The 2012 Digital Edition of General Surgery News Special Edition

The Independent Newspaper for the General Surgeon

INTERNATIONAL EDITION

Volume 1 • 2012 GENERALSURGERYNEWS.COM

40th ANNIVERSARY YEAR 1972-2012

Breast Cancer Susceptibility Gene Identified B Y G EORGE O CHOA

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n international team of researchers has identified a new breast cancer susceptibility gene, XRCC2 ((Am J Hum Genett 2012;90:734-739).

In an interview, senior author Melissa C. Southey, PhD, Grad Dip Law, FHGSA, FFSc (RCPA), professorial fellow and head of Genetic Epidemiology Laboratory, and group leader at the Victorian Breast Cancer Research Consortium, National Health and Medical Research Council, Australia, stated, “We found a gene that when mutated predisposes to breast cancer, and this adds to the small collection of breast cancer susceptibility genes previously identified.”

By exome sequencing families with multiple individuals affected by breast cancer, the researchers identified two families with XRCC2 mutations. Subsequently, two further studies were conducted: One a population-based case-control mutation screening study of XRCC2 and the other additional mutation screening of XRCC2 in index cases from multiple-case families and in male breast cancer cases. The researchers identified six distinct rare variants in the gene that were predicted to see GENE page 8

REPORT Technological Advancements in Tissue-Sealing Devices See insert at page 6

Controversy Swirls Over Efficacy and Safety of Procedure for Acalashia

®

Study Tracks Pain 10 Years After Open Hernia Repair Proper Nerve Handling the Key

POEM Procedure Shows Promise, As Experts Urge Caution B Y C HRISTINA F RANGOU B Y C HRISTINA F RANGOU SAN DIEGO—A new endoscopic therapy for achalasia has been dubbed a “promising new treatment” that could rival conventional methods, after a series of reports from Asia, Europe and North America indicated that peroral endoscopic myotomy (POEM) is safe and effective.

Speaking at Digestive Disease Week 2012, Horst Neuhaus, MD, said, “[POEM] promises to be as effective as laparoscopic myotomy or pneumatic dilation.” Dr. Neuhaus, professor of medicine and head of internal medicine, Evangelisches Krankenhaus Düsseldorf Teaching Hospital of the University

see POEM page 26

Surgeons Discuss Bariatric Options For GERD and Hiatal Hernias Optimal Approach in Some Patients; Insurance Challenge B Y M ONICA J. S MITH SAN DIEGO—Should bariatric surgery be a part of treatment options for gastroesophageal reflux disease (GERD) and/or large hiatal hernias in obese patients?

“Yes!” said Jon C. Gould, MD, emphatically, at the 2012 meeting

of the American Society of Gastrointestinal and Endoscopic Surgeons (SAGES).

Dr. Gould, associate professor of surgery, Medical College of Wisconsin and chief, Division of General Surgery, Froedtert Hospital, Milwaukee, specializes in bariatric surgery, but a large part of his practice is foregut

NEW YORK K—One in six patients who reported chronic pain six months after an open inguinal hernia repair still suffers from chronic pain 10 years later, according to a prospective German study reported at the Fifth International Hernia Congress. Others develop late-onset pain, even after five years.

“Patients reporting chronic pain vary with time. This is a very important message,” said lead author Wolfgang Reinpold, MD, director of the Department of surgery of Gross Sand Hospital and director of the Hernia Center, Hamburg, Germany.

The study was initially published in Annals of Surgery in 2011, at which point, only five-year data were available. At this spring’s international hernia meeting, Dr. Reinpold presented updated results after conducting a 10-year follow-up of the prospective two-phase study. The prospective cohort study followed 736 patients who underwent 781 elective primary inguinal hernia operations at the Hernia Centre of Reinbek Hospital, Germany, from April 2000 to April 2002. Patients underwent pain see HERNIA REPAIR PAIN page 10

REPORT Benefits of GORE® DUALMESH® Biomaterial in Hernia Repair: A Case-based Presentation

see GERD AND HERNIA page 12

See insert at page 14

INSIDE Opinion

In the News

The Surgeons’ Lounge: Hernia and Epiphrenic Diverticula. ........................ 6

International Fellowship Program in Laparoscopic Colorectal Surgery......... 18

New App Predicts Chronic Pain After Inguinal Hernia Surgery ............................ 20

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From the Editors

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS INTERNATIONAL EDITION 2012

Dear Reader, General Surgery Newss is pleased to present its first international issue, and welcome you as our reader. The vision for this edition emerged after speaking with several surgeons about the need for comprehensive coverage of surgery news from around the world.

This issue includes news and feature articles, as well as expert opinions focused on clinical and technological innovations in a range of areas, including hernia repair, breast cancer and bariatric surgery. Many of the pieces highlight clinical research done by surgeons worldwide.

Included within these pages is an article that discusses the controversy over the safety and efficacy of peroral endoscopic myotomy (POEM), research that examines chronic pain after inguinal hernia repair and an article exploring how surgeons are changing their practice after the Z0011 data were published last year.

The issue also contains a section called The Surgeons’ Lounge in which surgeons tackle case-based questions submitted by readers. In this section, surgeons from the United Kingdom discuss a patient with a complex abdominal wall hernia, and a surgeon from Israel explains his surgical approach to epiphrenic diverticula. We hope that you enjoy reading this edition and the topics featured here engender a lively discussion and debate. We look forward to any and all comments and feedback (please find enclosed survey), and we hope this is the first of many issues to come.

Sincerely, The Editors, Kevin Horty khorty@mcmahonmed.com Victoria Stern

The staff of General Surgery News at the office in New York City. From left, Victoria Stern (Associate Editor), Michael Enright (Publication Director), Deanna Cosme (Art Director), Kevin Horty (Group Publication Editor) and Kate Carmody (Manager of Publication Sales).

Senior Medical Adviser Frederick L. Greene, MD Charlotte, NC General Surgery, Laparoscopy, Surgical Oncology

Editorial Advisory Board Maurice E. Arregui, MD Indianapolis, IN General Surgery, Laparoscopy, Surgical Oncology, Ultrasound, Endoscopy

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

Philip S. Barie, MD, MBA New York, NY Critical Care/Trauma, Surgical Infection

L.D. Britt, MD, MPH Norfolk, VA General Surgery, Trauma/Critical Care

David Earle, MD Springfield, MA General Surgery, Laparoscopy

James Forrest Calland, MD Philadelphia, PA General Surgery, Trauma Surgery

Edward Felix, MD Fresno, CA General Surgery, Laparoscopy

Robert J. Fitzgibbons Jr., MD Omaha, NE General Surgery, Laparoscopy, Surgical Oncology

David R. Flum, MD, MPH Seattle, WA General Surgery, Outcomes Research

Michael Goldfarb, MD

Leo A. Gordon, MD Los Angeles, CA General Surgery, Laparoscopy, Surgical Education

Gary Hoffman, MD Los Angeles, CA Colorectal Surgery

Namir Katkhouda, MD Los Angeles, CA Laparoscopy

Joseph J. Pietrafitta, MD

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Š 2012 by McMahon Publishing, New York, NY 10036. All rights reserved. General Surgery News (ISSN 1099-4122) is published monthly by McMAHON PUBLISHING, Sales, Production and Editorial Offices: 545 W. 45th St., 8th Floor, New York, NY 10036, Tel. (212) 957-5300. Corporate Office: 83 Peaceable St. West Redding, CT 06896. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Please send address changes to General Surgery News, 545 W. 45th St., 8th Floor, New York, NY 10036.

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Mission Statement It is the mission of General Surgery News to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons.

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INFECTIOUS DISEASE SPECIAL EDITION

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS INTERNATIONAL EDITION 2012

Study Offers Glimpse on How Surgeons Are Applying Z0011 Data B Y M ONICA S MITH PHOENIX X—After results of the American College of Surgeons Oncology Group’s ACOSOG Z0011 trial were released— first the local recurrence data in 2010 ( (JAMA A 2011;305:569-575) and then the survival data in April 2011 at a meeting of the American Surgical Association— it has been unclear how the trial’s findings have influenced practice. Research

presented at the annual meeting of the American Society of Breast Surgeons shows that surgeons at one large institution have grown increasingly comfortable applying the Z0011 data to their patients ((Ann Surg Onc; July 2012, Epub ahead of print).

In August 2010, the University of Texas MD Anderson Cancer Center, in Houston, assembled a multidisciplinary team of surgeons, radiation oncologists, pathologists and medical oncologists to

determine how to use the Z0011 findings, that showed no difference in local recurrence or survival between selected patients with positive sentinel lymph nodes (SLN) who omitted axillary lymph node dissection (ALND) and patients who underwent ALND. “We discussed the results of the trial and the relevant literature and came up with a group consensus on how to apply this data in our clinical practice,” said Abigail S. Caudle, MD, assistant professor of

surgical oncology at MD Anderson Cancer Center.

Subsequently, Dr. Caudle and colleagues sought to determine the impact of Z0011 on surgeon practice patterns, and to see which patients’ surgeons seemed most comfortable applying the data. The retrospective review involved 17 surgeons and two cohorts of patients: those seen in the year before the release of Z0011 and those seen in a 12-month period after their interdisciplinaryy conference. The investigators used only patients who met eligibility criteria for Z0011, excluding those who had neoadjuvant chemotherapy, those who underwent mastectomy and those with tumors larger than 5 cm on surgical pathology.

The investigators included 658 patients: 335 in the pre-Z0011 results group, of whom 62 (19%) were SLN-positive, and 323 in the post-Z0011 results group, of whom 42 (13%) were SLN-positive.

In the pre-Z0011 cohort, 85% of SLNpositive patients underwent ALND, compared with 24% of those in the postZ0011 cohort. Given that the proportion of post-Z0011 patients undergoing ALND dropped from 28% in the first six months of the post-Z0011 time frame to 18% in the subsequent six months suggests that surgeons became more

It has been unclear how the trial’s findings have influenced practice. comfortable applying the Z0011 data over time.

One purpose of this study was to determine if there were patient groups to which surgeons were not applying Z0011 data, and how they were distinguishing those patients. “In the pre-Z0011 group, the decision to omit ALND appears to be driven by SLN characteristics, while in the post-Z0011 group, the decision to perform ALND appears to be driven by primary tumor features,” Dr. Caudle said.

In the post-Z0011 cohort, surgeons were more likely to perform ALND on patients who had larger tumors, lobular histology, fewer SLNs retrieved, larger SLN metastasis, evidence of extranodal extension, and those in whom a validated nomogram predicted a higher probability of positive non-SLNs. The researchers also examined the impact of Z0011 on adjuvant therapy and found that the radiation oncologists at

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS INTERNATIONAL EDITION 2012

‘This was definitely a wellreceived paper. I think it’s always important for people to hear that the big institutions have accepted and altered their practice based on the findings.’ —Judy Boughey, MD

metastasis—the more worrisome cases,� Dr. Boughey added. “It is also important to note that the findings are not being extrapolated to women undergoing mastectomy, or receiving partial breast radiation or neoadjuvant chemotherapy.�

Dr. Boughey also noted the inclusion of intraoperative nodal assessment and its impact on operating time. “In this day and age, people are more in tune with trying to cut down on unnecessary additive costs if it doesn’t

benefit the patient or alter the patient’s treatment; decreased intraoperative assessment lowers cost and allows shorter operating time for the patient.�

In her practice, Dr. Boughey said she and her colleagues still perform frozen section analyses on all SLNs. In particular, it remains important for surgeons to perform intraoperative analysis of SLNs when they encounter a node that they are concerned will be positive by palpation because it’s more likely that there will be several additional positive nodes. “But, in nodes you think will be negative, I think it’s reasonable not to do

intraoperative nodal assessment in those cases where the patient meets Z0011 criteria, is undergoing breast conservation, doesn’t have a very large tumor and didn’t have neoadjuvant chemotherapy, if you plan not to do a dissection in node-positive cases,� she said.

Drs. Boughey and Caudle had no relevant disclosures.

khorty@mcmahonmed.com.

Move beyond to the next generation.

