small colorectal cancer in whom intraoperative colonoscopy might prove necessary for localization. This is especially important for patients undergoing laparoscopic surgery, where the surgeonâ&#x20AC;&#x2122;s ability to palpate the colon is limited.

Oded Zmora, MD: Strongly disagree.

Numerous randomized prospective studies, including two large multicenter randomized prospective trials (one in Sweden with 1,343 patients and one from the Netherlands with 1,260 patients) and a meta-analysis, all showed no advantage to MBP in terms of anastomotic leak, surgical site infection and postoperative complications. Scientific data are strong enough to support the omission of the routine use of MBP in elective colorectal surgery. It is time for a well-designed and well-performed North American study to convince most American surgeons, also.

Special considerations that may selectively require MBP include small tumors that may need intraoperative endoscopy for tumor localization, and perhaps rectal surgery. A single French randomized trial suggested a higher complication rate without preparation specifically in rectal surgery. These results should be reassessed in further studies. An interesting study was recently published by the Swedish multicenter group, suggesting that no bowel preparation may be associated with higher rate of cancer recurrence (Br J Surg 2014;101:1594-1600). The mechanism for this possible phenomenon, however, is poorly understood, and this should be further investigated in future studies.

Dr. Wexnerr weighs in: The main reason to perform bowel preparation for elective colorectal surgery is to facilitate bowel manipulation

and intraoperative endoscopy. We have clearly demonstrated a lower incidence of postoperative anastomotic problems when routine intraoperative endoscopy is performed to assess pelvic anastomoses than when it is only selectively employed.

Additionally, it may be necessary to perform endoscopy to visualize lesions, ink marks and bowel mucosa. Therefore, although routine MBP does not seem to be required for its originally stated purpose (to decrease or avoid surgical site infection), it has become a very useful adjunct to allow intraoperative endoscopic visualization, particularly during

laparoscopic procedures. Also, the minimally invasive instrument manipulation of a fecally loaded colon seems less safe than is the handling of an empty colon.

Statement: Routine one-stage (as opposed to two-stage) restorative proctocolectomy is recommended.

Feza Remzi, MD: Disagree.

I do believe patients who undergo restorative proctocolectomy (RPC) have the best outcome when all goes well at the initial surgery. Personally, by

doing a routine one-stage RPC, we are taking an unnecessary risk on behalf of our patients, especially in patients with inflammatory bowel disease (IBD). This was a controversial topic to start with in the prebiologic era. Some did it routinely; some, like our group, did it selectively, depending on the preoperative and intraoperative stringent criteria. We are in the biologic era in which almost no patient with IBD is referred to surgery without the trial of biologics. These drugs are immunosuppressant to start with and there is a trend prolonging the Continued ON page 10

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

jContinued from page 9 treatment with biologics trying to avoid the unavoidable. These result in septic complications, which negatively affect the long-term outcomes.

In my opinion, offering our patients a routine RPC in the biologic era is riskier than before. I do believe, unless it is a familial adenomatous patient who is motivated and fits to stringent criteria we employ, doing a one-stage RPC is an absolute contraindication in the biologic era.

Stephen Gorfine, MD: Disagree.

One-stage RPC can be performed safely for a group of highly selected patients only. “Routine” use of this technique is not recommended. Temporary diversion in the setting of RPC does not prevent pouch or anastomotic leaks, but rather mitigates the consequences should one occur. One-stage RPC offers suitable patients the relative benefits of elimination of the risks, discomfort and costs associated with a second surgery; reduced total hospital time; and complete avoidance of an ileostomy. These benefits must be weighed against the risk for potentially severe septic complications.

Patients suitable for a one-stage RPC are generally taking less than 20 mg of prednisone daily and are not on multiple immunosuppressive medications such as infliximab in combination with cyclosporine and 6-mercaptopurine. Candidates for one-stage surgery are generally not overtly malnourished or “sick” with an acute exacerbation of colitis. Surgery is always performed in the elective setting and must proceed smoothly. The ileal

pouch–anal anastomosis (IPAA) must be completely tension-free. The final decision concerning omission of ileostomy is always made after the pouch and IPAA have been constructed. Using these criteria, we have successfully performed more than 400 one-stage RPCs. Long-term functional results and complication rates are similar among patients undergoing RPC with and without diversion.

Dr. Wexnerr weighs in: Although one-stage pouches can be performed, I disagree that they should be done so routinely. The vast majority of studies and meta-analyses have decided in favor of two-stage J-pouches rather than one-stage J-pouches. Nonetheless, with careful patient selection, meticulous technique and a very well-informed patient, the procedure can, in selected cases, be undertaken. If after a lengthy informed consent, the patient still desires a one-stage procedure and is a medically appropriate candidate (without significant malnutrition, taking less than 20 mg per day of prednisone, remote from any anti–tumor necrosis factor agents, and is not anemic or obese), then the surgeon must rely on the intraoperative decisionmaking algorithm. Only in instances of a “quick and easy” RPC with minimal blood loss and a tension-free anastomosis should avoidance of a temporary ileostomy be contemplated.

Statement: Robotic rectal cancer surgery has multiple proven advantages as compared to the laparoscopic approach.

Jorge Lagares-Garcia, MD: Agree.

Laparoscopic TME has been proven to be safe, with lower morbidity and mortality. Despite that, the operative times and conversion rate are high, especially in patients with narrow pelvis or high body mass index (BMI). The robotic platform offers the surgeon an improved dexterity and vision in the performance of complex pelvic operations like rectal cancer. To date, the largest North American data of robotic rectal cancer recently published by Hellan et al showed comparable operative times than laparoscopic while offering an extremely low positive circumferential margin of 0.9% and 5.9% conversion rate independent of the patient’s BMI in 425 patients ((Ann Surg Oncoll 2014 Dec 9.

[Epub ahead of print]). Local recurrence rate was 1.7%. Although the limitations of this study are clear in its retrospective nature, this large number of high-volume expert robotic surgeons clearly indicates the potential in rectal cancer surgery, although further randomized controlled trials, appropriately powered for each technique, are needed. In our current personal experience of more than 450 cases, in a nonteaching institution with a dedicated team, robotic proctectomy ranges from 120 to 150 minutes (unpublished data), clearly superior times to laparoscopic current series. Although the initial expense and cost is higher per case, the minimal conversion rate and the completion of the TME as a quality indicator in our current series is excellent.

Jonanthan Efron, MD: Disagree.

Although I use the robot for rectal

cancer surgery, there has yet to be any published data to support the statement: “Robotic rectal cancer surgery has multiple proven advantages as compared to the laparoscopic approach.” What I really disagree with in the statement is the word “proven.” I do feel the robot provides the added benefits of superior visualization, increased flexibility and greater ability to retract in the pelvis; those benefits have not been translated into proven advantages over the laparoscopic technique in any published trial. Multiple retrospective reviews have compared robotic to open, and robotic to laparoscopic proctectomy; the only advantage being proven to date is perhaps a lower conversion rate with the robotic technique. To the detriment of the robot, its use clearly increases the length, and the cost of minimally invasive proctectomies. To date, there is no good prospective trial demonstrating any benefit of the robotic technique over the laparoscopic technique. Hopefully, we will see some definitive data to either support or refute this statement in the near future as randomized trials comparing the two techniques are underway and near completion.

For now, I am forced to disagree with the above statement.

Dr. Wexnerr weighs in: Within five years of the advent of laparoscopic colorectal surgery, a myriad of studies had demonstrated superior outcomes for pain, immunosuppression, length of ileus, ability to tolerate oral intake, resumption of bowel activity, hospital discharge, resumption of normal lifestyle, improved cosmesis, decreased

Gut Reaction: Colorectal 2015 State of malpractice insurance in colorectal surgery

“Obamacare”

Best advice to the new medical student who plans to specialize in colorectal surgery

Best advice to the community surgeon who would like to become more involved in colorectal surgery association leadership and general research/publication

The dynamic between oncologist and oncologic surgeon

Dr. Efron

The same as for Making significant the rest of surgery: changes. poor.

Obtain the best training you can; it is the foundation for the future care you deliver.

Research and participation in a national A symbiotic relationship that society is dependent on the person, not their partners to improve patient type of practice; if you enjoy either, you can care. do both.

Dr. Gorfine

Abysmal

Worse than expected.

Great field; work hard and go for it!

Join the ASCRS and participate.

Often harmonious, sometimes testy.

Dr. Lacy

Not qualified to comment on the situation in the United States.

Not qualified to com- Work hard, take care of ment on the situation patients, study, then enjoy. in the United States.

Surgery is essential, but innovation is too.

We work together in the committees and have a close relationship.

Dr. LagaresGarcia

Really adequate?

“Equal access” must Best decision you ever will reflect “equal care.” make.

Join local societies and Web chats in ASCRS.

Needs improvement and a common goal.

Dr. Remzi

It is all over the place.

Let’s be part of the solution.

Best is yet to come; please join Please tell us who you are. us.

We complete each other.

Dr. Zmora

Lose–lose situation.

Thank God I live in Israel.

Go for your dreams!

Multidisciplinary team: a winwin situation

Go for your dreams!

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

adhesions, decreased ventral incisional hernia, decreased morbidity and decreased mortality. Within 10 years of the advent of laparoscopic colorectal surgery for rectal carcinoma, many more studies had already demonstrated either equivalent, or, in some cases, superior oncologic outcomes to laparotomy.

Perhaps the most relevant study for robotics is the recent study by Park et al concluding that robotic rectal cancer surgery failed to confer any oncologic or other benefit [over standard laparoscopy].

In the study by Park et al, 217 patients who underwent minimally invasive surgery for rectal cancer were prospectively enrolled to undergo either robotic or laparoscopic rectal cancer surgery ((Ann Surgg 2015; 261:129-137). The authors concluded that “robotic surgery for rectal cancer failed to offer any oncologic or clinical benefit compared with laparoscopy” despite a 2.34 times higher cost than laparoscopic surgery.

I concur with this highly esteemed group of experienced robotic surgeoninvestigators. Moreover, the robotic

Quick Pulse Corner On the use of genomic testing/ genome sequencing in colorectal cancer.

Dr. Lacy: Life, science, medicine, … almost everything has been developed thanks to the existence of genes. And the future of colorectal surgery is to focus again on them.

Every day I have the opportunity to work with great experts in that area. Nevertheless, we must work to be able to give every patient a personalized treatment based on his or her own genetic features.

Dr. Gorfine: Therapeutic application of genomic testing is currently in its infancy.

Although we are regularly using molecular markers to identify patients with Lynch syndrome, for example, this application demonstrates only a fraction of the potential of this technology. “Personalized medicine,” based on an individual patient’s genome, will offer dramatic advances in colon cancer treatment and, hopefully, prevention.

Dr. Remzi: It is the future. Many unnecessary operations, chemoradiation therapeutic regimens will be avoided by it. It will guide us to tailor the correct surgical and nonsurgical modalities for our patients.

Dr. Lagares-Garcia: Clearly the combination of genetics and surgical treatment will standardize and personalize colorectal cancer care in the near future.

Dr. Efron: Genomic testing and sequencing will eventually guide therapy for colorectal cancer and be considered standard of care.

Dr. Wexner: There’s incredible value to this technology; the future of colorectal cancer care, and perhaps all of oncology, will be significantly and positively impacted. The idea of targeting therapy based on a patient’s predicted response to a treatment is tremendous, as is the ability to direct potential therapeutic benefits to patients most likely to respond and avoiding potential morbidity in patients unlikely to respond. Significant resources should be directed towards expediting development and maturation of this field.

platform is touted by its proponents and enthusiastically embraced by surgeons to “flatten” or “shorten” the “learning curve.”

The reduced learning curve should therefore allow surgeons who do not frequently operate on rectal cancers to do so in a minimally invasive fashion. Although the short-term recovery benefits of the minimally invasive approach to the patients seem inherently obvious, unfortunately the long-term oncologic problems of lowvolume surgeons have been well demonstrated. Numerous studies have shown that rates of permanent colostomy and local recurrence are in inverse proportion

to the volume of rectal cancer operations performed by individual surgeons and within individual institutions. Therefore, when robotic rectal cancer surgery is offered to patients by high-volume rectal cancer surgeons in high-volume rectal cancer centers, the oncologic outcomes are probably similar to the oncologic outcomes of either laparoscopy or open TME when performed by those same surgeons.

However, sadly, the widespread advent of “easier” minimally invasive access may potentially allow lower-volume surgeons to operate on rectal cancer, which could possibly result in a higher incidence of use

of permanent colostomy and a higher rate of local recurrence. Thus, the results of rectal cancer surgery are probably far less dependent on the method of access than on the expertise and commitment of the surgeon and the center at which the surgeon operates.

—Colleen Hutchinson is a communications consultant who specializes in the areas of general surgery and bariatrics.

She can be reached at colleen@ cmhadvisors.com.

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Experts Discuss Major Advances in Breast Cancer, Make Recommendations Margins, Axillary Dissection, Intra-op Radiotherapy, Genetics B Y C HRISTINA F RANGOU SAN FRANCISCO—What’s new in breast cancer surgery for 2015?

According to leading breast cancer specialists, surgeons will perform fewer axillary lymph node dissections, provide more genetic testing and counseling, offer selective neoadjuvant hormone therapy and work more closely with specialists from other disciplines.

In a standing room–only lecture hall at the 2014 Clinical Congress of the American College of Surgeons, eight well-known surgeons outlined the major advances in breast cancer from 2014, and made recommendations on how to improve care for patients.

Moderator Steven Chen, MD, MBA, a surgeon and vice president of clinical affairs at Avelas Biosciences, La Jolla, Calif., said, “If there’s one message to be heard about breast surgery this year, it is that as breast cancer care gets to be increasingly complex, the need to work as a team increases dramatically. Every step of the way has brought us closer to individualizing the right care for the right person, at just the right time, and to do that requires a team approach.”

Margins Margins were the biggest issue in breast cancer surgery in 2014. Last winter, the Society of Surgical Oncology and the American Society for Radiation Oncology issued consensus guidelines that set “no ink on tumor” as the appropriate margin for surgery in women undergoing breast-conserving surgery (BCS) with whole-breast radiation for stages I and II invasive breast cancer. The guidelines were based on a meta-analysis of margin width that showed no ink on tumor was associated with low rates of ipsilateral breast tumor recurrence (IBTR). At the same time, the slim negative margin has the potential to reduce re-excision rates, improve cosmetic outcomes and decrease health care costs.

Despite strong support from professional organizations, the no ink on tumor standard remains an uncomfortable one for many surgeons and pathologists, said Richard Gray, MD, co-director of the Breast Clinic at Mayo Clinic, Phoenix.

Even the authors of the meta-analysis acknowledged that there are gray areas when it comes to margins, Dr. Gray noted. Some of the studies included in the meta-analysis indicated that “close margins” are associated with higher rates of recurrence; however, those studies failed to define close margins.

Even so, no ink on tumor is a “reasonable step,” Dr. Gray said, adding that he was initially concerned about the new standard.

He cautioned that there are caveats to the no ink on tumor specification. Some patients with invasive breast cancer, particularly younger women or patients with multiple close margins, may be candidates for wider margins, he said.

“Keep in mind that no ink on tumor is a good place to start, given the caveats of appropriate multidisciplinary care. There will be patients that should be an exception to this rule and you need to use judgment.”

The guidelines do not address patients with ductal carcinoma in situ (DCIS), for whom appropriate margin width remains controversial. A widely cited meta-analysis published in 2012 concluded that “negative surgical margins should be obtained for DCIS patients after BCS regardless of radiotherapy. Within cosmetic constraint, surgeons should attempt to achieve negative margins as wide as possible in their first attempt ((J Natl Cancer Inst 104:507-516).

The authors reported that compared with a negative margin of greater than 2 mm, a 10-mm free margin was associated with a reduced risk for IBTR (odds ratio [OR], 0.46; 95% confidence interval [CI], 029-0.69).

However, there is support for a narrow margin in patients who undergo radiotherapy. A 2009 meta-analysis that was restricted to clinical al trials of women with DCIS who underrwent BCS plus radiotherapy found thaat a

On Margins ‘Keep in mind that no ink on tumor is a good place to start, given the caveats of appropriate multidisciplinary care.

There will be patients thaat should be an exception to this rule and you need to use judgment.’’

—Richard Gray, MD

On Axillary Dissection ‘I think we can say, “axillary lymph node dissection, rest in peace.”’

—Roshni Rao, MD

On Contralateral Prophylactic Mastectomy ‘We’re not taking the time to explain to [patients] their risk of local recurrence, distant metastases and that a prophylactic surgery does not reduce that risk.’

—Swati Kulkarni, MD

On Neoadjuvant Endocrine Therapy ‘Neoadjuvant hormonal therapy can improve your lumpectomy rate in [older patients or patients with comorbidities] by up to 40%.’

—E. Shelley Hwang, MD

On Intraoperative Radiation ‘Overall, I would say that whole-breast radiotherapy is still the gold standard. We are still learning who the best candidates for intraoperative radiotherapy may be.’

—Courtney A. Vito, MD

On Genetic Testing ‘It requires a good discussion with the patient and the family members to make a decision, and this is best done in the context of someone who has experience with these types of panels.’

—Doreen M. Agnese, MD

margin threshold of 2 mm “seems to be as good as a larger margin when BCS for DCIS is combined with radiotherapy” (J ( Clin Oncol 2009;27:1615-1620).

Dr. Gray recommended a 2-mm margin for patients with DCIS who undergo radiation, but he added, “Wider margins may be a single factor among others that can make us look toward avoiding radiation therapy in select patients.”

While no evidence suggests that margins that extend beyond no ink on tumor may be better for women undergoing mastectomy, Dr. Gray cautioned against extrapolating the guidelines to women having mastectomies.

“They will generally not undergo adjuvant radiation therapy,” he said.

After Mappin Mapping of the Axilla: Radiotherapy or Surgeryy?

Rooshni Rao, MD, associate professor of surggery at University of Texas Southwestern n Medical Center, Dallas, said she expects su urgeons will perform fewer axillary lymph node dissections after the report from the n AMAROS trial last fall (Lancet Oncol A 20 014;15:1303-1310).

In the Phase III, open-label, multicenter, non ninferiority trial, patients with T1-2 primary breast cancer and no palpable lymphadenopathy were randomized to either axillary lymph node dissection (AL (ALND) or axillary radiotherapy in the case of a positive node.

The study, which included 1,425 patients with a positive sentinel node, showed no significant difference in rates of recurrence between the groups. At a median follow-up of 6.1 years, 0.43% of women who underwent ALND developed a local recurrence compared with 1.19% of women who received axillary radiotherapy.

There was a significant difference in morbidity between the groups. Signs of lymphadenopathy were noted at five years in 23% of patients who underwent ALND, but only 11% of those treated with axillary radiotherapy.

“In our opinion, if further axillary treatment is needed in clinically node-negative, sentinel node–positive patients, axillary radiotherapy could be chosen instead of axillary lymph node dissection because it provides comparable axillary control,” the authors concluded.

This is the third study to conclude that axillary radiotherapy is noninferior to ALND. However, the two previous studies—the NSABP-04 trial and a French trial—were conducted before the introduction of sentinel node biopsy ((N Engl J Medd 2002;347:567-575; J Clin Oncoll 2004;22:97-101).