MD Anderson had been adjusting radiation fields to add high tangents for those who do not undergo ALND. “In the pre-Z0011 cohort, 10% had high tangents versus 43% in the postZ011 cohort,� Dr. Caudle said. “We feel that this is a reflection of changing surgical practices, since only 2% of patients who underwent ALND had high tangents compared with 88% who did not have an ALND.�

They also found that surgeons were less likely to perform intraoperative nodal assessment in the post-Z0011 cohort; assessment fell from 69% in the pre-Z0011 cohort to 26% in the postZ0011 group. This change led to a decrease in operative time, from a median of 92 down to 79 minutes. “This was definitely a well-received paper,� said Judy Boughey, MD, associate professor of surgery, Mayo Clinic, in Rochester, Minn. “I think it’s always important for people to hear that the big institutions have accepted and altered their practice based on the findings. In particular, people are interested in how surgeons and institutions have incorporated the study findings into their everyday clinical practice. “One of the critical things this abstract showed was that it is still a limited proportion of patients you see who fit the exact criteria for Z0011. Surgeons are more likely to do dissections for patients with larger tumors, fewer SLN removed or larger lymph node

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Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS INTERNATIONAL EDITION 2012

Dear Readers, Welcome to the The Surgeons’ Loungee with experts from our International Series. This issue features David Hazzan, MD, director of minimally invasive surgery, Carmel Medical Center in Haifa, Israel, who will be discussing the case of epiphrenic diverticula. The issue also includes Steve Hornby, BMBS, MRCS, upper GI clinical research fellow, General Surgical Registrar in the South Peninsula, and director of education for the Association of Surgeons in Training, London, and Andrew Kingsnorth, MD, consultant surgeon and honorary professor of surgery at the Peninsula College of Medicine and Dentistry, president of the surgical section of the Royal Society of Medicine, and past president of the European Hernia Society and the British Hernia Society, London, who have prepared a detailed case report of a patient with an abdominal wall hernia and describe here how they managed this very complex case. I want to give special mention to commander Rory Rickard, MD, a consultant plastic and reconstructive surgeon based in London.

We look forward to your comments and questions.

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

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 Dr. Hazzan From Tamar Abramovich, MD Department of Surgery B, Carmel Medical Center, Haifa, Israel

A

68-year-old woman had a history of regurgitation, halitosis and recurrent aspirations over the past few years. She underwent a barium swallow that revealed epiphrenic esophageal diverticula. What is your preferred workup for this patient? Do you always perform a preoperative manometry? Are asymptomatic patients candidates for surgery? What is the likelihood of malignancy in the diverticula? What is your preferred surgical approach?

Figure. Epiphrenic esophageal diverticula seen on barium swallow.

Dr. Hazzan’s

Reply

Epiphrenic diverticula are found adjacent to the diaphragm in the distal third of the esophagus. They are false diverticula that often are related to achalasia and diffuse esophageal spasm. They most often are related to thickened esophageal musculature or increased intraluminal pressure.

A barium swallow is the best diagnostic tool to detect the presence of

epiphrenic diverticula. The size, position and proximity of the diverticula to the diaphragm can be clearly delineated. The underlying motility disorder often is identified as well; however, manometric studies need to be undertaken to evaluate the overall motility of the esophageal body and lower esophageal sphincter. An endoscopy is always performed to detect mucosal lesions, including esophagitis, Barrett’s esophagus and distal cancer.

Treatment is recommended for patients who have moderate to severe symptoms. There is no consensus as to whether asymptomatic patients

should undergo treatment as well.

Despite the finding that asymptomatic patients do not usually develop symptoms during many years of follow-up, the fact that minimally invasive approaches are available for the management of epiphrenic diverticula may make surgical therapy more appealing.

The incidence of cancer in an epiphrenic diverticulum is less than 1%. Risk factors for malignancy are advanced age, male gender, longstanding history of cancer and larger diverticula. Outcomes usually are quoted as dismal because of a delayed diagnosis but several cases of superficial carcinoma have been described.

In this particular case, because the diverticulum is wide-mouthed, I would perform a diverticulectomy, contralateral myotomy and Toupet fundoplication. In some cases when the diverticulum is small, surgeons might recommend diverticulopexy to prevent creating a stapler line that is at risk for leakage. In both cases, a long esophageal myotomy is a crucial step in the treatment of this pathology. The extent of the myotomy is an iissue off d debate: b t M Mostt authors th recommend starting from the level of the base of the diverticulum and extending the myotomy 1 to 2 cm distal to the esophagogastric junction.

For many decades, the traditional approach was through a left thoracotomy; more recently, minimally invasive techniques by video-assisted thoracic surgery or laparoscopy have been used successfully and are now the procedures of choice in most cases. I strongly believe that the laparoscopic approach is ideal for the treatment of this pathology. The esophageal hiatus is approached, the distal esophagus is mobilized and the diverticula is identified and cleared of surrounding

tissue to expose the mucosa at the neck of the diverticula. After inserting a 56 to 60 Fr bougie down through the esophagus, a linear cutting stapler is used to excise the diverticula. The overlying muscle is closed. A myotomy is then performed on the opposite side of the esophagus, the hiatus is closed and a partial fundoplication— either Dor or Toupet—is performed.

The postoperative morbidity should be less than 5%. Most patients can be discharged by postoperative day 2 and the long-term results in terms of dysphagia or reflux are similar to those of patients after Heller myotomy due to achalasia.

Suggested Reading 1.

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Vicentine FP, Herbella FA, Silva LC, Patti MG. High resolution manometry findings in patients with esophageal epiphrenic diverticula. Am Surg. 2011;77:1661-1664.

Fisichella PM, Pittman M, Kuo PC. Laparoscopic treatment of epiphrenic diverticula: preoperative evaluation and surgical technique. How I do it. J Gastrointest Surg..

2011;15:1866-1871.

Zaninotto G et al. Therapeutic strategies for epiphrenic diverticula: systematic review. World J Surg. 2011;35:1447-1453.

Rosati R et al. Long-term results of miniimally ll iinvasive i surgery ffor symptomatt t ic epiphrenic diverticulum. Am J Surg.

2011;201:132-135.

D’Journo XB et al. Lower oesophageal sphincter dysfunction is part of the functional abnormality in epiphrenic diverticulum. Br J Surg. 2009;96:892-900.

Melman L et al. Esophageal manometric characteristics and outcomes for laparoscopic esophageal diverticulectomy, myotomy, and partial fundoplication for epiphrenic diverticula. Surg Endosc.

2009;23:1337-1341.

Varghese TK Jr et al. Surgical treatment of epiphrenic diverticula: a 30-year experience. Ann Thorac Surg. 2007;84:1801-1809.

Reznik SI et al. Assessment of a pathophysiology-directed treatment for symptomatic epiphrenic diverticulum. Dis Esophagus. 2007;20:320-327.

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS INTERNATIONAL EDITION 2012

Case Study of a Difficult Hernia

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62-year-old man presents as a national referral to your specialist complex hernia clinic. He has massive lower abdominal wall herniation. The patient was initially treated several years ago for bilateral inguinal hernias and since then has had at least five attempts to repair recurrences. A variety of mesh materials and tissue planes have been used, including laparoscopic approaches.

On physical examination, the entire abdominal wall below the umbilicus is affected, and with the patient in standing position, the hernia reaches his knees (Figures 1 and 2). With the patient in lying position, the hernia appears to be completely reducible, and several of the previously implanted meshes are palpable.

It appears from the examination and the evidence provided from a magnetic resonance imaging (MRI) scan that the right inguinal ligament is destroyed.

This patient’s quality of life is so adversely affected by his hernia that he is desperate for a further attempt at repair.

How is this complex problem managed?

Andrew Kingsnorth, MD

Mr. Steve Hornby

Description of Case Management A key first step in patients such is this one is to manage their expectations. This patient should be informed that the risk for further failure of the repair is approximately 50% and that there would be a significant risk for mortality associated with a reconstruction of this scale. The patient is not overweight, but if he were, he would be strongly advised to lose weight and, if necessary, referred to a specialized dietetic team.

Given the high likelihood he will require tissue replacement of the inguinal ligaments, it is recommended he receive the help of a specialist plastic surgeon. A theater (operating room) slot of at least eight hours should be set aside.

The patient was taken to theater with two consultant surgeons specializing in abdominal wall reconstruction, a herniologist and a plastic surgeon. The operation required six hours and 40 minutes to complete. On opening the redundant skin, several large pieces of mesh were found and excised (Figure 3).

The abdominal wall consisted of only atrophied rectus abdominis muscles about 2 cm wide, and the right inguinal ligament was absent. The redundant skin was excised and adhesiolysis was performed. The right inguinal ligament was reconstructed by mobilizing a strip of rectus femoris fascia and securing it using nonabsorbable sutures between the anterior superior iliac spine and the pubic tubercle (Figure 4).

When completed, this reconstruction was used as a platform to place an underlapping biological mesh to close the hernia defect (Figure 5). This region was further reinforced with an onlay polypropylene mesh (Figure 6). Both meshes were affixed with a

nonabsorbable suture. Drains were placed on top of the mesh with instructions not to remove for five days and to only drain less than 50 mL every 24 hours.

The patient initially had an unstable recovery. He developed pulmonary edema and right lower lobe collapse, and required a two-day intensive care unit admission for noninvasive ventilation. After these issues were dealt with, recovery was steady and he was discharged on day 13 postsurgery.

The patient has been followed up for nine months.

At this stage, he has complained of several aches and pains as well as gastroesophageal reflux, but his hernia repair remains intact and this has been confirmed on MRI scan (Figures 7 and 8).

In summary, here are several points to consider when treating this patient: • Multidisciplinary teamwork: This patient benefited from specialist care by a hernia surgeon, a plastic surgeon, an anesthetist, an intensivist, physiotherapists and nursing staff, all of whom had roles to play in his repair and recovery • Considered use of mesh • Biological mesh for tissue reconstruction • Synthetic mesh for reinforcement and strength • Drain management: The drains in our cases are left until the postsurgical collection is drained to dryness. Seromas remain an unsolved problem, but the use of tissue glues and talc products may offer solutions Autologous tissue repair techniques, such as the components separation and rectus femoris fascia flaps, should be in the armamentarium of any surgeon tackling these complex reconstructions.

Figure 1. Front view.

Figure 3. Previous mesh material.

Figure 5. Biological mesh.

Figure 7. Postoperative follow-up, front view.

Figure 2. Side view.

Figure 4. Rectus femoris fascia reconstruction.

Figure 6. Synthetic mesh.

Figure 8. Postoperative follow-up, side view.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS INTERNATIONAL EDITION 2012

Nasal MRSA a Risk Factor for Post-op Surgical Site Infections First Study To Document Link in Gastrointestinal Surgery B Y D AVID W ILD SAN DIEGO—Preoperative methicillin-resistant Staphylococcus aureus (MRSA) colonization increases the risk for surgical site infections (SSIs) and increases hospital length of stay (LOS) following major gastrointestinal (GI) surgery, according to a study presented at the 2012 Digestive Diseases Week. Investigators said the results may justify a policy of universal preoperative nasal swabbing and MRSA decolonization.

“Preoperative nasal swab testing with decolonization of MRSA-positive patients could decrease lengths of stay and reduce the incidence of MRSA-associated SSI after major gastrointestinal surgery,” said lead researcher Harry Papaconstantinou, MD, who is chief of colorectal surgery at Scott and White Memorial Hospital, in Temple, Texas.

Dr. Papaconstantinou and colleagues conducted nasal swab tests for MRSA and methicillin-sensitive S. aureus (MSSA) in 1,137 patients who underwent major GI surgery between December 2007 and August 2009 (abstract 374). Patients were swabbed within 48 hours of hospital admission. Swabs showed 6.4% (73 patients) were MRSA-positive, 14.7% (167) were MSSA-positive and 78.9% (897) were S. aureus-negative on admission. Demographic traits of the three groups were similar.

The researchers found 13.7% (10) of MRSA-positive patients developed an SSI, compared with 4.2% (seven) of MSSA-positive patients and 9.4% (84) of uninfected patients (P<0.05 for MRSA vs. MSSA and uninfected).

Patients with SSIs (aggregated across MRSA,

GENE

jContinued from page 1 severely affect protein function: Two of these variants were protein-truncating mutations and four resulted in missense changes.

Dr. Southey, also senior research fellow and deputy head in the Department of Pathology, University of Melbourne, Australia, said the study would be relevant to “clinical oncologists who work with families with multiple cases of breast cancer. This is another gene they can test for.”

No commercially available tests have yet been developed based on these findings; however, Dr. Southey said, “I imagine there will be [tests] soon, to help women determine their personal risk for breast cancer. Some treatment choices might be influenced by knowing if a woman has a mutation in XRCC2.”

In the paper, the researchers noted that specific targeted treatments such as poly(ADP-ribose) polymerase (PARP) inhibitors might benefit patients whose breast cancer is associated with

‘The question remains as to what is the best course of preventive action.’

—Philip S. Barie, MD, MBA

homologous-recombination DNA repair dysfunction, as is the case with deleterious XRCC2 mutations.

The study is the first report of massively parallel sequencing being used in the discovery of a breast cancer susceptibility gene, said Dr. Southey, who called this “one of the really exciting things about this paper.” She added, “We anticipate finding more genes related to susceptibility to breast cancer by applying this methodology.”