Dr. Rao said the latest study confirms that surgery unquestionably increases morbidity but without measurable benefits in potential recurrence. “I think we can say, ‘axillary lymph node dissection, rest in peace.’”

“In the past, it made sense to remove the lymph nodes so we could figure out what other treatments a patient may need. But nowadays, we can look at molecular profiling to help us make those decisions.”

Rising Rates of Contralateral Prophylaxis Swati Kulkarni, MD, associate professor of surgery at the University of Chicago’s Pritzker School of Medicine, called on surgeons to do a better job of communicating risk to breast cancer patients.

“We’re not explaining to them what their risk of contralateral breast cancer really is. We’re not taking the

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time to explain to them their risk of local recurrence, distant metastases and that a prophylactic surgery does not reduce that risk,” she said. “Take the time you need to educate your patients because we find that patients significantly overestimate the risks.”

She cited recent studies showing that women in the United States are undergoing contralateral prophylactic mastectomy (CPM) in ever-increasing numbers, despite a lack of strong evidence that this reduces the risk for contralateral cancer. A study in the September edition of the Journal of the American Medical Association reported that the rate of bilateral mastectomies rose from 2.0% in 1998 to 12.3% in 2011, representing an annual nual increase of 14.3% (312:902-914). The rise was mostt pronounced in young women: In women younger than 400 years, bilateral mastectomies jumped from 3.6% in 199 98 to 33% in 2011.

But there is little scientific justification n for CPM’s popularity, Dr. Kulkarni said. Ou utcomes for breast cancer patients improved over the past two decades while contralaterall breast cancer rates dropped. A 2011 study using Surveillance, Epidemiology, and End Results (SEER) data showed that incidence of contralateral breast cancer dropped substantially between 1975 and 2006 ((J Clin Oncoll 2011;29:1564-1569).

Since 1985, contralateral breast cancer rates fell about 3% annually in the United States,, a trend driven largely by improvements to treatment of estrogen receptor (ER)-posittive cancers, such as widespread use of adjuvant hormone therapy and other adjuvant treatments.

It is unclear whether CPM confers a surviival advantage, Dr. Kulkarni said. A 2010 Cochrane an nalysis found “insufficient evidence that CPM improvves survival” (Cochrane Database Syst Rev 2010:CD002748). But a retrospective study, also from 2010, reported that CPM was associated with a 4.8% absolute improvement in five-year breast cancer–specific survival in young women with early-stage, ER-negative breast cancer (J ( Natl Cancer Inst 2010;102:401-409). More recently, the California Cancer Registry study that showed rising rates of CPM also demonstrated that women who receive this procedure derive no survival benefit from the extra surgery.

Few studies have examined short-term outcomes after CPM, Dr. Kulkarni said. A study published in late 2013 reported that CPM patients were 1.5 times more likely to have any complication (OR, 1.53; 95% CI, 1.04-2.25; P P=0.029) and 2.7 times more likely to have a major complication compared with unilateral mastectomy patients (OR, 2.66; 95% CI, 1.37-5.19; P=0.004), P after adjusting for age, body mass index, smoking and diabetes history, American Joint Committee on Cancer stage, reconstruction, previous radiation therapy and adjuvant therapy (Ann ( Surg Oncol 2013;20:4113-4120).

Dr. Kulkarni urged surgeons to talk to patients about risks for contralateral breast cancer and question them about factors important in their decision.

Neoadjuvant Hormone Therapy E. Shelley Hwang, MD, professor of surgery at Duke University School of Medicine, Durham, N.C., urged surgeons to consider neoadjuvant hormone therapy, particularly for older patients or patients with comorbidities that rule out use of chemotherapy.

“Neoadjuvant hormonal therapy can improve your lumpectomy rate in these patients by up to 40%,” she said.

Three key studies have looked at neoadjuvant hormone therapy in women with breast cancer: the P024 trial, the

IMPACT study and ACOSOG Z1031. Together, these studies showed that neoadjuvant hormone therapy can improve a woman’s candidacy for BCS and that her response to hormone therapy is closely associated with ER expression. Among the highlights, the P024 trial reported that up to 45% of patients who were initially not eligible for lumpectomy became candidates for BCS after four months of letrozole ((Ann Oncol 2001;12:15271532). Even with tamoxifen, considered a less effective form of hormone therapy, 35% of women became good candidates for lumpectomy. “That is the important message for surgeons from this trial,” Dr. Hwang said.

The P024 trial reported that up to 45% of patients who were initially not eligible for lumpectomy became candidates for breast-conserving surgery after four months of letrozole.

Both the P024 and IMPACT trials showed that aromatase inhibitors generally provide a better response in ER-positive disease than tamoxifen.

Dr. Hwang recommended that surgeons use the Preoperative Endocrine Prognostic Index (PEPI) score to make decisions about treatment. First reported in 2008, the PEPI score predicts the risk for breast cancer recurrence in women who received neoadjuvant hormone therapy by looking at four breast cancer characteristics: pathological tumor stage, nodal status, Ki67 expression level and ER status (J ( Natl Cancer Instt 2008;100:13801388). A woman’s PEPI score may help identify whether she can safely avoid chemotherapy or if she should be considered for aggressive therapy because of a high risk for relapse.

A new Phase III study (ACOSOG Z11103), which opened a few months ago, aims to identify patients with ER-positive tumors that do not require chemotherapy despite being a large size. Results from the trial, known as ALTERNATE, are not expected for several years.

The Case for Intraoperative Radiation Although whole-breast radiation remains the standard, evidence is building for targeted intraoperative radiotherapy, said Courtney A. Vito, MD, assistant clinical professor and staff surgeon at City of Hope Comprehensive Cancer Center, Duarte, Calif.

Since 2013, two trials that compared targeted breast radiation and whole-breast radiotherapy have demonstrated that the targeted approach may be advantageous.

In November 2014, investigators reported five-year results from the TARGIT-A trial, which randomized women older than 45 years with invasive ductal

carcinoma to receive single-dose targeted intraoperative radiotherapy (TARGIT) or fractionated external beam radiotherapy (EBRT). The patients were enrolled at 33 centers in 11 countries, between 2000 and 2012.

When TARGIT was performed concurrently with lumpectomy, the five-year risk for local recurrence was comparable to that of EBRT: 2.1% versus 1.1%.

But when TARGIT was delayed and performed after lumpectomy, recurrences occurred in 5.4% of patients, a rate much higher than that for whole-breast radiation.

In a second significant finding from the trial, breast cancer mortality was reported to be the same in the two groups, but there were significantly fewer non–breast cancer d deaths with TARGIT, at 1.4% versus 3.5 % with EBRT. M Much of the difference was attributable to fewer deaths ffrom cardiovascular causes.

“Whoole-breast radiation when applied to the left side of the chest c can accelerate atherosclerosis of the heart.

This does not imply that the external beam caused the card diac death but there is more room for study here,” Drr. Vito said.

A 2013 study also indicates a role for targgeted intraoperative radiotherapy. Five-year results of the Electron Intra Operative Radiatiion Therapy (ELIOT) trial showed no differeence in overall survival between women treated with whole-breast external radiotherapy or intraw op perative radiotherapy with electrons (Lancet Oncoll 2013;14:1269-1277). However, there was a substantial disparity in IBTR. Five years after treatment, 4.4% of women in the intraoperative rad diotherapy group developed a recurrence compared w with 0.4% in the EBRT group (OR, 9.3; 95% CI, 3.3--26.3).

But ssubset analyses demonstrated that most recurrences w were in women who would not be considered candidates for intraoperative radiotherapy in the United candidat States because they had tumors larger than 2 cm, four or more positive lymph nodes, ER-negative tumors or other aggressive tumor biology.

“Without this high-risk group, the data look a lot better,” Dr. Vito noted.

“Overall, I would say that whole-breast radiotherapy is still the gold standard. We are still learning who the best candidates for intraoperative radiotherapy may be,” she said. “Clearly, application to a wide spectrum of patients is not advised. I would recommend patients who undergo this do so with a comprehensive breast cancer team and preferably on [a] trial, and they need very close long-term follow-up.”

Genetic Testing Doreen M. Agnese, MD, associate professor of surgical oncology and human genetics at Ohio State University, and chief of surgical services at James Cancer Hospital, Columbus, said surgeons should undergo training in genetics or work closely with health care providers who have training in cancer genetics.

It is becoming increasingly complicated to select the appropriate genetic tests for breast cancer patients and to counsel patients accordingly, she said. Today, many companies offer gene panels, with prices ranging from $1,500 to $6,000, depending on the number of genes analyzed.

“It requires a good discussion with the patient and the family members to make a decision, and this is best done in the context of someone who has experience with these types of panels,” Dr. Agnese said.

Dr. Hwang disclosed an advisory role for Genomic Health.

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Dear Readers, Welcome to the spring international issue of The Surgeons’ Lounge.

Our guest experts Eduardo Parra-Davila, MD, director of Minimally Invasive and Colorectal Surgery, director of Hernia and Abdominal Wall Reconstruction, Celebration Health, Florida Hospital, Kissimmee, Fla., and Conrad Ballecer, MD, MS, co-director of the Center for Minimally Invasive and Robotic Surgery, Arrowhead Hospital and Banner Thunderbird Medical Center, Glendale, Ariz., will be discussing robotic repair of ventral hernias. We welcome your questions and comments!

Sincerely, Samuel Szomstein, MD, FACS Editor, the Surgeons’ Lounge Szomsts@ccf.org

The Surgeons’ Lounge

Dr. Szomstein n is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston

Question for Eduardo Parra-Davila, MD, and Conrad Ballecer, MD Carlos Hartmann, MD, staff surgeon Centro Medico Guerra Mendez, Valencia, Venezuela

There has been an increase in robotic technology involved in the repair of ventral hernias in the past year.

• Why do you use the da Vinci robot in the repair of ventral hernias?

• • •

Is it easier to close the hernia defect robotically?

Where can the mesh be placed robotically to reinforce the repair?

Can robotics facilitate the bilateral component separation technique described as posterior transverse release?

Drs. Parra-Davila and Ballecer’s

Reply

In 2004, the American Hernia Society concluded in their consensus statement that the Rives-Stoppa repair of ventral hernias was the standard by which all open hernia repairs should be judged (Surg Clin North Am 2008;88:1083-100; Am J Surg 2012;204:709-716). Although shown to be a durable repair, wound complications oftentimes result in unacceptable patient morbidity. To decrease wound morbidity, laparoscopic ventral hernia repair (LVHR) emerged and resulted in negligible wound morbidity and low recurrence rates (Ann ( Surgg 2003;238:391-399).

Laparoscopic repair of incisional hernias was first introduced in 1992, leading to improved recovery time and reductions in hospital length of stay, complication rates and cost (Ann ( Surgg 2003;238:391399; Surgeryy 2005;138:708-715). Published recurrence rates have been reduced to less than 9% (Surg Endoscc 1999;13:250252; Surg Laparosc Endoscc 1998;8:294299; Surg Endoscc 2000;14:419-423; J Am Coll Surgg 2000;190:645-650). These recurrences have been attributed mainly to improper positioning of the mesh (with <3 cm overlap of mesh and fascia)

and to the use of tacking or stapling devices for fixation rather than abdominal wall suturing using suture passers (J ( Am Coll Surgg 2000;190:645-650; Am J Surg 1999;177:227-231).

Although laparoscopic repair has been associated with faster recovery, fewer complications and a lower recurrence rate compared with the open technique, there continues to be a significant incidence of postoperative pain associated with the transabdominal wall sutures. Several authors have reported a 2% incidence of significant postoperative pain lasting more than two to eight weeks after repair (Surg Endoscc 2000;14:419-423; JSLS 2003;7:7-14; Surg Endoscc 2006;20:7175; World J Surgg 2012;36:447-452; Am Surgg 2006;72:808-813; J Gastrointest Surg 2004;8:670-674). Significant postoperative pain has also been described in association with tacks. The pain is described by patients as a point of constant burning in a dermatome pattern at the points of transabdominal sutures or tacks, and has been attributed to tissue and nerve entrapment.

The da Vinci robot (Intuitive Surgical) offers numerous advantages over

laparoscopy, including several degrees of motion, three-dimensional imaging, and superior ergonomics that enables easy and precise intracorporeal suturing. Other reports have demonstrated the ease of intracorporeal suturing of the mesh to the abdominal wall ((JSLS 2003;7:7-14). Thus, this device is an ideal tool for intracorporeal suturing of mesh to the posterior fascia of the anterior abdominal wall for ventral hernia repair. Whereas previous reports have confirmed the need to suture the mesh at 2- to 5-cm intervals as a means of reducing the recurrence rates associated with laparoscopic hernia repairs, we believe that continuous circumferential suturing applies those principles while evenly distributing the tension throughout the mesh (Surg Endoscc 2000;14:419423; J Am Coll Surgg 2000;190:645-650; Am J Surgg 1999;177:227-231).

The entire repair is performed under direct visualization, with precise placement and confirmation of depth into the posterior fascia for all sutures placed. The fascial sutures encompass 1-cm bites of fascia, minimizing trauma to the abdominal wall.

Intracorporeal suturing of the fascia allows the midline to be reapproximated, facilitating possible primary repair, more physiologic abdominal wall movement and greater overlap of the mesh to the defect’s fascial edges. Robot-assisted LVHR offers yet another advantage by providing the suturing option under excellent visualization for the repair of difficult hernias with bony or muscular margins, such as lumbar, suprapubic and subcostal hernias. Several patients have hernias on or near lateral borders of the abdomen, making mesh fixation with tacks difficult. The robotic platform allows the surgeon to take precise bites of tissue to anchor the mesh repair.

Limitations of this robot-assisted technique are obvious. Large ventral

hernias, as they approach the working ports and camera, make this technique technically challenging for the robotic arms to be placed and to be able to work with the angulations needed or when the amount of redundant skin is large and removal of soft tissue is indicated.

Traditionally, LVHR involves three primary steps: 1) gaining safe access to the abdomen, 2) adhesiolysis, and 3) placement and fixation of a large overlapping sheet of tissue separating mesh.

Technically speaking, this approach illustrates the four shortcomings of this surgical approach. Adhesiolysis is the Achilles heel of this procedure due to its technical difficulty, most notably in recurrent hernia, and previous mesh placement increasing the risk for iatrogenic enterotomies. This difficulty is accentuated by poor ergonomics and the demands of applying nonarticulating instruments high on the anterior abdominal wall. Second, bridging defects may predispose to migration or eventration of the mesh into the defect and seroma formation. Third, the requirement for circumferential tacks and multiple full-thickness transfascial sutures to adequately secure the intraperitoneal onlay mesh (IPOM) predispose to both acute and protracted pain ((J Gastrointest Surgg 2002;8:670-674; Am Surgg 2003;69:688-691). Lastly, in a certain group of patients, leaving mesh in the intraperitoneal area may complicate future surgical intervention (World J Surgg 2003;31:423-429).

Robotic ventral hernia repair may resolve these shortcomings by allowing the operator to offer traditional open repair techniques through minimally invasive incisions.

Robotic repair of ventral hernias was first described in 2002 by Garth Ballantyne, MD (Surg Endosc 2002;16:1389-1402). Improved visualization, tremor-free precision and

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superior ergonomics form the basis for the emergence of robotic techniques in the hernia space.

Preoperative Considerations Obtaining a thorough history and physical examination is mandatory to coordinate an operative plan. Specifically, comorbidities such as diabetes, obesity, smoking and collagen vascular disease may critically affect the operative plan.

A computed tomography scan of the abdomen and pelvis is critical to preoperative planning and remains the gold standard imaging test. This imaging modality can delineate the size and location of the hernia defect, the content of the hernia, sac, and possibly the position of previously placed mesh.

A complete medical history along with imaging offers the opportunity for surgeons to construct a risk–benefit ratio. This scale can then be presented to the patient so he or she can make an informed decision about whether or not to proceed with surgery and what kind of repair is best for the specific hernia.

Repair Techniques Hernia repair techniques amenable to the robotic approach include: • IPOM bridge • IPOM after primary closure of the defect • Preperitoneal placement of mesh • Placement of retromuscular mesh with or without posterior component separation The individual technique is chosen based on location of the hernia defect, size of the defect and, perhaps most importantly, surgeon experience.

Below is a detailed description of each technique.

Robotic Rives-Stoppa Repair With Bilateral Transversus Abdominis Release The retromuscular hernia repair as described by Rives is considered by many to be the standard by which all hernia repairs are judged. The posterior component separation technique allows for the closure of large hernia defects with wide prosthetic mesh overlap. These two techniques performed in tandem have traditionally been exclusive to open hernia repair (Surg Clin North Am 2008;88:1083-1100; Am J Surgg 2012;204:709-716; Plast Reconstr Surgg 1990;86:519-526; Chirurgie 1985;111:215-225).

The retromuscular repair as described

by Rives uses the natural myofascial planes of the abdominal wall while preserving the integrity of the subcutaneous tissue (Chirurgiee 1985;111:215-225). In this technique, mesh is secured in the retrorectus position, sandwiched by closure of the anterior fascia above and by

Figure 1. Patient positioning and trocar placement.

Figure 3. Anatomy of the posterior dissection.

Figure 5. Division of the transversus abdominis muscle.

Figure 2. Posterior sheath incision.

Figure 4. Incision of the lateral posterior sheath.

Figure 6. Preperitoneal dissection.

the posterior fascia below. With recurrence rates reported to be in the range of zero to 4%, many consider this technique of open ventral hernia repair as the gold standard for all hernia repairs (Surg Clin North Am 2008;88:1083-100; Am J Surg 2012;204:709-716). The limitation of the Rives-Stoppa repair is that the maximal transverse diameter of the mesh is confined to the lateral edge (linea semilunaris) of the rectus muscles.

The transversus abdominis muscle release, as described by Novitski et al, involves incision of the lateral posterior sheath, identification and division of the transversus abdominis, and dissection of the preperitoneal space ((Am Surg 2006;72:808-813). This modification allows for wide release and advancement of the posterior rectus sheath and peritoneum below the arcuate line, preservation of the neurovascular bundle serving the rectus abdominis, and wide lateral dissection to the level of the lateral border of the psoas muscle. In the setting of large incisional hernias, this technique allows for reconstruction of the linea alba, reapproximation of the rectus to the midline, placement of a large overlapping mesh unlimited by the confines of the linea semilunaris, and closure of the posterior sheath.

Although considered an effective and durable technique with low recurrence rates, trauma to the abdominal wall via open hernia repair is associated with a high incidence of wound complications, including mesh infections, which may lead to unacceptable patient morbidity ((J Gastrointest Surgg 2002;8:670-674; Am Surgg 2003;69:688-691). Use of the da Vinci robot has enabled minimally invasive replication of this technique traditionally reserved for open repair.

Abdominal wall reconstruction by posterior component separation

mandates dissection of individual layers of the abdominal wall intended to primarily close large hernia defects, create a large space for the placement of a reinforcing prosthetic mesh, and ultimately restore the anatomy and physiology of the abdominal wall. Therefore, a thorough knowledge of the anatomy of the abdominal wall is critical to optimizing patient outcomes. Hernia repair by abdominal wall reconstruction and component separation should be regarded as the definitive repair for large hernias under tension due to the wide defects in the fascia.