Massively parallel sequencing has been used previously to identify the genetic explanation for relatively simple autosomal-dominant diseases, Dr. Southey stated. “This is the first report applying it to a complex disease. Now the world’s our oyster.” Dr. Southey is currently using the technique to study genetic predisposition to prostate and colorectal cancers. “A large number of genetic research groups are applying this technology.”

MSSA and uninfected groups) had an LOS of 15.7 days, compared with 6.2 days among those with no SSIs (P<0.001). Including individuals with and without SSIs, MRSA-positive patients had significantly longer hospital stays (mean, 12.5 days for MRSA-positive vs. 8.8 and 7.6 days for MSSA-positive and uninfected, respectively; P<0.001). However, when the investigators examined only those with SSIs, they found no significant differences in LOS between patients with wound MRSA colonization and those with MRSAfree SSIs. Mortality rates also did not differ among the three groups, with each approximately 4%.

Dr. Papaconstantinou was surprised that 70% of MRSA-positive patients also had MRSA-positive wound cultures. He said that he expected most post-GI surgery wound pathogens to originate from the gut. In contrast, only 8.5% of patients who had negative nasal swabs had MRSA-positive wound cultures (P<0.0001).

Philip S. Barie, MD, MBA, professor of surgery and professor of public health at Weill Cornell Medical College, in New York City, who was not involved in the study, said that MRSA colonization has been linked to an increased risk for SSIs in cardiac and orthopedic surgery patients ((J Am Acad Orthop Surgg 2012;20:94101). He said that this is the first study to document a link in the GI surgery patient population.

“These findings get the message out that MRSArelated SSIs can occur after a broader spectrum of operations than was previously believed,” Dr. Barie told General Surgery News. “The question remains as to what is the best course of preventive action. This retrospective study makes an important observation, but does not constitute proof that screening and decolonization will be effective before GI surgery.”

Dr. Papaconstantinou had nothing to disclose. Dr. Barie is a consultant to Forest Laboratories, Merck and Pfizer.

‘This is the first report applying it to a complex disease. Now the world’s our oyster.’

—Melissa C. Southey, PhD, Grad Dip Law, FHGSA, FFSc

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS INTERNATIONAL EDITION 2012

New Fixation Technique Cuts Tacks Needed In Hernia Repair May Lessen Postoperative Pain

in place and deposited four tacks into the mesh at cardinal points around the mesh perimeter. They then marked all the spots where they would usually put tacks, leavB Y C HRISTINA F RANGOU ing less than 1 cm between each mark. After marking the exterior and inner ring of the double crown, the surNEW YORK K—Spanish surgeons have reported a new geons placed a tack at every third or every fourth mark method of mesh fixation for laparoscopic ventral her- and filled in the gaps with fibrin glue. Lab studies have nia repair that significantly reduces the number of tacks shown that fibrin glue has a chemotactic effect, increasrequired and may diminish patients’ postoperative pain. ing the collagen, spurring new vessel growth and conThis new technique uses a combination of tacks and sequently causing a biological rather than mechanical fibrin glue placed in a double-crown technique. fixation.

“I think with this study, we have shown the feasibiliIn a series of 38 patients, Dr. Morales-Conde and ty of this technique, which decreases mechanical fixation her team showed they could reduce the number of tacks and should reduce acute and postoperative chronic pain by 66% by using this technique. All patients included without increasing the recurrence rate,” said lead author in the study had primary or secondary ventral hernias, Salvador Morales-Conde, MD, chief of the Advanced located at the midline, far from bones and sizes ranging Laparoscopic Unit of the University Hospital Virgen del between 3×3 and 17×12 cm.

Rocío in Sevilla, Spain. Dr. Morales-Conde presented There were no intraoperative complications; postopthe results at the Fifth Intererative days in the hospital avernational Hernia Congress ‘I think with this study, we have aged 1.62 days with a range of (session 7C abstracts). one to seven. Two patients (5.7%) shown the feasibility of this Previous studies have were readmitted due to paralytic drawn a link between pain ileus. None of the patients reporttechnique, which decreases and the number of tacks (Br ed chronic pain at a median folJ Surg 2011;98:1537-1545), mechanical fixation and should low-up of 24 months. Without a which is why Dr. Morales- reduce acute and postoperative control group, however, the team Conde and her team set out could not demonstrate any changto develop a technique that chronic pain without increasing es in pain compared with standard would reduce the number of fixation techniques. the recurrence rate.’ tacks required. For this techTo date, none of the patients —Salvador Morales-Conde, MD nique, surgeons put the mesh has developed a recurrence after

HERNIA REPAIR PAIN jContinued from page 1

assessments on the day of surgery, the first, second and seventh day postsurgery, and at six months and five years after surgery.

The chronic pain was 16.4% and sensory disorder rate was 15.9% after six months. At the five-year mark, 16.1% of patients reported chronic pain and 20.3% had sensory disorder of the groin.

Independent significant predictors of chronic pain were preoperative pain, chronic pain after six months, sensory disorder after five years and ilioinguinal nerve neurolysis in Lichtenstein repair due to mobilization of the nerve from its natural bed and nerve preservation.

Based on the results of the study, Dr. Reinpold and colleagues called on surgeons to avoid ilioinguinal nerve mobilization in the Lichtenstein technique.

“The inguinal nerves should either be left untouched in their natural bed or if this is not possible a neurrectomy and proximal end implantation … should be performed,” they said.

At the meeting, the investigators presented their 10-year outcomes data.

They had sent a questionnaire to 736 patients, and received responses from 55%. Eight patients in the cohort died

over the course of the study.

Among the respondents, 13.6% reported chronic pain 10 years after surgery. Most patients with pain classified it as mild without an effect on daily activities or quality of life. However, eight patients (1.8%) had relevant pain, defined as a score greater than 3 on the visual analog scale. No patient described the sensation as very strong.

Five of the eight reported a slight interference with daily activities.

Among the eight patients with relevant pain, five had undergone a Lichtenstein repair and three had a Shouldice repair.

Seven of the eight patients had neurolysis of the ilioinguinal nerve with preservation of the nerve.

Significant predictors of chronic pain were younger than age 50 years, sensory disorder of the groin after five years and chronic pain after six months.

Dr. Reinpold said the 10-year results confirm their earlier recommendations.

They called on surgeons to visualize the

a median follow-up of 24 months. One patient was diagnosed with a “tack hernia,” a condition that’s been described in the literature as a fascial defect related to the tack site ((JSLS S 2003;7:383-387).

The Spanish research team is continuing to add to its series. The team currently is using plastic permanent tacks, rather than titanium spiral tacks, in the same technique. The researchers hypothesize that plastic permanent tacks will create less adhesions.

Surgeons who heard the study presented say the technique is promising but longer follow-up with more patients is needed. “We have a long way to go, but this is certainly something to watch,” said Karl LeBlanc, MD, MBA, past president of the American Hernia Society and director and program chair of Fellowship Program, Minimally Invasive Surgery Institute, Baton Rouge, La. One surgeon present questioned the “tack hernia,” saying he felt that it was a form of recurrence. However, both Drs. Morales-Conde and LeBlanc, who first reported on tack hernias, said that it represents a new hernia.

The surgical team is following a watch and wait approach for the tack hernia because it is small and asymptomatic, said Dr. Morales-Conde.

Several groups in Spain and Italy have adopted the new technique but there are no reports of surgeons using it in the United States.

Dr. Morales-Conde reported no relevant disclosures. The glue used in the study is Tissucol (Tisseel in the United States), which is manufactured by Baxter.

nerves and handle with care; to leave the inguinal nerves untouched in their natural bed or, if this is not possible, to perform a neurectomy and proximal end implantation; to leave the cremasteric muscle and spermatic fascia in tact; and to avoid mesh suture fixation to the internal oblique muscle.

The investigators believe that a chronic inflammatory reaction occurs between the conventional polypropylene mesh and mobilized nerve, leading to long-term post-herniorrhaphy chronic pain. Another hypothesis is that chronic scar formation with fibrotic nerve traction leads to chronic pain.

operation and the nerves need to be treated carefully, left in their natural beds and not exposed to contact with the mesh.

“Mesh repair has its own principles that have to be followed. For many years, surgeons had a mindset that was otherwise,” said Parviz K. Amid, MD, clinical professor of surgery, David Geffen School of Medicine at University of California, Los Angeles and director of the Lichtenstein Amid Hernia Clinic at the university.

Dr. Amid said patients persistently hung onto three “cardinal mistakes from the past”: removing the ilioinguinal nerve from its natural bed, roughly mobilizing the spermatic cord by finger instead of doing it gently under direct vision ‘Surgeons are beginning to and removing the cremasteric laythat protect the genital branch understand that they have to ers of the genitofemoral nerve and the deprogram their memory bank and vas deferens. on the current evidence, not rely on teachings of the past.’ theBased rate of chronic pain can be —Paviz K. Amid, MD reduced to less than 1% by careful nerve handling, Dr. Amid Dr. Reinpold’s study comes on the said, and surgeons are growing more heels of international guidelines pub- cognizant of nerve management. “Surlished in 2011. Both reports stress what geons are beginning to understand that some specialists have argued for years: A they have to deprogram their memory mesh repair is not the same as a tradition- bank and not rely on teachings of the al tissue repair with the addition of mesh. past,” said Dr. Amid.

Mesh repairs are a completely different

In the News

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Study Shows Apparent Safety of Biologic Mesh for Hiatal Hernias Conflicts With Earlier Studies; Long-Term Effects Still Uncertain B Y C HRISTINA F RANGOU

A

large single-center series reported no major complications associated with use of biologic mesh to repair large hiatal hernias. This finding contrasts with other recent studies that have shown an increased risk for morbidity related to prosthetic and biologic meshes in these patients.

“Given the potential benefits of biologic mesh, we believe that surgeons who pay careful attention to its placement should feel reassured in the safety of using these meshes during hiatal hernia repair,” wrote Eelco B. Wassenaar, MD, and colleagues from the University of Washington, in Seattle (Surg Endosc 2012;26:1390-1396). They caution, however, that the low complication rate may

reflect their own technique and not that of the general community.

Use of biologic mesh for repair of paraesophageal hernia has been increasing ever since studies showed that, when used to reinforce hiatal closure, these meshes decrease short-term recurrence (Ann ( Surgg 2006;244:481-490). But over the past few years, surgeons reported serious complications following biologic mesh repair, including erosion, dense fibrosis and esophageal stenosis (Surg Endosc 2009;23:1219-1226).

After the 2009 study was published, the research team at the University of Washington decided to review its institution’s experience. The group had used biologic mesh extensively for complicated hernia repair and led the original randomized trial. The study included all patients who had a biologic mesh placed at the hiatus and who were followed for at least one year. The investigators administered a questionnaire to identify any cases

‘This study has long-term followup, which gives us a little bit of breathing room to say that biologic meshes seem to be safe.’

—Emanuele Lo Menzo, MD, PhD

of symptoms of gastroesophageal reflux disease, dysphagia and all other operative or endoscopic interventions that occurred after mesh implantation.

Of 126 eligible patients, 73 (58%) returned a questionnaire. Of those who did not respond, four patients (3%) had died from causes unrelated to the operation, four patients (3%) did not want to participate and 47 patients (36%) were unreachable. The surveyed group had a median follow-up of 45 months.

Surveys showed that no patient reported mesh-related complications and no patient had an erosion, stricture or indication from radiographic or endoscopic evaluation. No patient required a reoperation except one man for recurrent reflux symptoms with a recurrent sliding hiatal hernia.

The surveyed patients reported an overall improvement in all symptoms after their hernia repairs. No restriction or mild restriction in what they could eat was reported by 89% of patients. Twothirds of patients graded their operative result as “excellent,” 23% as “good,” 6% as “fair” and 5% as “poor.” Among patients with poor results, one experienced severe dysphagia, one was dissatisfied with postoperative follow-up but did not have any symptoms, and another had “pain in the diaphragm” that was also recorded on the preoperative questionnaire.

The risk for dysphagia was a major focus for the investigators. When the prosthesis is placed at the hiatus, it can induce inflammation and scarring leading to fibrosis, stenosis and eventually dysphagia. In this series, six patients (9%) had worsened dysphagia after surgery. Of these, two patients said the dysphagia was severe. Follow-up studies performed elsewhere revealed that one of these patients had a “tight wrap” but without stricture or erosion, and dilation did not improve the patient’s symptoms. “It is possible that mesh could be a contributing factor,” the authors said.

Overall, the rate of dysphagia in the study was 2%. This rate compared favorably to other studies of patients who underwent Nissen fundoplication without the use of mesh.

The study provides some reassurance about the safety of biologic meshes but concerns remain, said Emanuele Lo Menzo, MD, PhD, associate professor of surgery, University of Maryland Medical Center, in Baltimore. “This study has long-term follow-up, which gives us a little bit of breathing room to say that biologic meshes seem to be safe. Certainly, at the University of Washington, it seems to be.”