Transversus Abdominis Release The uniform retraction afforded by pneumoperitoneum allows dissection within an avascular plane to the level of the linea semilunaris. The neurovascular bundle serving the rectus is exposed and preserved. An incision is made in the lateral posterior sheath of the upper third of the abdomen where the medial fibers of the transversus abdominis muscle are most prominent. The muscle is exposed and divided along the extent of posterior sheath and peritoneal dissection (Figures 3-6). This step allows entry and dissection into the preperitoneal space, resulting in wide release of both the posterior and anterior sheaths.

When sufficient posterior sheath release has been accomplished, mirror image trocars are placed on the contralateral abdomen; the robot is undocked; and the patient is rotated 180 degrees and the robot is redocked. (This step is eliminated by the rotational capability of the da Vinci Xi.) The contralateral posterior sheath is then dissected and the steps above are repeated.

Closure of the Anterior Sheath, Mesh Placement, and Posterior Sheath Closure Closure of the anterior sheath is accomplished by using a 0 V-loc (Covidien) suture in a running fashion. The subcutaneous tissue and hernia sac are incorporated into the closure to obliterate the anterior dead space. This step restores the linea alba and the rectus abdominis muscle to the anatomically and physiologically correct position (Figure 7).

The extent of dissection is measured in cranial-caudal and axial dimensions to choose an appropriately sized mesh.

Light or midweight polypropylene mesh is positioned by a single central

Patient Positioning, Trocar Placement and Docking For the majority of patients with large defects in the midline, supine positioning with the arms tucked is preferred, unless trocar access to the lateral abdomen is obscured. Trocars are placed in the lateral abdomen similar to conventional laparoscopic repair. Optical trocar technique, preferably in a location remote from previous surgical intervention, is used to gain initial access. An 8to 12-mm trocar is placed in the lateral abdomen and then two 8-mm trocars follow on each side of this trocar (Figure 1).

Essential Steps Posterior Sheath Incision The anterior abdominal wall is cleared of all adhesions to adequately define and size the hernia defect. The retromuscular space is accessed by incision and subsequent mobilization of the posterior sheath. Below the arcuate line, the peritoneum and transversalis fascia are mobilized in a similar fashion. The degree of cranial-caudal dissection is based on the size of the defect, ensuring a minimum of 5 cm of overlap (Figure 2).

continued ON PAGE 16

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jContinued from page 15 transfascial suture in the retromuscular position. Circumferential fixation is accomplished with absorbable tacks or suture (Figure 8).

The posterior sheath is then reapproximated using 0 V-loc long-term absorbable suture (Covidien). It is often helpful to incorporate a bit of mesh to elevate the two leaves of the posterior sheath away from the intraabdominal viscera. The peritoneum is reapproximated below the arcuate line (Figure 9).

Drain Placement Secondary to pneumoperitoneum, the retromuscular space represents a large potential area for seroma formation. Trocars are withdrawn from the

READMISSIONS jContinued from page 1

Figure 7. Closure of defect.

Figure 8. Placement of mesh after closure of defect.

Figure 9. Posterior sheath closure.

intraperitoneal cavity into the retrorectus space. In this position, adequate hemostasis can be confirmed and two 19 F drains are placed.

In summary, the technique of robotassisted laparoscopic incisional hernia repair with intracorporeal closure of the

fascial defect and continuous circumferential suturing for mesh fixation is feasible, and may reduce postoperative pain by eliminating transfascial sutures. The component separation techniques done robotically may decrease the incidence of wound infections in this difficult group

of patients.

Further evaluation is needed, and longterm data are lacking to assess the benefit to the patient, but early results are encouraging, especially for postoperative pain and wound infections compared with laparoscopic or open procedures.

Based on Stanford’s experience, DROP organizers put together videos for patients to watch prior to surgery and set out multidisciplinary care bundles that can help manage care components such as dehydration, dietary concerns and medication issues.

In the study presented at the ACS meeting, the most common readmissions were related to gastrointestinal (45%), dietary (33.5%) and bleeding (6.57%) problems, that bariatric surgical programs can target by careful discharge planning, Dr. Morton said.

“That’s where you see opportunity for improvement,” he pointed out.

The study also identified patients at high risk for readmission. Patients who were readmitted to hospital were more likely to have a body mass index greater than 50 kg/m2 (30.2% vs. 24.6% for patients who were not readmitted; P<0.001); have a longer operating time (115 vs. 132 minutes; P<0.001), have a hospital length of stay of more than four days (9.57% vs.

3.36%; P<0.001) and have a preoperative diagnosis of diabetes (31.1% vs. 27.7%; P<0.02).

“What’s helpful about that is [that] for patients at a higher risk of readmission, we escalate coordination of care early on,” Dr. Morton said.

The study also showed that complications are the primary cause of readmission.

Postoperative factors associated with a return to hospital included surgical

fill prescriptions before discharge from the hospital.

The study comes as the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), a program that establishes national standards for facilities and surgeons performing bariatric surgery, launches its first national quality improvement project, Decreasing Readmissions through Opportunities Provided, known as DROP. DROP aims to reduce readmissions within 30 days of surgery by 20% at 700 accredited bariatric centers throughout the United States, which could prevent approximately 1,500 bariatric surgery readmissions and save about $525 million.

Beginning in February 2015, the program will be rolled out at about 100 randomly selected bariatric surgery centers in the United States. DROP will be implemented and evaluated over the next 12 months before a final version is extended to all MBSAQIP centers, said Stacy Brethauer, MD, associate director of Cleveland Clinic’s Bariatric and Metabolic Institute, in Ohio.

DROP was first piloted in 2008 by Stanford’s bariatric surgery department. Over several years, Stanford reduced its bariatric surgery readmissions by 75% by implementing changes in patient education, discharge planning and pre- and postoperative checklists. Among the changes, staff provided patients with a help card that listed phone numbers for patients to call if they had concerns, which often saved them a trip to the emergency department. Patients were given branded water bottles to emphasize the need for proper hydration. Staff put together a detailed discharge checklist that included questions about home care, nutrition and pain. After patients were discharged, a registered nurse called each patient at home the next day to check in on them.

Risk Factors for Readmission After For patients having problems, same-day Bariatric Surgery appointments were made readily available. By 2012, readmissions fell to 2%, • Body mass index >50 kg/m2 down from 8% four years earlier.

• Longer operating time “When we drilled down into the • Hospital length of stay >4 d causes, we were able to significant• Preoperative diabetes diagnosis ly decrease readmissions. We hope to pass that on to other centers,” Dr. Morton said.

site infections (15.5% vs. 1.15% among patients who did not have a readmission to hospital), urinary tract infections (3.65% vs. 0.65%), deep vein thrombosis (3.58% vs. 0.13%) and, most significantly, a return to the operating room (22.6% vs. 0.92%; P<0.001 for all).

Logistic regression analysis found that readmission was significantly associated with complications, with an odds ratio of 11.3 (P<0.001).

The DROP program does not address complications, but future MBSAQIP quality initiatives will focus on complications, Dr. Brethauer noted. “One of the take-home messages from this study is that preventing complications from the primary surgery probably will go the farthest in preventing readmissions in our specialty.”

Richard D. Stahl, MD, assistant professor and medical director of bariatric surgery, University of Alabama at Birmingham, said bariatric surgery in the United States has made great strides over the past decade by paying attention to detail, learning from colleagues and never being content with the status quo.

“I think it’s in this vein that the DROP program should be viewed, and why it is so admirable …. They think, and I think, we can do better and that, after all, is the mission of all dedicated bariatric surgeons. If we can make [bariatric surgery] better, then it is unacceptable not to improve,” Dr. Stahl said.

Postoperative Risk Factors Associated With Return to Hospital • Surgical site infections • Urinary tract infections • Deep vein thrombosis • Return to operating room

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ProCESS Trial May Lead to Sepsis Protocol Tweaks B Y P AUL B UFANO

T

hirteen years ago, a seminal study on early, protocol-driven therapy for severe sepsis showed that the aggressive intervention boosted survival in these critically ill patients. Now, a new look at the treatment strategy suggests that such a rigid approach may be no more effective than current bedside treatments.

The original single-center study (N Engl J Medd 2001;345:1368-1377) found that in-hospital mortality was significantly reduced in patients with severe sepsis or septic shock who were treated based on a six-hour protocol of early goal-directed therapy (EGDT) compared with those who were provided usual care (30.5% vs.

46.5%, respectively). The protocol consisted primarily of central venous catheterization to monitor central venous pressure and oxygen saturation, along with a targeted resuscitation strategy.

To determine if the findings from that study are still generalizable, and to assess whether all of the protocol components are still needed, investigators conducted the ProCESS (Protocolized Care for Early Septic Shock) trial (N Engl J Med 2014;370:1683-1693). They enrolled 1,341 patients from 31 emergency departments across the United States. Of these patients, 439 were randomly assigned to EGDT, 446 to protocol-based standard therapy and 456 to usual care. Resuscitation approaches varied regarding the observation of central venous pressure and oxygen, and the use of vasopressors, inotropes, IV fluids and blood transfusions.

At 60 days, there were 92 deaths in the EGDT group (21%), 81 in the protocolbased standard therapy group (18.2%) and 86 in the usual-care group (18.9%). These differences in mortality were not statistically significant, the investigators reported. There also were no major disparities in 90-day mortality, one-year mortality and necessity for organ support. As a result, the researchers concluded that there was no substantial advantage, with respect to death or illness, of protocol-based resuscitation over the current standard.

The design of the ProCESS trial has several merits compared with the earlier research, according to Ishaq Lat, PharmD, FCCM, clinical coordinator of critical care at University of Chicago Medical Center, who was not involved with either study. He noted, for example, that the randomized controlled trial design of ProCESS was impressive, given the challenge of screening and enrolling patients with severe sepsis in hectic critical care settings. Moreover, “including patients from all over the country makes [the newer study] a better representation

of patients with severe sepsis and septic shock than before, and gives it a broader level of relevance.”