He added, however, that there are flaws in the study. More than one-third

of patients treated could not be contacted and among those who were contacted, no patients underwent firsthand endoscopic or radiologic evaluation at their treating institution. Furthermore, the institution has very experienced surgeons; thus, the results are likely to be difficult to reproduce.

Dr. Wassenaar said the surgical team uses three key strategies that may reduce the risk for complications. They advocate the use of a U-shaped, rather than a keyhole configuration, which leaves an open area in the anterior aspect of the esophagus, and recommend covering the hiatus posterior to the esophagus, taking care to avoid pulling the mesh anteriorly and lifting the esophagus posteriorly to avoid narrowing the esophagus. They also suggest leaving a small space between the edge of the mesh and the esophageal wall to avoid excessive contact of the mesh with the esophagus. The team developed this technique after studies conducted in dogs revealed some fibrosis and scarring, leading to an esophageal stricture.

Despite the study’s findings, uncertainty remains about the long- and shortterm success of biologic mesh repair in large hernias, other surgeons noted.

“It’s very confusing [because of ] mixed results from the studies. We still don’t know how biologic meshes are going to hold up long-term for large hiatal hernia repairs,” said Constantine T. Frantzides, MD, PhD, director of the advanced laparoscopic and bariatric fellowship program, Saint Francis Hospital, and director of the Chicago Institute of Minimally Invasive Surgery, in Skokie, Ill. In 2011, surgeons reported results from a multicenter randomized trial of laparoscopic paraesophageal hernia repair that compared primary diaphragm repair with primary repair buttressed with a biologic prosthesis (JACS ( 2011;213:461-468).

The study showed that repair using biologic mesh was not associated with higher rates of complications or side effects but that there was no benefit in reducing hiatal hernia recurrence with follow-up of more than five years.

Dr. Frantzides said more time and more studies are needed to settle the issue of synthetic versus biologic mesh repair. A randomized controlled study, led by Dr. Frantzides, confirmed the benefit of mesh in large hiatal hernia repair (Arch ( Surgg 2002;137:649-652); however, there is little agreement about the ideal material of the mesh in these repairs, he said.

“Personally, with large defects, I don’t think the biologic mesh will hold. But this is something that we cannot settle without having time to follow these patients long-term,” he said.

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GERD AND HERNIA jContinued from page 1

surgery, and he sees many patients with severe GERD, an increasing number of whom are obese.

Although procedures specifically for the treatment of GERD and/or hiatal hernia may address those problems, they do nothing to address the underlying obesity that contributes to or exacerbates those problems and may increase risk for recurrence. The patient with a body mass index (BMI) of 40 kg/m2 who receives a fundoplication at age 35 is likely to be

just as heavy if not heavier 10 years later, and to accumulate the comorbidities associated with obesity. “If they are interested then in pursuing bariatric surgery, it’s going to be much more difficult,” Dr. Gould said. “You’ve burned a few bridges by that point.”

Dr. Gould frames the context of bariatric surgery for these patients in three different scenarios. First is the obese patient with GERD who wants help for reflux.

“They have been sent to you to talk about fundoplication, but you need to bring up the fact that bariatric surgery is probably the better choice once they get into that

‘I’ve done gastric bypasses on people with GERD and they are better immediately.

Also, as they lose weight, the elevated intra-abdominal pressure associated with obesity starts to decrease.’

—Jon C. Gould, MD BMI category,” Dr. Gould said. “Fundoplication has a higher failure rate [in

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obese patients], and in my experience, it’s much more difficult to do a Nissen than a gastric bypass on patients with a BMI in the 40s and 50s.”

As a surgeon who does a lot of reoperative anti-reflux surgery, Dr. Gould gets a bit frustrated when he sees obese patients with failed fundoplications who were not informed about the option of bariatric surgery. “Even more frustrating is the patient who has a Nissen for GERD and later enrolls in a bariatric program and wants surgery,” he said. “They could have had one operation up front. Now it’s a risky procedure because you have to take down the Nissen before doing a gastric bypass.”

The second scenario Dr. Gould sees is the patient interested in and indicated for bariatric surgery who turns rns ou out to have

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GERD with or without a hiatal hernia.

In this case, the question is whether the choice of bariatric surgery should be guided by the presence of the hernia or the diagnosis of GERD. The third scenario is an obese patient with a large, symptomatic paraesophageal hernia who may or may not have GERD but is experiencing symptoms related to the hernia such as chest pains or dysphagia. “Should you do a traditional laparoscopoic paraesophageal hernia repair, or manage that hernia with a gastric bypass or sleeve gastrectomy?”

For patients from the first scenario, Dr. Gould suggests gastric bypass as an ideal procedure for a variety of reasons ((Ann Surg 2010;251:244). After the gastric pouch is created and the stomach is divided, most of the parietal cells remain in the bypassed stomach, so the acid, as well as pepsin and bile, are for the most part mechanically diverted away from the esophagus.

“I’ve done gastric bypasses on people with GERD and they are better immediately. Also, as they lose weight, the elevated intra-abdominal pressure associated with obesity starts to decrease,” lowering one of the risk factors for GERD, Dr. Gould said.

The evidence is less clear for gastric banding and GERD. In a review of 20 studies of 3,200 patients, “resolution versus improvement, versus worsening of GERD symptoms, versus newly developed GERD symptoms after band

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS INTERNATIONAL EDITION 2012

placement, it’s all over the map,” Dr. Gould said ((Aliment Pharmacol Therr 2009;30:1112). “Data suggests short-term resolution or improvement of symptoms, but in the long term, there are concerns about worsening or newly developing symptoms with the band.”

Sleeve gastrectomy is probably not the best option. “There’s data out there suggesting that patients who have GERD at the time of sleeve gastrectomy are very likely to continue to have GERD, and there is a fair number of people who do not have symptoms prior to sleeve who develop those symptoms later,” Dr. Gould said.

In the obese patient with a hiatal hernia, gastric banding could be feasible.

“Hiatal Hiatal hernia has been considered a con con-

traindication for a band, but that’s less nowadays,” Dr. Gould said. In past studies examining the repair of small hiatal hernias (1-2 cm), at the time of band placement, the incidence of band slippage is low.

Sleeve gastrectomy may be a good option for the patient with a large, symptomatic paraesophageal hernia and associated short esophagus in whom it is difficult to mobilize the gastroesophageal junction below the diaphragm during surgery.

“A sleeve gastrectomy is like a really long neo-esophagus, a tube that goes all the way down to the pre-pyloric area of the stomach,” Dr. Gould said. “It’s a pretty radical esophageal-lengthening procedure, and it minimizes the opportunity for the stomach to herniate back through the diaphragm into the chest for a recurrent paraesophageal hernia.”

Although there are no long-term data to support sleeve gastrectomy in patients with paraesophageal hernias, Dr. Gould thinks it makes sense. “It’s analogous to the lengthening procedure we would do.”

The flip side of success in treating these three patient scenarios with bariatric surgery is the agony of getting insurance to pay for it.

“That’s the difficult part,” Dr. Gould said. “You and the patient decide bariatric surgery is the right thing to do, but the insurance company says no and the only thing they’ll pay for is the fundoplication.

That’s not an uncommon scenario in my

request to perform a gastric diversion, which is much like a gastric bypass.

“When I think a patient needs to have a gastric —Dimitrios Stefanidis, MD, PhD diversion done, I submit to insurance and typically they practice and it’s really frustrating.” reject it,” said Dr. Stefanidis, who is medical director, Carolinas Simulation CenFailed Fundoplication ter, Carolinas Medical Center, Charlotte, Dimitrios Stefanidis, MD, PhD, who N.C. has been using bariatric surgery to treat “Then I have to talk to one of the medpatients after prior failed fundoplica- ical directors, and most of the time they tions, also usually gets stonewalled at first approve it. They understand the rationale by insurance companies that reject his of why it’s important,” said Dr. Stefanidis,

‘When I think a patient needs to have a gastric diversion done, I submit to insurance and typically they reject it.’

In the News noting that this approach does not always work with Medicare, which does not follow a precertification process.

Dr. Stefanidis started performing gastric diversions instead of redo fundoplications after noting the high rate of fundoplication failure in obese patients and high recurrence rates of reflux after redo fundoplications.

In research presented at the 2012 SAGES meeting, Dr. Stefanidis and colleagues assessed outcomes and quality of life in 25 patients who underwent gastric diversions, which is like a gastric bypass see GERD AND HERNIA PAGE 14

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In the News

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Patients Prefer Colonoscopy to CT Colonography, Study Shows B Y D AVID W ILD

screening schedule, said lead investigator Greg Rosenfeld, MD, clinical assistan nt professor in the Department of Family Practice and a gastroenterology fellow at the University off British Columbia’s Department of Medicine in Vancouver. To better understand the question, Dr. Rosenfeld and d his colleagues enrolleed 90 patients (mean age, 55 years) to undergo CTC and

SAN DIEGO—Patients undergoing screening for colorectal cancer (CRC) experience less pain and have less anxiety with colonoscopy than patients undergoing computed tomographic colonography (CTC) screening, according to findings from a prospective questionnaire-based study presented at the 2012 Digestive Disease Week meeting (abstract 445).

Researchers asked 90 patients being screened for CRC to undergo both CTC and colonoscopy on the same day and found that 77% said they would prefer colonoscopy for repeat ‘I think that, overall, screening. colonoscopy is a better test The findings are important “in that they allow me say with confidence that than CTC for screening and CTC colonoscopy is not less comfortable than should be reserved for cases CTC, but that most patients would find it more comfortable,” said Douglas Fai- where patients are unwilling gel, MD, professor of medicine at Mayo to undergo colonoscopy or it cannot be safely Clinic in Scottsdale, Ariz., who was not completed.’ —Greg Rosenfeld, MD involved in the study.

“Along with these findings, and given that colonoscopy has been shown to prevent CRC inci- subsequent colonoscopy on the same day. Participants dence and mortality while similar data are lacking on received midazolam and fentanyl or meperidine during CTC, I would recommend colonoscopy as the best test colonoscopy, but no sedation or analgesia during CTC. for detecting and preventing CRC,” Dr. Faigel added. The subjects completed a 13-item patient satisfaction “I would reserve CTC for the subset of patients who questionnaire following each procedure. are truly unwilling to undergo colonoscopy but [are] The findings showed that 36% of patients felt less willing to have a CTC.” anxious during colonoscopy, whereas 14% reportPatient preference may affect adherence to a CRC ed experiencing less anxiety with CTC (P<0.0001).

GERD AND HERNIA jContinued from page 13

but includes removal of the gastric fundus, after one or more failed fundoplications (S051).

The mean BMI was 34.4 kg/m2 (2250 kg/m2). The patients had undergone a total of 40 prior anti-reflux operations, and 23 had associated hiatal hernias.

There were no deaths, but 11 patients had complications, and five required reoperation.

At 14 months, mean excess weight loss was 60%, and 96% of patients reported being free of reflux and feeling better about their appearance. Many felt the operation had improved their social and sexual lives, and 96% indicated they would do it again. There was no difference in quality of life between the obese and nonobese patients.

The researchers concluded that gastric diversion results in excellent control of reflux and improved quality of life, but noted that the procedure can be quite challenging, especially in patients whose anatomy has been severely compromised by scarring from past operations.

“We did the vast majority of these cases laparoscopically; many of those

patients had two or three prior surgeries, and about 50% had had open surgeries,” Dr. Stefanidis said. “It can take five to seven hours to do these procedures laparoscopically.”

A frequent challenge he has faced has had more to do with bowel obstructions due to previous scar tissue and less to do with taking down the Nissen. “Especially after prior open surgeries, a lot of these patients have incisional hernias in the abdominal wall,” Dr. Stefanidis said.

In addition to the technical challenges is the difficulty in working with patients who may have trouble adjusting to the impositions of bariatric surgery.

“When we do a gastric bypass on obese patients, they know what they’re having and why,” he said. “But the bypass requires a big adjustment phase. You can only eat about one ounce after the surgery, and some of the patients who have the procedure for reflux have difficulty adjusting initially despite the counseling we have given them beforehand.”

He often will place a feeding tube in the gastric remnant of normal-weight and/or more complicated patients to help them stay hydrated and avoid hospitalization. Incidentally, although the normal-weight patients also lose some weight early on, they tend to gain most

Additionallly, 69% of patients said they ffelt less pain or discomfort during d colonoscopy, whereas only 4% said they felt morre comfortable during CT TC (P P<0.0001). In terms of overall satisfaction, 330% of participants prefeerred colonoscopy ratheer than CTC in contrast to 4% who were moore satisfied with CT TC (P<0.0001).

P The remainder of T rrespondents to the th hree questions did not demonsttrate a strong preference either way.

Notably, 77% of patients said they t would rather undergo colonoscopy for repeat scre screening.

Although the palatability of CTC may be improved if patients were to receive sedation and analgesia, Dr. Rosenfeld insisted the conclusions point to the continued place of colonoscopy as the gold standard in screening for CRC. “I think that, overall, colonoscopy is a better test than CTC for screening, and CTC should be reserved for cases where patients are unwilling to undergo colonoscopy or it cannot be safely completed,” Dr. Rosenfeld concluded.

Drs. Faigel and Rosenfeld have no conflicts of interest.

of it back and stabilize at normal.

Bipan Chan, MD, of the Cleveland Clinic in Ohio, and colleagues considered an entirely different population in their research on longitudinal gastrectomy—following the principles of a Collis procedure with some elements of sleeve gastrectomy—in obese patients with GERD and/or hiatal hernia.

“Most people would agree that the best operation for these patients is a gastric bypass, but there is a patient population that either doesn’t like the idea of gastric bypass or who don’t qualify based on their insurance,” said John H. Rodriguez, MD, a postgraduate year 4 resident with Dr. Chang’s group who presented the research at SAGES (S106). “That leaves these patients untreated because we don’t want to do an anti-reflux procedure that is likely to fail, and we can’t do a gastric bypass.”

Under institutional review board protocol, the researchers performed longitudinal gastrectomy in 19 patients with a mean BMI of 37.8 kg/m2 and type III or IV paraesophageal hernias. Of the 17 who completed follow-up questionnaires on weight loss, patient satisfaction, use of proton pump inhibitors and/ or H2 blockers at a 13-month followup, there was a significant decrease in

symptoms and use of medication. Mean excess weight loss was 29%, with three patients losing no weight, and some losing quite a bit.

In the question-and-answer session following Dr. Rodriguez’s presentation, the procedure was criticized for both destroying the hiatus and for resulting in little weight loss.

“Anytime you try something new, you get a lot of criticism,” Dr. Rodriguez said. “Our operation tries to reproduce the anatomic and physiologic components that prevent reflux. It also adds the benefits of weight loss, which reduces the risk for a symptomatic recurrence.”

Dr. Rodriguez explained that they reconstruct the hiatus as they would with any other patient, doing a primary closure and reinforcing with mesh depending on how the defect looks. As for the sleeve portion, which is less restrictive than a traditional sleeve gastrectomy and doesn’t reach as far, the creation of a tubular stomach eliminates the risk for a volvulus in the event of a recurrence.

“I don’t think we’re combining the worst of both worlds—I think we’re doing the exact opposite, combining the best of both worlds,” Dr. Rodriguez said.

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Experts Discuss Endoscopic Repair of Colonic Perforations How far could we push ourselves in terms of the size of the polyp perforation we could close, and how does it compare with surgery?” Dr. Raju said.

NEW YORK K—The time may have arrived when endoscoDr. Raju and his team found that indeed they could pists can, and should, treat perforations in some patients apply a leakproof seal on perforations, and that these who would have been referred to surgery, according to repairs, along with sidestepping all the risks associated G.S. Raju, MD, professor in the Department of Gastro- with major surgery, also resulted in fewer adhesions than enterology, Hepatology and Nutrition at the University surgery. of Texas MD Anderson Cancer Center, Houston, who “We know now how to close a perforation that is linspoke at the annual course of the New York Society for ear and a perforation that is horizontal,” he said.

Gastrointestinal Endoscopy, held in December.

Of course, prevention is the most important factor in “You could actually managing perforations. Preventative measures manage these patients by include ensuring thorough bowel preparation, ‘In the heat of battle, maintaining endoscopy,” Dr. Raju told a dry field and proper colonoscope meeting attendees, sumtechnique. Examination of any resection site is it can sometimes be marizing his review of the to identify any perforation that might difficult to make some essential topic that was published have occurred and to gauge the next step. in the December issue of of those decisions ... We “One-third of perforations can be diagnosed at Gastrointestinal Endoscopy the time of the procedure, and this gives us an must remember to first, opportunity to close a perforation,” Dr. Raju said.

(2011;74:1380-1388).

“Over the past couple of It is also important to identify those patients do no harm.’ decades, we have learned who will develop post-polypectomy syndrome or —George Chang, MD to control bleeding, and it a perforation after the procedure, and to recogis now extremely rare for a nize which patients will benefit from prophylacpatient to go to surgery to control that complication,” Dr. tic closure of a defect. Delayed perforations usually occur Raju said. “But we have not done the same thing for per- within the first day or two, and up to two weeks after the forations. So in this past decade, we are making progress procedure. After two weeks, the patient is in the clear. to treat that complication.”

“If we want to catch all the perforations that happen in Colonoscopy-related perforations generally result endoscopy, we should set up a system whereby you confrom mechanical or thermal injury during polypectomy. tact the patients within 14 days after the procedure,” Dr. They are relatively rare—depending on the type of resec- Raju said. tion used to remove polyps, the risk for perforation can vary from 0.1% to 5%, with endoscopic mucosal resection A Surgeon’s Perspective (EMR) and endoscopic submucosal dissection (ESD) George Chang, MD, MS, associate professor of surcarrying the highest risk. When perforations do occur, gical oncology and associate medical director of the they result in an air leak within seconds. If the leak is not Colorectal Center at MD Anderson Cancer Center, recognized and repaired quickly, the injury can result in commended Dr. Raju and his colleagues for their work tension pneumoperitoneum. After time, fluid will leak in the endoscopic management of perforations. and lead to peritonitis and sepsis.

“We’ve long identified that patients with small perTraditionally, upon recognizing that a perforation has forations who are clinically asymptomatic and identified occurred, an endoscopist would refer the patient to a sur- with minimal pneumoperitoneum or pneumatosis after geon, who would likely take the patient to the operat- endoscopic procedures often can be managed without ing room. The patient would undergo general anesthesia, an operation. Obviously, the goal of treating patients is a laparotomy or thoracotomy, and dissection to identify to treat them in as minimally invasive a way as possible, the perforation, followed by repair of the perforation and but without compromising safety, and that’s the key,” said a fairly extensive recovery.

Dr. Chang, who is director of clinical operations in the “This approach has a significant morbidity and mor- Minimally Invasive and New Technologies in Oncologic tality, which could be avoided if we take a different route of endoscopy closure,” Dr. Raju explained. “That perforation is going to be small, and we can close it with clips so that the patient doesn’t need surgery. That’s a paradigm shift from surgical to nonsurgical management.”

B Y M ONICA J. S MITH

Moving Toward Nonsurgical Management Only a decade ago, surgery was the only option for patients who suffered perforation—the tools and techniques had not yet been developed to allow endoscopists to manage perforations on the spot.

“We started [laboratory animal research] to answer the questions: Could perforations be closed? If so, could we create a leakproof sealing?

Surgery Program, at MD Anderson.

“I would recommend engaging surgical consultation earlier rather than later,” he noted. “Patients will need to be very closely monitored to ensure that a more significant complication has not occurred.”

Close monitoring is also important in the event that the endoscopic repair fails, despite initially appearing to have worked.

“The closure may be attempted and may appear to be technically successful, but the patient could have a clinical deterioration,” Dr. Chang explained. “You cannot do this [repair] and then forget about the patient.”

Another point Dr. Chang stressed is that an endoscopist faced with a complex polyp should take careful stock of his or her own skills in EMR or ESD before attempting to remove the lesion.

“In the heat of the battle, it can sometimes be difficult to make some of those decisions. This is clearly an advanced technique that only appropriately trained endoscopists should attempt. We must remember to first, do no harm.”

Dr. Chang added that the endoscopic management of perforations is not for everyone: “not for every patient, not for every polyp and not for every endoscopist.”

Training Opportunities Considering the rarity of colonoscopy-related perforations and the challenges of endoscopic management, some may wonder what would motivate an endoscopist to learn these techniques.

“I think, like anything else, this takes time for people to get used to,” Dr. Raju said. “You don’t lose anything if you try to close it; if you can’t, the patient needs to go to surgery. It’s not much different from using a biopsy forceps—it’s a bit of a technical detail. The way I look at this is that you need to learn the technique of clip closure so that you can push yourself to do additional things you would not have otherwise undertaken.”

In other words, endoscopists who learn to close perforations may be able to apply that knowledge to other challenges in endoscopy.

“Learning the techniques to close a perforation will equip you to do a little more, to take the extra steps to remove the large, flat lesions that would traditionally have been sent to surgery,” he said, noting that he and his colleagues found this to be true for themselves as they gained confidence in managing perforations endoscopically.

As with learning any new skill or technique, it does take time and practice to manage perforations with throughthe-scope or, less commonly, over-the-scope clips. Furthermore, gaining experience may be difficult considering the relative rarity of perforations. Dr. Raju suggests starting small, such as managing routine defects after polyp removal, to gain skill and confidence with using endoscopic clips.

“When we remove polyps, we often create defects, which are not through and through. You can try to close those defects [with a clip] and gain experience that way,” he suggested. “If you have a deep defect, you could reinforce the wall and prevent a delayed perforation. This is something you can work on in your practice.”

Drs. Chang and Raju reported no relevant conflicts of interest.

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16

Opinion

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An Evolution in the Management of Colonoscopic Perforations One Surgeon’s Experience B Y G ARY H. H OFFMAN , MD

E

ndoscopic management using through-the-scope clips is a proven tool for both preventing a perforation after polypectomy and for treating a recognized perforation (see “Endoscopic Management of Colonic Perforation,” page 11). However, a more common clinical situation is the presentation and recognition of the perforation in the recovery room or after the patient has been discharged. At this point, the patient is in severe pain. The abdominal exam, a mainstay of physical diagnosis, is of no value as the abdomen is distended and tense, rendering the exam useless in following the patient’s clinical course.

Operative intervention is commonly the next step.

I would suggest an additional approach in the management of many of these patients with an endoscopic perforation: immediate, ultrasound-guided abdominal paracentesis, followed by vigilant, nonoperative observation. The patient will be relatively pain-free after the paracentesis, allowing the surgeon to better use the abdominal exam as a guide to continuing close observation or proceeding to the operating room. To follow this course, the surgeon must possess surgical fortitude, vigilance and the flexibility to change course should the clinical findings warrant a change.

Painful Experiences In my experience with more than 13,000 colonoscopies performed over 28 years, four of my patients have experienced perforations, a rate of 0.03%.

National rates for colonoscopic perforations range from 0.1% to 0.3%. All four perforations occurred in patients who had undergone a complete colon preparation prior to the colonoscopy. All perforations were recognized in the recovery room. All of the procedures had been performed without difficulty and without a concomitant polypectomy. None of these patients had a large, gaping, scopeinduced colotomy.

The first patient underwent an immediate laparotomy. Upon opening the abdomen, there was a rush of free air, but a site of perforation or other abnormality was not found. No other intervention was undertaken and the patient did well.

I began to re-evaluate the treatment approach to an endoscopic perforation. I wondered if the cause of the patient’s abdominal pain was secondary to the abdominal free air with peritoneal

distention, or due to either a leak of colonic contents or the actual colotomy itself. Was an immediate laparotomy really necessary?

An endoscopic perforation might be analogous to a self-sealing, diverticular perforation. In many pain-free patients with a diverticular perforation and an unprepared or “dirty” bowel, treatment is often expectant and nonoperative. I came to believe that it might be possible to avoid operative intervention in patients with post-colonoscopy perforations. I postulated that the intense postperforation abdominal pain was a result of abdominal distention and peritoneal membrane distention from the intraabdominal free air and not from the perforation itself or from the leak of any colonic contents.

What if I could monitor a pain-free patient with an iatrogenic perforation?

Would I better be able to follow the patient’s clinical course without being adversely influenced by a tense, painful abdomen?

The Nonoperative Approach Begins The next two patients whose perforations were diagnosed in the recovery room had extensive diverticulosis with thin, fragile diverticular walls. I suspected that the insufflation of air, or the movement of the scope through the colon had caused the perforation. I immediately hospitalized these two patients, ordered nothing by mouth and prescribed antibiotics and liberal amounts of pain medication. I opted then for close observation without immediate surgical intervention. I watched these two patients closely, knowing that I could handle the problem if there was a turn for the worse. Initially, I evaluated them three times each day in the hospital and awaited signs of normal flatus production, signaling the return of bowel function. I was fully prepared to operate with even the smallest worrisome physical finding or with worsening laboratory data. Both patients did well, with resolution of abdominal pain in four to six days. The abdominal bloating lasted longer but eventually resolved. I took heart that I had been correct in my treatment logic and in my patient care.