But he stressed that the ProCESS study results should be interpreted in the context of acknowledging the last decade of improved sepsis management. “The initial NEJM M trial called for early recognition to institute treatment with antimicrobial agents, timely administration of fluids and vasopressor agents, and conservative transfusion thresholds—all of which are

now reflective of the care in most institutions today,” Dr. Lat said.

That would explain, he added, why survival in the usual-care arm of the ProCESS trial was significantly increased compared with survival in the original goal-directed resuscitation study. “This may well be representative of the dramatic improvement in sepsis treatment that we’ve seen in recent years,” he said.

To make future studies more relevant to real-world clinical practice, “perhaps

we select an end point other than [survival], such as health care resources or patient quality of life,” Dr. Lat suggested. “Or maybe we should design smaller studies that won’t impact a heterogeneous pool of patients with the syndrome, leading to more patient-specific treatment strategies, such as those that have been developed for heart failure or hypertension.”

The study was supported by a grant from the National Institute of General Medical Sciences.

46th World Congress of Surgery International Society of Surgery (ISS) Société Internationale de Chirurgie (SIC) 23-27 August 2015

Bangkok Convention Center, Centara Grand at Central World

Bangkok, Thailand Jointly organised with

Royal College of Surgeons of Thailand and the ISS/SIC Integrated Societies

International Association of Endocrine Surgeons (IAES) International Association for Trauma Surgery and Intensive Care (IATSIC) International Association for Surgical Metabolism and Nutrition (IASMEN) Breast Surgery International (BSI) International Society for Digestive Surgery (ISDS) Alliance for Surgery and Anesthesia Presence (ASAP)

www.wcs2015.org Deadline of on-line Abstract Submission is strictly January 12, 2015

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

Robert Bárány: Nobel Surgeon’s Study of Ear Remains Relevant Unlocks Function of Vestibular Apparatus, Which Affects Eyes, Balance and Coordination B Y V ICTORIA S TERN

A

lthough the inner ear may not come to mind when considering an essential part of the body, this structure wields incredible control over us.

In the early 1900s, Robert Bárány, a surgeon from Vienna, investigated the functions of the vestibular apparatus, the sensory system that provides the greatest influence on movement and balance. He developed caloric, rotational and pointing tests to examine each ear individually, described nystagmus, a condition defined by involuntary eye movement, and unraveled the relationship between the inner ear and the brain.

Dr. Bárány’s pioneering work on the physiology and pathology of the vestibular apparatus was recognized by the Nobel Committee, and in 1914, he was awarded the Nobel Prize in Physiology or Medicine, becoming the fourth surgeon to ever receive this honor. Today, more than a century after his discoveries, Dr. Bárány’s insights and tests remain relevant to otolaryngology.

“Dr. Bárány’s contribution to our understanding of the vestibular system remains a great accomplishment,” said Ann Tucker Gleason, PhD, associate professor of clinical otolaryngology and director of the Vestibular and Balance Center, Department of Otolaryngology– Head and Neck Surgery at the University of Virginia School of Medicine, Charlottesville. “There are very few other things in medicine that we are still using 100 years later in almost the exact same way.”

Robert Bárány was born on April 22, 1876, near Vienna. His father, Ignaz Bárány, managed a farm estate and his mother, Marie Hock Bárány, was the daughter of a well-known Prague scientist, whose intellectual ideas deeply influenced her family, especially her son.

As a child, Dr. Bárány came down with tuberculosis of the bone, which caused permanent stiffness in his legs. He managed, however, to overcome his troubles by playing tennis throughout his life.

“In fact, this illness may have helped fuel his interest in science and medicine,” Dr. Tucker Gleason said.

Dr. Bárány was an excellent student, and in 1890, he received his medical degree from the University of Vienna.

After his medical studies, Dr. Bárány lived in Germany for two years where his interest in neurology emerged and blossomed.

He studied internal medicine in Frankfurt with pathologist and internist Carl von

The Bárány rotating chair revealed the function of both inner ears together and made surgical treatment of vestibular organ diseases possible. Development of the chair led to Bárány receiving the Nobel Prize in 1914.

Source: The National Institutes of Health

Noorden as well as neurology and psychiatry in Heidelberg under Emil Kraepelin, who is considered the founder of modern scientific psychiatry. On his return to Vienna, Dr. Bárány received hospital surgical training.

In 1903, Dr. Bárány began working in the otology clinic at the University of Vienna, directed by Adam Politzer, who had established the specialty in Austria.

As a young scientist caring for patient after patient in the clinic, Dr. Bárány began to see interesting patterns emerge.

Most notably, after syringing patients’ ears, Dr. Bárány noticed that many complained of vertigo. He also observed that these patients experienced nystagmus.

Although Dr. Bárány knew something important was happening, he only unlocked the mystery after a particularly serendipitous encounter with a patient.

One day in the clinic, while syringing a patient’s ear, Dr. Bárány recalled the patient saying: “Doctor, I only get giddy when the water is not warm enough.

When I do my own ears at home and use warm enough water, I never get giddy.”

Dr. Bárány subsequently asked a nurse to give him warmer water for the syringe, and upon irrigation of the ear canal with warm water the patient exclaimed: “But Doctor, this water is much too hot and now I am giddy again.”

Dr. Bárány immediately observed the patient’s eyes and saw the direction of

the nystagmus had changed after he had switched from cold to hot water. In that moment, Dr. Bárány understood what was causing nystagmus: “It came to me then in a flash that obviously the temperature of the water was responsible for the nystagmus. From this, I immediately drew certain conclusions. If the temperature of the water was really responsible, then water at exactly body temperature should cause neither nystagmus nor vertigo. An experiment confirmed this conclusion. Furthermore, I said to myself, if it is the temperature of the water, nystagmus must be caused in normal cases also and not only in cases of suppurating ears. This I was also able to prove.”

By 1906, Dr. Bárány had developed a simple test, called the Bárány caloric test, which he used to diagnose problems with the semicircular canals of the inner ear by syringing the ear with either hot or cold water. The test could discern the degree of responsiveness of the vestibular system and how symmetric the responses were between left and right ears.

“Dr. Bárány’s keen clinical observation led him to this critical discovery,” Dr. Tucker Gleason said. “For the first time, physicians could induce a sense of rotation without actually rotating the patient, but by irrigating the ear canal with water that was above or below body temperature. Importantly, he had also devised a

way to test each ear individually without destroying either.”

Dr. Bárány soon found that the endolymph—the body temperature fluid contained in the labyrinth of the inner ear—displaced itself, sinking in the presence of hotter water and rising in the presence of colder water. He realized that the motion of fluid affected the nerves in the semicircular canal, which are in direct contact with those that control the central eye muscles.

“We can understand, therefore, why stimulation of the semicircular canal causes nystagmus of the eyes,” Dr. Bárány explained in his Nobel speech. “The importance of this reaction in the diagnosis of diseases of the inner ear was obvious.”

Notably, the semicircular canal nerve also branches into the cerebellum, which controls motor function throughout the body. Thus, he found that disturbances of the semicircular canal not only caused nystagmus, but could also explain the resulting problems with balance and coordination. If patients did not respond to such disturbances, he knew that the semicircular canals had been severely damaged or destroyed. Dr. Bárány’s work led him to develop the Bárány rotating chair, which revealed the function of both inner ears together, and made surgical treatment of vestibular organ diseases possible.

The scientific establishment immediately recognized Dr. Bárány’s pivotal work and awarded him the Nobel Prize in 1914. At the time, however, Dr. Bárány was serving as a civilian surgeon in the Austrian Army in World War I. During these years, Dr. Bárány observed the effect of head injuries on coordination and continued to study the connection between the vestibular apparatus and nervous system. He also developed a technique for suturing head wounds and caring for bullet wounds to the brain.

In April 1915, Dr. Bárány was captured by Russian troops and held prisoner in a Russian war camp. In 1916, Prince Carl of Sweden intervened on his behalf and negotiated his release. That year, Dr. Bárány attended the Nobel Prize awards ceremony and officially received his prize.

Despite his accomplishment and harrowing wartime experiences, Dr. Bárány was welcomed home to Vienna with controversy, not open arms. Some of his colleagues felt he had taken credit for others’ ideas, such as the caloric reaction, and presented them as his own.

Although such controversy over intellectual ownership is quite common for Nobel Prize winners, the accusations in this case seemed exaggerated. Dr. Bárány had made no secret of the strong influence his predecessors had imparted on

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

him. In fact, Dr. Bárány spent about half his Nobel speech giving credit to his peers for their important contributions. In his lecture, Dr. Bárány referenced the work of Prosper Ménière who observed vertigo and tinnitus in inner ear disease in 1861; he discussed the efforts of Friedrich Goltz who, in 1870, deduced that the semicircular canal apparatus must maintain balance; and he referenced the theories of Josef Breuer, Ernst Mach and Alexander Crum-Brown, who all independently uncovered that the semicircular canal was a sensory organ necessary for the perception of rotary motion and responsible for vertigo. He also spoke highly of the experiments of Dutch anatomist Louis Balk and physiologist W. Trendelenburg, who elucidated key functions of the cerebellum in mammals.

The Nobel Prize committee investigated these accusations and concluded they were foundationless, but the controversy was strong enough to push Dr. Bárány out of Vienna. In 1917, he moved to Sweden and became director of the otorhinolaryngology clinic at the University of Uppsala. There, he focused on the function of the cerebellum and the causes of muscular rheumatism, and developed a surgical technique for treating chronic sinusitis, for which he received the Jubilee Medal of the Swedish Society of Medicine in 1925.

Although little is known of his personal life, Dr. Bárány was reportedly a quiet man who was devoted to his work. “From his Nobel speech, one can glean that he was good-natured and had the keen mind of [a] scientist, carefully observing his

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The Role of Robotics in the General Surgery Practice

‘For the first time, physicians could induce a sense of rotation without actually rotating the patient, but by irrigating the ear canal with water that was above or below body temperature.’

—Ann Tucker Gleason, PhD patients, creating hypotheses and testing them,” said Dr. Tucker Gleason.

Dr. Bárány married Ida Felicitas

Berger in 1909 and had three children, all of whom entered the sciences—one son became a professor of internal medicine, another son became a professor of pharmacology and his daughter became a psychiatrist.

In the last years of his life, Dr. Bárány had several strokes, which left him partially paralyzed, and he died in Uppsala on April 8, 1936, just short of his 60th birthday.

Reflecting on Dr. Bárány’s legacy, Dr. Tucker Gleason said, “Dr. Bárány provided us with a test that can be easily applied in the clinic with very basic

equipment to determine whether a person’s inner balance sensors are functioning as they should.”

Not only is Dr. Bárány’s work still used in the clinic today, but also, with the growing aging population, his work on balance has become increasingly important.

“Falls are a leading cause of accidental death and injury in people over [age] 65,” said Dr. Tucker Gleason. “Alongside dementia, balance issues in the elderly are becoming a public health crisis, which makes Dr. Bárány’s work more relevant than ever before.”

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In the News ROBOTICS

jcontinued from page 1 laparoscopy for many operations, I found the robot to have an edge over laparoscopy for complex abdominal operations, particularly operations requiring suturing and reconstruction and ones that may involve significant bleeding, which may be difficult to control laparoscopically.

Some of these complex oncologic procedures include the pancreaticoduodenectomy (Whipple). This can be done laparoscopically, but the conversion rate to laparotomy may be lower with the robotic approach. I’ve also utilized the robotic approach for gastric cancers, since I believe the visualization and ability to perform a comprehensive lymphadenectomy is superior. Similarly, I have used it for liver resections, particularly for lesions located in the challenging posterior segments of the liver, since these are areas that are hard to resect using standard non-wristed laparoscopic instruments, or may require a substantial laparotomy in order to remove a relatively small specimen.

The robotic platform may be particularly applicable to patients with higher BMI [body mass index], since these operations may be challenging with greater complication rates. The ability to complete these complex resections in minimally invasive fashion may prove to be particularly advantageous in this subgroup of patients.

Of the 500 robotic pancreas cases done at the University of Pittsburgh, almost 250 were Whipples, 125 were distal pancreatectomies and the remaining cases were a combination of central pancreatectomies, total pancreatectomies, total pancreatectomies with auto islet transplantations, enucleations, Puestow-type procedures, and cystgastrostomies for pancreatic pseuodocysts or walled-off necromas. This variety of cases is a testament to the versatility of this platform.

GSN:: You just published an important study in the Journal of the American Medical Association. Can you tell us about that study?

Dr. Zureikat: It’s a paper that addresses the learning curve of the robotic Whipple. It allows us to recognize how many cases a surgeon needs [to do] in order to optimize his or her outcomes. We looked at our first 200 [cases of ] robotic pancreatoduodenectomy. For metrics like conversion and blood loss, the learning curve was short, at about 40 cases. For operative times, we found the learning curve to be approximately 80 cases, due to the continuous modifications we made to the technique throughout the experience. We believe this learning curve will be shorter for new adopters of this platform if a robust training curriculum and adequate mentorship are available. In terms of outcomes, the pancreatic fistula rate decreased

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

significantly after 40 cases. Length of stay and complications also decreased, but this drop was not significant. This may be due to an underpowered sample size, and we hope these numbers become more clinically meaningful with larger series.

Importantly, more than 80% of the cases were performed for malignant indications, with 41% of cases being done for pancreatic adenocarcinoma. This is a large number of pancreatic cancers and implies that if the robotic Whipple is implemented in a safe and thoughtful way by surgeons experienced in pancreatic surgery, the outcomes are just as good as the open operation.

Additionally, it was quite interesting to find that our robotic Whipple learning curve of 80 cases was roughly similar to the open learning curve reported by others from MD Anderson [Cancer Center] and Indiana University, implying that there is some inherent similarity between the open and robotic approaches since they both rely on stereotactic vision, wristed instruments and relatively straightforward ergonomics.

It’s important to note that we employed a two-attending approach in performing these early Whipples and the majority of our early distal pancreatectomies. We thought this was essential for safety early on. I think this is why our safety data are comparable and maybe even slightly better than other centers trying to implement

new technology to complex procedures.

This learning curve is also dependent on a high volume of cases. It will be difficult for a program to implement robotic Whipples if they are doing one case every few months. The learning curve is predicated on continuous improvement of robotic skills.

GSN:: Mortality is a major concern with complex HPB surgery. What does the data show with regard to mortality after robotic Whipple?

Dr. Zureikat: Mortality for robotic Whipple in our series is within the national average. The mortality rate for an open Whipple performed by high-volume surgeons should be under 2%. Our 30-day mortality rate for robotic Whipple was 1.5%. So in the hands of experienced pancreatic surgeons at high-volume institutions, the robotic Whipple mortality and morbidity is on par with the national average. Even early in our experience, the mortality rate was consistently low. This was a direct result of the careful and thoughtful approach with which we implemented our robotic pancreas [surgery] program. We had two attendings doing these robotic Whipples together to ensure that the case proceeds safely. Some reports of increased morbidity and mortality following robotic Whipples are concerning, but they are a direct consequence of lack of careful planning and experience.

‘A surgeon who is not experienced in open HPB or minimally invasive surgery should not be venturing into robotic HPB procedures without adequate training and mentorship.’

—Amer H. Zureikat, MD

A surgeon who is not experienced in open HPB or minimally invasive surgery should not be venturing into robotic HPB procedures without adequate training and mentorship.

GSN:: We see a great deal of marketing from hospitals advertising that they offer the robot, including in HPB surgery.

There are ads online that claim the robot offers advantages in HPB, including an ability to start chemotherapy earlier. What does the published data show?

Dr. Zureikat: Our experience and that of others would say that that’s true: You can start chemotherapy earlier. But a recently published article in the Journal of Clinical Oncologyy that examined nearly 1,000 patients previously enrolled in the prospective ESPC-3 trial stipulated that it’s not the time to chemotherapy that matters, but the ability to complete all doses of the chemotherapy (J ( Clin Oncol 2014;32:504-512) 2 . A recent retrospective report from Mayo Clinic showed that patients who underwent a laparoscopic Whipple started adjuvant chemotherapy earlier than their open counterparts; however, overall survival was the same for both groups ((J Gastrointest Surgg 2015;19:189194). Certainly, in our data—and this is purely retrospective and likely subject to selection bias—more patients get adjuvant chemotherapy after a robotic Whipple. We are currently examining the

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

differences in completion of all scheduled adjuvant chemotherapy for both open and robotic Whipples to determine if there is a survival advantage.

GSN: Are there any advantages to using the robot in HPB? Dr. Zureikat: At the moment, with the data that we have on the learning curve, the one obvious benefit is the reduced blood loss compared with open surgery.

This finding has been confirmed by other groups. Blood loss (and consequently blood transfusion requirements) in cancer surgery is very important, since it is an independent predictor of poor survival. Other advantages have not been well documented, and this is mainly because most surgeons (including our group) were still within their learning curve. Robotic HPB surgery may not show any advantages currently, but these comparisons are premature and uninformative at this stage.

Outcomes of length of stay, morbidity, readmissions, completion of chemotherapy and, ultimately, survival can be formally assessed after the learning curve is achieved. At the University of Pittsburgh, we are in a unique situation to start looking at these outcomes carefully, since we believe the learning curve has been identified and surmounted.

GSN:: What about disadvantages?

There were some concerns about potential to increase fistula rates with robotic surgery.

Dr. Zureikat: We classify our fistulas by International Study Group for Pancreatic Fistula (ISGPF) criteria. The rate of fistula for open Whipples is anywhere between 10% to 25%. After our initial 40 cases, our fistula rate is within the national reported average at 14%. Importantly, only half of those are clinically significant, ISGPF Class B and C fistulas. These are numbers on par with other major institutions.

I think the only real disadvantage at the moment is cost. All the other metrics are similar to what we see with open surgery: fistula, mortality, morbidity, length of stay.

All these are within the national average, but the cost is certainly higher. We’re currently performing a cost analysis model based on deviations from expected outcomes for open versus robotic Whipples beyond the learning curve. Again, the central issue is completing the learning curve; looking at outcomes for a technology that’s only been available for a decade and comparing that with an operation that’s been around for 80 or 90 years is not appropriate. Now that we’ve identified the learning curve, we are looking to see if cost is reduced with the outcomes we are seeing beyond the learning curve.

GSN:: Are there any last things to point out about robotic HPB? Dr. Zureikat: Robotic surgery is heavily

‘Looking at outcomes for a technology that’s only been available for a decade and comparing that to an operation that’s been around for 80 or 90 years is not appropriate.’

—Amer H. Zureikat, MD advertised and marketed by hospitals and surgeons alike. That may be applicable for

urologic and gynecologic procedures, but we have to be careful about marketing this for HPB surgery. A surgeon must be well experienced in both minimally invasive and open HPB surgery and must have prior experience with less complex robotic procedures, like cholecystectomies, splenectomies and partial gastrectomies before attempting HPB procedures. Additionally, we are in need of specific training modules and curricula for the few surgeons who wish to incorporate complex HPB procedures into their practice. As mentioned earlier, our learning curve was pretty long, but the methodology and results

were sound. In this outcomes-driven era, we advocate that programs interested in implementing this platform seek the advice and guidance of well-established robotic programs. In an effort to reduce the learning curve and avoid unnecessary poor outcomes, we and others have developed a framework to guide new adopters and offer them pearls and pitfalls for these complex operations.