The Nonoperative Approach Evolves The decision to operate often is driven by the sight of a patient who is in

intense abdominal pain. Urgent operative intervention for a perforated viscus is the most common method of treatment. This is one of the first lessons learned during residency. However, most surgeons do not perform a high volume of colonoscopies and therefore do not have a wide breadth of experience in this specific area. When you are a hammer, everything looks like a nail.

Surgeons are often hammers. However, not all patients are nails and not all postcolonoscopy perforations require surgical intervention.

What if I could monitor a pain-free patient with an iatrogenic perforation?

Would I better be able to follow the patient’s clinical course without being adversely influenced by a tense, painful abdomen? This situation would be similar to that of observing a patient who has a perforated, self-sealing colonic diverticulum and minimal abdominal pain. Perhaps not all nails would require immediate hammering.

Ultrasound, Paracentesis and Close Observation When I encountered my fourth patient with a post-colonoscopy perforation, I asked the radiologist to remove all of the intra-abdominal free air using ultrasound guidance. With this accomplished, my patient simply sat in the hospital, pain-free and bored. After the return of bowel function, the patient was started on a clear liquid diet, which was accompanied by mild cramping that quickly resolved. The patient was discharged home four days later on a progressive diet.

Rather than using the distended and tender abdomen as reason to operate, I had been able to monitor a pain-free patient and use any new onset of pain as a marker for a worsening situation, possibly requiring surgical intervention.

This did not happen and no other intervention was necessary.

A Question for You To Ponder Although I have a new perspective on the evaluation and treatment of postcolonoscopy perforations, I hope never to need to use this knowledge or experience. A nonoperative treatment protocol requires extreme vigilance and diligence with frequent examinations of the patient, the vital signs and labs as well as in-depth training in the care of abdominal emergencies. I knew that I could successfully handle the problem no matter the clinical course, and I could always turn quickly to the scalpel if anything were to change. I was willing to shoulder the load of watchful waiting,

I asked the radiologist to remove all of the intra-abdominal free air using ultrasound guidance.

With this accomplished, my patient simply sat in the hospital pain-free and bored. while gaining some new gray hairs in the process.

A surgeon is often the final treating physician or consultant responsible for a decision to operate or not. In the end, the surgeon must decide if he or she has the experience, the skills and the surgical fortitude to follow a patient who traditionally, and most commonly, is taken to the operating room immediately. The surgeon will experience considerable anxiety while pursuing this nonoperative path. Obviously, the anxiety will lessen with an improving clinical course, but the wait can be trying for the surgeon. A comfortable, pain-freee patient will allow the surgeon some increased measure of objectivity, so that the patient can be followed, and the symptom of pain can be used more objectively as a signpost, rather than an indication for immediate operative intervention.

Finally, a fifth patient underwent a rather large cecal polypectomy, at which time I placed three prophylactic through-the-scope clips for added protection against a perforation. The patient called the day after the procedure, complaining of right lower quadrant pain. A computed tomography scan showed two small extraluminal air bubbles. The pain resolved almost immediately with hospitalization, bed rest, intravenous fluids and antibiotics. The patient was discharged home.

Through-the-scope clips have become a major adjunct in our armamentarium and the authors are to be commended for their analysis of the endoscopic management of colonic perforations. But, as always and in any situation, experience, planning and preparedness are our best tools.

Dr. Hoffman is an attending surgeon, in the Divisions of Colorectal Surgery and General Surgery, and an instructor in the Colon and Rectal Surgical Fellowship at Cedars-Sinai Medical Center, Los Angeles.

He is a senior member of Los Angeles Colon and Rectal Surgical Associates (www.lacolon.com).

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International Fellowship Programs Open a World of Opportunity B Y C HRISTINA F RANGOU

I

n summer 1997, young German surgeon Hermann Kessler, MD, PhD, arrived in Cleveland, Ohio, to begin a fellowship in laparoscopic colorectal surgery.

Over the next 24 months, Dr. Kessler enhanced his laparoscopic skills, studying computer programming and database management on the weekends. He improved his English so much that the Cleveland Clinic eventually asked him, with his slight British inflections, to do voice-overs for their medical videos.

Fifteen years later, Dr. Kessler said that international fellowship set the trajectory for the course of his career.

“Those two years of fellowship gave me a platform to learn, and the opportunity to build up a network all the way around the world.”

Dr. Kessler returned home to the University of Erlangen in northern Bavaria and set up a laparoscopic colorectal program and a database for tracking outcomes. “As soon as I got home, the chairman asked me to do a laparoscopic sigmoid on one of his private patients. They watched me very carefully to make sure that I hadn’t been partying the two years I’d been away.

It was a very big event in the department. Even the chair of orthopedic surgery came in to watch,” said Dr. Kessler, now a professor of surgery at the University of Erlangen.

Since then, Dr. Kessler has completed more than 800 laparoscopic colorectal cases, and has presented all over the world, including Japan and Australia. He recommends that all surgeons try to get international experience. “It can only be an advantage.”

‘Being abroad enhances the fellow’s ability to keep an open mind.’

—Mark Carlson, MD

offers some insight into the benefit of an international fellowship (JACS ( 2010;211:279-284). Participants in the program may be North Americans who travel abroad, or surgeons who come to the United States Evolving International Fellowships or Canada to train. Many scholars said that the proSurgeons have been going outside of their home gram had a positive influence on their careers: 38% felt countries for centuries to observe other surgical practic- it provided opportunities not otherwise possible, 47% es. Even in the 19th century, surgeons from the United felt it was extremely helpful and 12% believed it was States would travel to Europe for training. According somewhat helpful. Respondents said their trips directto a 2010 report in the Journal of the American College of ly affected their clinical care. Scholars said they learned Surgeons, about 15,000 American physicians traveled to new techniques, which they now practice in their home Europe to train between 1870 and 1914 (211:279-284). departments, and their contact with leading surgeons Over the past decade, the number of available inter- led to improvements in their work and practice. national fellowships has grown and is continuing to do Fellowships bring hardships, too. Trainees are away so. Although no one tracks all available surgical fel- from family and friends; they often work in a second lowships internationally, there is no question that more language; the financing can be difficult; and, for some, professional societies and institutions now fund inter- they worry about putting themselves out of the job marnational fellowships than ever ket in their home country.

‘The relationships that I built during Sonal Nagra, MD, is curbefore.

Today, many types of interrently spending one year my fellowship continue to help me, away national fellowships exist. They from his home in Fiji can be clinical or research- and gave me the opportunity to build while he finishes a surgical based, or both, as short as one fellowship in Dunedin, New up a network all the way month or as long as several Zealand. He left to gain years. Surgeons can travel to experience in laparoscopic around the world.’ all seven continents (in Anttechniques that are not rou—Hermann Kessler, MD, PhD arctica, contract positions are tinely available in Fiji but it available as medical and surgiwas a tough decision to leave cal officers, but no fellowships per se). Fellowships exist even for a year. His wife left her job as a general pracfor surgeons just starting out in their career, and those in titioner at Fiji’s largest hospital to join him. The climid or even late careers. Most are designed to enhance mate took some getting used to as well. As warm as a surgeon’s skills and allow them to gain new cultural New Zealand can be, it doesn’t compare with Fiji. And experience. Others, like the Paul Farmer Global Sur- he had to work to reestablish the confidence of peers, gery Fellowship, are designed to address surgical care in supervisors and staff. resource-poor settings throughout the world.

Overall, however, fellows said their internationA 2010 survey of former recipients of the Ameri- al experience helped their careers by enhancing clinical can College of Surgeons’ international scholars program skills and knowledge and developing relationships with

surgeons around the globe.

Dr. Nagra said he will return to Fiji better able to deal with the unique challenges of practicing “Pacific Medicine.” “Being able to gain more experience and bring this back to the Pacific in any form possible would be an asset to the health system locally.”

Dr. Kessler noted, “The relationships that I built during my fellowship continue to help me, and gave me the opportunity to build up a network all the way around the world.”

Even in the era of Internet, Skype and online educational opportunities, there is tremendous value in training abroad. “There’s a famous quote that sums it up quite nicely: ‘Whenever you can take a walk in someone else’s shoes, the world becomes a better place,’” said Mark Carlson, MD, professor of surgery, University of Nebraska Medical Center, Omaha.

In 2007, Dr. Carlson studied in Germany for four weeks as an American College of Surgeons Traveling Fellow. He toured different hospitals and met with surgeon-researchers, several of whom he continues to work with today.

A traveling fellow can see how other surgeons approach similar problems. They see that there often is more than one way to treat a disease and get still decent outcomes, said Dr. Carlson. “[This experience] can enhance the fellow’s understanding or tolerance for doing things differently. Sometimes, because of our training, we fall into a mindset and if anything falls out of that mindset, it might be looked on with disapproval. Being abroad enhances the fellow’s ability to keep an open mind.”

The American College of Surgeons, the Australasian College of Surgeons and the Royal College of Surgeons, as well as individual institutions, offer multiple international fellowships. Application information is available on the Colleges’ Web sites.

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In the News

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New App Predicts Chronic Pain After Inguinal Hernia Surgery B Y C HRISTINA F RANGOU NEW YORK K—Surgeons and patients considering hernia surgery can now use a free app that predicts a person’s chance of experiencing chronic pain after inguinal hernia repair, based on the outcomes of nearly 1,700 patients treated over the last five years. The app, the Carolinas Equation of Quality of Life (CeQOL), was officially launched at the 5th International Hernia Congress and can be

downloaded for free on smartphones and computers.

The app will help educate patients about the risks for chronic pain, an issue sometimes glossed over in preoperative discussions between physicians and patients, said B. Todd Heniford, MD, senior researcher of the team that designed the app and chair of gastrointestinal and minimally invasive surgery at Carolinas Medical Center, Charlotte, N.C. “This app opens up the discussion about the chance

of chronic discomfort following inguinal hernia surgery and gives patients a very specific idea of risk,” said Dr. Heniford.

“It sets the stage for what we should strive for with every operation: an objective plan to obtain personal quality-of-life [QOL] outcomes for post-operation and therapy.”

Between 8% and 40% of patients who undergo inguinal hernia repair have chronic pain after surgery, according to previous studies. That pain often triggers legal action against physicians and

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hospital systems. In the United Kingdom, chronic pain following hernia repair is the No. 1 cause of malpractice suits.

In the United States, 35% of all malpractice case law that relates to hernia repair is related to chronic pain or discomfort.

Bruce Ramshaw, MD, a hernia surgeon and chief medical officer for the Transformative Care Institute, in Daytona Beach, Fla., who won the World Hernia Congress Resident/Fellow Research Award for 2012 for this project, said the app marks a change in the way outcomes after medical and surgical care are measured.

“This app is great because it’s focused on patient QOL and outcomes from the patient perspective. That’s the direction we are going as a hernia society.”

The app is based on an algorithm developed by Igor Belyansky, a fellow in laparoscopic surgery at Carolinas Medical Center. Dr. Belyansky and colleagues studied data collected between September 2007 and September 2011 by the International Hernia Mesh Registry, a prospectively collected multicenter database that includes data on patients from 30 sites in Canada, the United States, Europe and Australia. Patients submit data to the registry, by mail or email, and answer questions regarding QOL, Carolinas Comfort Scale scores and postoperative complications. Researchers studied 2,146 inguinal hernia patients, after excluding cases where more than 10 tacks were used in the repair. [An earlier study, from the same group, showed that the use of more than 10 tacks increases long-term pain ((Ann Surgg 2011;254:709-714).]

The average age of the patients was 56.4±14.6 years; 94% were male and 38% underwent laparoscopic repair. Overall, 20% of patients had bilateral repair and 12% were treated for a recurrent hernia.

Almost 58% of patients reported preoperative pain. Patients were queried at regular intervals for a year after their hernia repair (77.7% follow-up rate). One month after surgery, just over one-fourth of patients (26.1%) reported postoperative pain, which dropped by more than half over the next year, with 12.5% reporting postoperative pain one year after surgery.

The investigators found that younger age, female gender, bilateral repair, recurrent inguinal hernia repair, preoperative pain, postoperative hematoma, postoperative recurrence and postoperative urinary tract problems all were predictive of chronic pain. Based on these results, the researchers developed an algorithm to predict chronic pain. They used a random sample of 80% of patients in the

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and assistant professor of surgery at the University of Southern California.

The new app keeps the focus on patients, she said. “What this app helps quantify in very real terms, and for the first time ever, is how much chronic pain a typical patient may suffer based on simple preoperative symptoms,” said Dr. Towfigh. “Surgeons can help use this app to educate their patients about the risks and benefits of hernia repair.”