If I were to summarize the role of robotics in HPB, I’d say incorporation of robotics in HPB can be performed at high-volume centers by experienced HPB surgeons in carefully selected patients.

Question the norm.

Do the tools you need exist today?

According to us, the answer is no. But each new device takes us closer.

Zenapro, for instance, is the first hybrid hernia-repair device. A sheet of ultra-lightweight polypropylene mesh surrounded by extracellular matrix, Zenapro gives patients a permanent repair while leaving behind minimal foreign material in the body.

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Opinion HEAVY LIFTING jContinued from page 1

Danish Ramazzini Centre, Aarhus University Hospital, in Aarhus, Denmark, in the online version of Hernia (2015 Jan 6.

[Epub ahead of print]).

No relationship was found between total load lifted per day and the adjusted hazard ratio (HR) for reoperation, except for a marginally increased risk in the group lifting 500 to more than 1,000 kg per day (HR, 1.19; 95% confidence interval [CI], 1.00-1.141). Moreover, investigators found no association between reoperations and the daily frequency of lifting loads weighing more than 20 kg or for hours per day spent walking or standing.

Other small studies examined the effects of work activities on risk for recurrence and reoperation after inguinal hernia repair, but the findings have been inconsistent and inconclusive. This study, the latest in a series from this group of investigators, is the largest examination off this hi relationship. l i hip Using register information, the investigators identified all men born in Denmark between 1938 and 1988 who had a first inguinal hernia repair between

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

1998 and 2008, were between 18 and 65 years old, and were active in the labor market at the time of surgery. The cohort was composed of 34,822 men.

The Danish Hernia Database provided information on repairs and reoperations, and investigators used occupational codes and a job exposure matrix based on expert ratings to estimate total load lifted per day, frequency of heavy lifting, and hours per day spent walking and standing.

The study showed that postoperative sickness absence was associated with increased mechanical exposure at work. In turn, prolonged postoperative absence from work was associated with an increased likelihood of reoperation. However, investigators said the prolonged absence from work was “not an intermediate step between high exposures and reoperations,” meaning the absence from work could not be explained by exposure-related complications that led to reoperation.

“Occupational mechanical exposures mayy be b a risk i k factor f off developing d l pi g indii di rect (lateral) inguinal hernia, but it is not a risk factor of reoperation,” Dr. Vad said in an email.

Guy Voeller, MD, professor of surgery

‘The topic remains controversial, especially considering the fact that weightlifters or obese patients do not seem to have an excessive incidence of inguinal hernias.’

—Robert J. Fitzgibbons Jr., MD

at the University of Tennessee Health Science Center, Memphis, said it is difficult to draw any conclusions from the study. Hernia recurrences are caused by multiple factors, he noted, and the design of the study made it difficult to evaluate causes of recurrence.

“In my mind, hernia recurrence wasn’t actually quantified, rather reoperations.

In regard to actual hernia recurrence, I think postoperative lifting is probably a minor reason for recurrence and more important factors exist that could lead to recurrence, like surgical technique, patient [body mass index], size of hernia at index operation, smoking, diabetes mellitus and other comorbidities that were not factored into this analysis.”

Dr. Vad’s team has conducted a series of studies looking at the contentious issue of whether heavy lifting increases risk for inguinal hernia. In 2012, they published a systematic review that found no evidence that occasional heavy lifting, repeated occupational strain or a single strenuous lifting episode resulted in a gr groin hernia (Scand J Work Environ H Heallth 2013;39:5-26), a finding that has con nsiderable bearing on workers’ comp pen nsation and other medicolegal issues,, exxplained Robert J. Fitzgibbons Jr., M MD,, Harry E. Stuckenhoff Professor of Surgery S at Creighton University Sch hoool of Medicine, in Omaha, and a co-eedittor of Hernia.

Soon after, the rreseearchers conducted a population-based coh hort study of nearly 1.5 million patien nts with inguinal hernias that showed th hat first-time inguinal hernia repairs for indiirect inguinal hernias, but not directt heernias, were related to frequent heavy liftting and prolonged standing or walkking at work (Occup Environ Medd 20112;69:802-809).

“The topic rem mains controversial, especially conssideering the fact that weightlifters or obese patients do not seem tto have an excessive incidence of inguinal hernias,” Dr. Fitzgiibbons said.

Curren nt Danish D and European gu uideelines recommend immediiatee return to work by pattien nts after uncomplicateed surgery unless restriicteed by pain. The investiggators said their find dinggs contribute to thee ““evidence for the safetyy of this advice.”

HERNIA MEETING jcontinued from page 1

from friends, scientists, surgeons and researchers from around the world. It was also a huge challenge to consider and consolidate the goals of all five international societies with all the logistical challenges faced by a congress of this size.

The scientific program will include the usual scientific and technical research, and it will also address the specific challenges that surgeons who are interested in this type of pathology face on a daily basis, and include the most current input from manufacturers of the materials and the equipment in this field.

The schedule ... will provide thorough and innovative insights into best surgical practices, and will address the realworld challenges of the vast majority of surgeons all over the world.

The schedule is tight and packed, and will provide thorough and innovative insights into best surgical practices, and will address the real-world challenges of the vast majority of the surgeons all over the world.

All voices will be heard, whether they come from the most modern surgical centers or from surgical centers that are less technically advanced.

Some of the principal questions that inspired the scientific program were: “Is the reality more real than science?” And “Simplify the life of surgeons, simplify the life of patients.” And finally, “Every person carries his or her own burden.”

Besides the scientific program, surgeons will be able to take in the hospitality and culture of Milan. Our social program, organized specifically outside the working time, will be of great interest to attendees and includes the official congress dinner.

Many voices will be heard; many debates will take place; many different opinions, cultures, mentalities, habits and ways of life will come together. But in Milan this year, we all have one common objective: the well-being of the patient.

I look forward to meeting you all very soon.

—Dr. Campanelli, from Varese, — Italy, is the chairman of the 1st World Conference on Abdominal Wall Hernia Surgery and president-elect of the European Hernia Society.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / APRIL 2015

MICROBIOTA

jContinued from page 7 With a catheter-tipped syringe connected to the accessory channel of the colonoscope, he administers 300 mL into the ascending colon, or terminal ileum if easily intubated.

Colleen Kelly, MD, clinical assistant professor of medicine at Brown University, in Providence, R.I., also administers FMT during colonoscopy in patients who are healthy enough to undergo the procedure and who have not had a recent colonoscopy. Otherwise, she uses flexible sigmoidoscopy to place the stool. “It’s a less-invasive procedure and, in my opinion, works as well as colonoscopy,” she said.

process,” Dr. Kelly said. They began in 2013 and have now sent more than 1,000 doses to more than 100 sites, including some to providers who don’t perform FMT often enough to establish a donorscreening protocol, she said.

OpenBiome charges a user fee of $250 per dose, significantly less than the cost of donor screening, which can run to $1,000 or more. “They’ve been really successful in helping providers and researchers. I think their hope is to help people who want to do FMT research obtain materials for their study,” Dr. Kelly said.

Researchers are already looking into

FMT as a treatment for various gastrointestinal disorders; several papers were presented at Digestive Disease Week 2014.

Dr. Brandt said researchers are interested in the technique’s potential to treat conditions unrelated to the gastric tract.

“Insulin resistance, obesity, Parkinson’s, multiple sclerosis, autism: There are bits of scattered data out there that suggest there may be something to this,” he said.

Fecal transplant, however, is only the first step in the probiotic journey. “People have used frozen fresh material, an extract of stool that it is added to water and diluted; it has exactly the same effect

as [fresh] feces,” Dr. Brandt said. A small study showed that a mixture of 33 strains of bacteria derived from normal stool and synthesized into a “living liquor” was able to cure patients of recurrent CDI. “And then there are the poop pills in Canada, 27 to 34 pills [each] that cured them of their disease,” he said.

“So we’re now looking at stool and at different types of derived preparations.

We start with a lot [of bacterial strains], we then go to a few, we may soon even go to a single strain, and perhaps one day we won’t even give the bacteria, maybe just the metabolic products of those bacteria.”

Increasing Popularity Dr. Kelly has seen a definite change in the degree to which FMT is now being offered for CDI, particularly since the publication of a landmark paper that demonstrated a response rate of 82% in patients with CDI who received a nasoduodenal infusion of stool, compared with 31% in those who received vancomycin alone (N Engl J Medd 2013;368:407-415).

“That changed a lot of people’s minds,” Dr. Kelly said. “That, and the FDA’s decision to enact a policy of enforcement discretion last summer.”

The FDA had formerly required investigational new drug permission for anyone using stool as a treatment. “That really put the kibosh on the use of FMT,” Dr. Brandt said. “So we had a public workshop, made impassioned speeches, a couple of our patients made impassioned speeches, and then in July [2013], the FDA said that for CDI that does not respond to standard therapy, they will exercise enforcement discretion. They are not going to come after you as long as you give the patient adequate informed consent, tell them that this is an experimental investigative therapy and explain the potential risks.”

Dr. Brandt added that he was thrilled and impressed with the FDA because the agency changed the direction of its policy in response to public sentiment, which was bolstered by the positive experiences with FMT to date.

In addition to The New England Journal of Medicinee article and the FDA’s enforcement discretion policy, a couple of other developments evolved last year to help expand the use and investigation of FMT. One is the Fecal Transplant Foundation, a website started by a patient. The site contains a list of FMT providers in both the United States and abroad.

OpenBiome Another is the nonprofit OpenBiome, a stool bank developed by a group of researchers from MIT. “OpenBiome recruits donors, screens the stool and centralizes the whole

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