Dr. Heniford, who is the outgoing president of the American Hernia Society, encouraged surgeons and their patients to use the app. Currently, the app

applies only to men, because of a shortage of outcomes data following hernia repair in women. He said CeQOL represents a paradigm shift in which the success of a procedure is judged not only by recurrence rates, which are quite low, but also by patients’ QOL. “The team should be congratulated for pioneering an app that bridges evolving technology and patient care outcomes. As CeQol gets used by multiple surgeons and patients, its validity and usefulness will be tested,” said Brian Jacob, MD, attending surgeon at Mount Sinai Medical Center, in New York City. “Pain complaints after

21

hernia surgery, in general, are very subjective, and often factor in many variables that are dependent on any given surgeon's technique, patient population and followup regimen,” he said. “Such variables make it tough for an app to reliably account for things like the type of hernia repair being performed, the surgeon's experience with the technique and the location or type of pain complaint being reported. Therefore, the risks that CeQol produces might have a chance to overestimate or generalize.”

Dr. Jacob said he plans to use the app in his own practice and see “how reliable it is with my patients.”

‘It’s a tool that sets the stage for what we should strive for with every operation: an objective plan to obtain personal quality-of-life outcomes for post-operation and therapy.’

—B. Todd Heniford, MD database to develop the algorithm and confirmed the results in the remaining 20% of patients. A Harvard statistician independently tested the equation, and confirmed its sensitivity and specificity.

The app was developed to make the algorithm more practical for use by physicians and patients. It is the first app for medical and surgical outcomes, said Dr. Heniford.

According to CeQOL, a young asymptomatic patient with no preoperative pain has about a 10% risk for discomfort one year after surgery. Patients with preoperative pain, bilateral inguinal hernias and recurrent hernias have an increased risk of developing chronic pain after surgery.

Interestingly, older patients are less likely tohave symptoms of chronic pain than younger patients.

Dr. Belyansky said the app will help identify high-risk individuals who may benefit from a multidisciplinary treatment approach. “Furthermore, in a preoperative or pretreatment setting, full disclosure of postoperative QOL expectations should become a standard part of the counseling and consent process for surgery and major medical treatments,” he said.

Surgeons at Carolinas currently use the app for all inguinal hernia patients who come into the clinic. Surgeons fill in the app as they speak to patients, or patients do it themselves on an iPad. New products come into the hernia field at rapid speed but data on outcomes follow much more slowly, said Shirin Towfigh, MD, associate professor of surgery, CedarsSinai Medical Center, in Los Angeles,

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Lap Subtotal Gastrectomy Could Be Primary Gastroparesis Therapy Similar Morbidity, Mortality As GES; More Symptom Improvement B Y M ONICA S MITH SAN DIEGO—Gastric electrical stimulation (GES) can improve symptoms in patients with gastroparesis, but after retrospectively reviewing patient outcomes, researchers at the University of Southern California are now offering laparoscopic subtotal gastrectomy to these patients as a primary treatment option.

“Our initial algorithm for patients with medically refractory gastroparesis who needed surgery was placement of a stimulator as a first-line of treatment, and if that fails, a laparoscopic subtotal gastrectomy,” said Joerg Zehetner, MD, assistant professor of surgery in the Department of Surgery, Keck School of Medicine, University of California, Los Angeles, who presented the research at 2012 meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES; S101). “But now, after our study, we think we should tell patients right away that the laparoscopic subtotal gastrectomy also can be seen as a primary therapy because it has a significantly higher rate of symptom improvement, acceptable morbidity and comparable mortality to the GES.” The researchers, led by John C. Lipham, MD, evaluated outcomes in 103 patients who received treatment at their center for medically refractory gastroparesis between January 2003 and January 2012; 72 patients received GES by either laparoscopy (n=20) or miniincision (n=52), and 31 patients received a laparoscopic subtotal (n=27), total (n=1) or completion gastrectomy (n=3). Thirty-day morbidity was significantly greater in the gastrectomy groups than in those who received GES (23% vs. 8%) but this difference leveled out over time; in-hospital mortality was about 3% for both groups.

About two-thirds (63%) of the patients in the GES group achieved symptom improvement as assessed by the Gastroparesis Cardinal Symptom Index, whereas 87% of those in the gastrectomy group reported significant improvement in nausea, vomiting, epigastric pain and other symptoms that plague gastroparesis patients. In the GES group, 19 (26%) had the device removed due to device malfunction, infection or failure to respond; these patients received laparoscopic subtotal gastrectomies, and 100% reported symptom improvement.

Of the patients who failed GES, 80% had diabetesrelated gastroparesis. “This was a little unusual because you would expect those with diabetes gastroparesis to respond better,” than patients with idiopathic or postsurgical gastroparesis, Dr. Zehetner said.

The researchers recommended laparoscopic subtotal gastrectomy as a primary treatment, and to reserve GES for patients who don’t want a gastrectomy or a more invasive procedure. “The good thing about the stimulator is that we can see it as a breaching treatment; it does not prevent us from doing a gastrectomy,” said Dr. Zehetner.

Daniel J. Deziel, MD, Helen Shedd Keith Professor and chair of the Department of General Surgery, Rush University, Chicago, noted there was no statistically significant difference in morbidity and mortality between the

two groups. “One might intuitively think GES a safer approach. Perhaps the number of patients in each group was too small to detect a difference, or this is a seriously compromised patient population to start with,” he said.

“It would be important to know the factors that might predict which patients would be more likely to improve following GES, resection or other procedures that have been used.” Dr. Deziel continued, “Is success related to the etiology of the disease? If we knew this, we might be more effective in our initial therapeutic recommendations, and could perhaps identify patients who would not benefit from any major operative intervention other than jejunostomy placement.”

Researchers from the United Kingdom attempted to answer some of these questions by seeing if placement of temporary GES (tGES) could predict which patients would benefit from a permanent GES. “We know now that GES works, and that it works better in some subgroups,” said N.V. Jayanthi, MD, who presented the research at SAGES (S102). “But we don’t know who fails to improve with GES. So that brings us to tGES.”

condition is so severe that they cannot tolerate oral intake and require jejunostomy tubes. “That is a miserable existence for these patients,” Dr. Sarela said. “For patients with gastroparesis of this sort, the treatment options are very limited.”

As far as the mechanism by which GES works in gastroparesis, “we do not know; it is not as simplistic as it improves gastric emptying, and there have been conflicting studies,” Dr. Sarela said. “We had positive experiences with GES, but one dilemma is that not everyone benefits. It is a fairly straightforward procedure, but still invasive and carries some risk for side effects and complications. It also is very expensive so it’s important to select the patients most likely to have a good response.”

Dr. Sarela’s team set out to see if they could establish a role for tGES in patient selection. Of 71 patients with medically refractory gastroparesis referred to their center, 51 received tGES. “We endoscopically placed an electrode into the stomach lining, which then runs through the patient’s nose and connects to the stimulator on the outside. During the two weeks this is kept in place the patient maintains a symptom diary and we assess how well they do,” Dr. Sarela said.

Overall, 39 (74%) patients improved, and 31 received a permanent GES. At 10 months ‘Lacking other follow-up, 22 (71%) showed significant sustained improvement compared with a 50% tools, tGES is improvement associated with GES in the less invasive and longest series to date (Clinical Gastroenterol Hepatoll 2011;9:314-319). It is not yet clear shows that in whether transmucosal stimulation is equivaselected patients, lent to GES. Also, not all patients tolerate it can improve GES the stimulation, and leads can dislodge inside the stomach without patients or physuccess rate.’ sicians realizing it. “But lacking other tools, —N.V. Jayanthi, MD, tGES is less invasive and shows that in selected patients, it can improve GES sucFRCS cess rate,” Dr. Javanthi said.

Although the results were promising, the follow-up was fairly short. “We have to keep in mind how durable and significant is the clinical response,” Dr. Deziel noted.

Temporary GES: Another Option The improvement was based on patient self-reporting.

The idea of using tGES to predict who will benefit “We didn’t really have any objective physiologic measures from permanent GES is not new. “Dr. Thomas Abell of improvement—it would be interesting to know if they proposed this several years ago,” said Abeezar I. Sare- had any objective data to quantify the effect of the pacla, MD, FRCS, Department of Upper Gastrointestinal, ing on gastric emptying, and whether it is gastric empMetabolic and Bariatric Surgery, St. James’s Universi- tying of solids or liquids and how that correlated with ty Hospital, Leeds, United Kingdom. “But the uptake symptom improvement,” Dr. Deziel said, adding “One on tGES has been quite low.” Dr. Abell’s initial research question I have is why some patients responded to tGES showed a 97% response rate in patients selected by and not GES.” The answer may have to do with differtGES (Digestion 2002;66:204-212). Subsequent research ences between tGES and permanent GES in terms of showed a strong correlation between symptom improve- how electrodes are placed, and perhaps in other differment in tGES and permanent GES (Gastrointest Endosc ence between the two modalities that are not well under2005;61:455-461), and tGES is used as a treatment for stood at this time. nausea and vomiting in patients who do not have gastroRegardless, “there seems to be a good increase in sucparesis (Digestion 2011;83:1-2). cess that we see with tGES,” Dr. Sarela said. “Once we Dr. Sarela has long been interested in GES for gastro- are to the stage of treating someone with GES, we should paresis, a condition he thinks is far too often under- or consider a tGES as a selection parameter.” misdiagnosed. “The vast majority of patients with gasMost important, however, is managing patient expectroparesis are lost among the diagnosis of functional dys- tations. “When they come to our service, they are despepsia,” he said. “I think this is due to lack of awareness. perate and will try anything you want,” Dr. Javanthi said.

But even if we do make a diagnosis of gastroparesis, there “This needs to be carefully managed because if it fails, are few definitive treatments.” they have no other option than a gastric resection.”

The most problematic patients are those who do not Drs. Jayanthi, Sarela and Zehetner reported no disclosures. improve with dietary changes and prokinetics, and whose Dr. Lipham is a consultant for Medtronic.

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25

International Panel Issues Statement on Sleeve Gastrectomy Experts Stress That Recommendations Are Not a Standard of Care; Based on Opinion, Not Randomized Data B Y C HRISTINA F RANGOU

A

n international panel of surgeons with expertise in laparoscopic sleeve gastrectomy has issued a consensus statement on best practices, intended to foster standardization and improve safety for this increasingly popular technique.

“Standardization of the technique of laparoscopic sleeve gastrectomy (LSG) is paramount to improving the safety and maintaining the minimal morbidityy and high g weight loss efficacy rates,” wrotte the authors in their reeport, published in Surrgery for Obesity and Related Diseases (2012;8:8-19).

This marks the T firstt attempt to stand dardize a bariatric/m metabolic surgical proced dure with respect to patient pat selection, technique and complication

‘This represents a snapshot in time and even now, I suspect, some of the conclusions reached remain controversial.’

—Kelvin Higa, MD management based on concurrent best practices, said Kelvin Higa, MD, one of the panelists and clinical professor of surgery, University of California, San Francisco, and director of minimally invasive and bariatric surgery at the Fresno Heart and Surgical Hospital, in California.

“It is intended to serve as a guide for both experienced surgeons and surgeons new to the procedure,” he said.

He cautioned, however, that the document was intended to serve as a guide, and not to dictate standard of care.

The field is changing so rapidly that already some of the recommendations in the statement are outdated. And among recommendations that haven’t been affected by newer data, there was wide variation, in opinions on many items.

“This represents a snapshot in time and even now, I suspect, some of the conclusions reached remain controversial,” said Dr. Higa. “For example, Barrett’s esophagus was felt to be an absolute contraindication (81%); one might argue as to the severity of Barrett’s in relation to other

patient factors such as age and cardiopulmonary risk.”

In recent years, LSG has morphed from its original role as the first step in a two-stage operation for patients with super-morbid obesity to a standalone restrictive bariatric procedure in people with less severe obesity.

Early studies of the procedure as a standalone operation have been “encouraging” but the operation is poorly standardized; long-term results and

randomized studies are lacking.

In March 2011, 27 of the world’s most experienced surgeons in the procedure (all have performed at least 500 LSGs) met to develop a consensus statement that could improve safety and standardization.

Led by Raul J. Rosenthal, MD, professor of surgery and chair of minimally invasive surgery and the bariatric and metabolic institute, Cleveland Clinic Florida, the panel agreed on 69 key recommendations for best practices, based

on their collective experience of more than 12,000 cases.

Consensus was determined by greater than 70% agreement. On most areas of consensus, 90% or more of surgeons supported the statement. The panel could not come to consensus on 26 questions, many on technical areas of stapling and on the role of LSG as a conversion procedure.

Among the recommendations, the panel found that LSG is a valid standalone see CONSENSUS PAGE 27

21st International Congress of the EAES Vienna, Austria 19 - 22 June 2013 HOFBURG

HIGHLIGHTS

Vienna Convention Centre

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Congress President: Prof. Selman Uranues

Program Committee Chair: Prof. Nicola di Lorenzo

Postgraduate courses Hands-on training New technologies “How I do it” video session Challenges in colorectal surgery

- Laparoscopic surgery of solid organs - Diverticular disease

Deadlines: Abstract submission deadline: 15 January 2013 Early registration deadline: 15 April 2013

- Management of complications - Pro and contra discussions

- Role of laparoscopy in advanced rectal cancer -

Robotic surgery Single vs. reduced port surgery Laparoscopy in emergencies Free paper sessions: oral, video and poster

- Special awards and grants - Technical exhibition

To register your interest in the congress simply return the form below to the EAES Office Fax or send it to: EAES Office P.O. Box 335 5500 AH,Veldhoven The Netherlands

Last Name Firt Name Address City + ZIP Code

Phone: +31(0)40 252 5288 Fax: +31(0) 40 252 3102 Email: congress@eaes.eu Internet: www.eaes.eu

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS INTERNATIONAL EDITION 2012

POEM

jContinued from page 1 of Düssseldorf, added that POEM still is considered investigational and many questions need to be answered before it is widely adopted.

Other achalasia experts, however, are more cautious about adopting this treatment, stating that the excitement over the procedure is outstripping the results.

“What I am concerned about is the widespread use of POEM as it is currently being observed without appropriate evaluation of its place in the therapeutic armamentarium for achalasia,” said Carlos Pellegrini, MD, Henry N. Harkins Professor and Chair, Department of Surgery, University of Washington School of Medicine, after results of a new study were presented at the annual meeting of the American Surgical Association (ASA) this spring. “All too often, we have seen rapid adoption of new procedures simply because they are new, procedures that eventually fade away from practice after [a] considerable price has been paid by society.”

The Rise of POEM In 2007, Pankaj Jay Pasricha, MD, and colleagues reported that they had performed an endoscopic method of esophageal myotomy in animal studies (Endoscopy 2007;39:761-764). Soon after, Japanese surgeon Haruhiro Inoue, MD, performed a peroral endoscopic myotomy Peroral endoscopic myotomy is a potentially promisin humans who had achalasia and other spastic esoph- ing approach to treat achalasia and esophageal motility ageal motility disorders (Endoscopyy 2010;42:265-271). disorders, but some experts warn that it is not yet ready Since then, the procedure has been picked up around for widespread adoption. the world and the video presentations usually create a Image courtesy of Haruhiro Inoue, MD stir when presented at surgical meetings.

To date, the exact numbers of patients who have The New Research undergone POEM worldwide are unknown. Published reports suggest about 300 patients in China, 200 in This spring, several of the centers most experienced Japan, 70 in Europe and 100 in the United States have with POEM around the world presented their updathad the procedure. Additionally, many surgeons and ed results. In one trial, European investigators presentgastroenterologists worldwide have undergone some ed early data from the first prospective international training in POEM even if they do not yet perform it trial of POEM, which included 51 patients with priin their practice. Training programs mary achalasia (29 men; mean age, are available in Japan, the United 43 years) who underwent POEM ‘POEM is a promising States and Europe. at centers in Germany, SwitzerTechniques around the world treatment for achalasia land, the Netherlands and Canada. vary but most follow the same prinPOEM was successfully performed with adequate symptom in ciple: After the patient goes under all patients with a mean operative general anesthesia, the endoscopist relief in 90% of cases.’ time of 105 minutes. A transmural makes a small incision in the muco—Daniel von Renteln, MD esophageal perforation at the mucosa of the esophagus, approximately sal entry site occurred in one patient; 15 cm above the gastroesophageal the perforation was addressed intrajunction. The endoscopist then creoperatively and the patient had no ates a tunnel into the submucosal space, reaching down further sequelae. Two patients developed ulcerations to the gastroesophageal junction. A long endoscopic (one at the esophagus and one at the cardia) within myotomy of inner circular muscle bundles is carried out, a month of the procedure. These complications also leaving the outer longitudinal muscle layer intact. When resolved without sequelae. the procedure is finished, the small opening in the mucoThe investigators provided some data on threesal lining is clipped. month outcomes, in the longest follow-up yet availOnly about eight reports of POEM have been pub- able for POEM. In 35 patients followed for at least lished, most of them small and from single centers. three months postoperatively, 94% had an Eckhardt The largest series comes from China and includes 119 score drop of three points or greater, which investipatients. In the studies to date, there are no reports of gators defined as a treatment success. Mean lower patient deaths. But unconfirmed reports have circulated esophageal sphincter pressure dropped from 27.4 that a 19-year-old woman in the United States may have mm Hg pretreatment to 10.2 mm Hg post-treatment died following a POEM procedure. The woman died (P<0.001). in a Baltimore hospital from mediastinal sepsis secondHowever, POEM also appeared to be associated ary to a perforation. Before her death, she told hospital with an increased risk for reflux at a rate similar to staff that three days earlier she underwent an endoscop- that for other conventional achalasia treatments; 20% ic Heller myotomy. The hospital has released no further of patients developed symptoms of gastroesophageal details. It’s not known if the woman indeed underwent reflux post-treatment.

POEM or if she had a laparoscopic Heller myotomy.

This finding may contradict one of the chief

arguments for POEM, namely that it may avoid the risk for reflux commonly associated with conventional achalasia treatments because it leaves intact the anatomy of the lower esophageal sphincter. This study suggests that the reflux rate after POEM is comparable to that of balloon dilation and perhaps even laparoscopic Heller myotomy with fundoplication. Although many experts usually cite reflux rates of 10% to 15% after Heller myotomy with fundoplication, some large published studies indicate that between 21% and 42% of patients experience post-treatment reflux (Surg Endosc 2012;26:18-26; Arch Surgg 2005;140:827-833). Additionally, 17% of patients had erosive esophagitis on follow-up esophagogastroduodenoscopy.

If POEM does not reduce reflux rates compared with laparoscopic Heller myotomy, there is little reason to pursue it, said Marco Patti, MD, professor of surgery and director of the Center for Esophageal Diseases, University of Chicago Pritzker School of Medicine. “In my mind, what do you gain? You avoid the four 4-mm incisions that you use for a laparoscopic Heller myotomy with a fundoplication. That’s all.

And for a procedure that only has very short-term follow-up.”

He said he is not surprised by the high rate of reflux.

“When you do a POEM, you just cut all the muscles and you open completely the valve, so whatever else is in the stomach will actually reflux.”

The investigators, however, said that the results suggest there is a role for POEM in the treatment of achalasia. “POEM is a promising treatment for achalasia with adequate symptom relief in 90% of cases,” said lead author Daniel von Renteln, MD, of the Department of Interdisciplinary Endoscopy, University Medical Center Hamburg-Eppendorf in Hamburg, Germany, adding that further studies are warranted to evaluate long-term efficacy.

In a single-center study, presented at the ASA’s annual meeting, Lee Swanstrom, MD, a surgeon in the minimally invasive surgery division at The Oregon Clinic, in Portland, and colleagues looked at sixmonth results in 18 patients who underwent POEM. The group included nine women and nine men with manometrically defined achalasia who were eligible for laparoscopic myotomy. The cohort had a median ASA of 2, experienced symptoms for a median of 25 months and lost a median of 12 pounds prior to POEM. Ten patients had advanced achalasia (Eckhardt score greater than 6) and 11 had prior endoscopic interventions.

The procedures lasted a median of 146±44 minutes and the median length of the myotomy was 9 cm with a median six clips used for mucosotomy closure.

Like the European investigators, Dr. Swanstrom and colleagues reported high rates of reflux, this time reaching 46%, based on 24-hour pH tests. The reflux was categorized as mild to moderate in all patients.

The implications of the acid reflux on long-term results are not yet determined, said Dr. Swanstrom.

Patients who were shown to have reflux were started on peptic medications even if they were asymptomatic.

The study also showed that POEM was associated with a significant reduction of achalasia symptoms. In post-procedural exams, patients experienced improvements in dysphagia and lower esophageal sphincter pressure, measurable one month after surgery and still present up to six months after POEM. Additionally, patients had very low pain levels after treatment; only two of 18 (11%) required any pain medication following POEM. They returned to full activities within a mean of three days, investigators reported.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS INTERNATIONAL EDITION 2012

One patient did experience a major complication, P<0.0001), and use of forceps also declined by twoa full-thickness entry incision. Surgeons recognized thirds (0.96±1.4% vs. 2.4±2.5; P=0.045).

P the problem immediately and placed a single endoThe investigators, led by Zhou Pinghong of the scopic suture to close at the end of the procedure. The Endoscopy Center, Zhongshan Hospital of Shanghai’s patient experienced no ill effects as a result, said Dr. Fudan University, reported no perforations or surgical Swanstrom. Minor complications included five cases intervention in either group. The length of the mucoof capnoperitoneum, one capnosa cut, the length of the circuthorax and four mucosotomies. muscle cut and the number of ‘My gut feeling is that it is lar The study provides “the first hemostatic clips used were similar objective evidence that the absolutely unethical to do between the two groups.

POEM procedure is a safe and this procedure outside of Future for POEM effective surgical treatment for achalasia palliation,” said Dr. IRB protocols in tertiary care Achalasia experts want more Swanstrom. He stressed that the long-term and well-designed studcenters, where they will procedure is a surgical treatment ies before the procedure gains performed endoscopically, and have long-term follow-up.’ further acceptance. Dr. Pellegrishould be performed by surgeons ni said that past experiences with —Marco Patti, MD experienced with endoscopy and botulinum toxin and other treatachalasia. ments demonstrate the need for In another study, presented at Digestive Disease long-term follow-up. Botulinum toxin had excellent Week 2012, Chinese surgeons unveiled a new approach results at six months but was later found to fail withto POEM in which they performed a water-jet in two to five years (Nat Rev Gastroenterol Hepatol hydrodissection. They used a HybridKnife (Erbe, Ger- 2011;8:311-319). many), a single instrument that combines an ultrafine “It is not until we have a follow-up of at least several high-pressure water jet with an electrocautery needle. years that we can say that a treatment modality is effecThe surgeon used the water-jet function to perform a tive in this disease,” Dr. Pellegrini said. needleless submucosal injection, and switched to the Dr. Patti said he is concerned that the technique is electrosurgical function for submucosal tunneling and being widely adopted prematurely. In recent months, endoscopic myotomy of inner circular muscle bundles. he received phone calls from other physicians looking In the randomized controlled study of 43 patients for referrals so they can perform POEM on patients. who underwent water jet–assisted POEM or conven- Dr. Patti said he has refused to refer patients to surtional POEM, the authors found that water jet–assist- geons and gastroenterologists who do not have a proved POEM was associated with a significantly shorter en record with both achalasia and POEM. operating time, lower bleeding rate and a reduced use “Unfortunately, outside of the centers where it is of coagulation forceps. Operating time decreased by 15 done with IRB [institutional review board] approval, minutes with the water-jet approach, from 36.9±10.0 centers are not explaining that this is experimental and to 21.8±7.1 minutes (P<0.0001). The bleeding that we really don’t know the results. Dr. Swanstrom rate fell by two-thirds (4.8±1.3% vs. 12.5±4.9%; is a very skilled endoscopist and surgeon, and yet even

CONSENSUS

jContinued from page 25 procedure and a valid option for high-risk patients, transplant candidates, morbidly obese patients with metabolic syndrome, patients with a body mass index of 30 to 35 kg/m2 with associated comorbidities, patients with inflammatory bowel disease and adolescent morbidly obese patients.

The panel just missed agreement on the statement “LSG will become the most frequently performed [bariatric/ metabolic] procedure,” although 67% supported the position.

Panelists were highly divided on many issues regarding revisions. They did not agree that LSG is a valid option to convert a failed laparoscopic adjustable gastric band (67%). Consensus was reached on the point that Roux-enY gastric bypass, not LSG, is the best option to convert a failed gastric band but with only 71% of surgeons in agreement. Most members of the panel, 95%, said that LSG is an “acceptable option to convert a successful but complicated gastric band” but only 72% said that it can be done in a single step.

The panel came to agrreement on optimal bouggie size, saying that a bou ugie between 32 and 36 Fr (87%) is ideal. They cau utioned that a bougie less than 32 Fr might increaase complications and a boougie larger than 36 Fr could lead d to a llackk of long-term restriction and possible dilation of the sleeve.

Studies presented since the panel’s consensus suggest that bougie size can be larger than 36 Fr, said Michel Gagner, MD, clinical professor of surgery in Montreal. Two meta-analyses presented at the International Federation for the Surgery of Obesity and Metabolic Disorders meeting in September 2011 showed that bougie size below 40 Fr resulted in higher rates of leaks and bioabsorbable buttress material had decreased the rate of leaks by threefold.

“I would suggest surgeons should use a bigger bougie size than in the consensus statement,” said Dr. Gagner.

The panel agreed that staple-line reinforcement reduces bleeding along the staple line (100%). And 95% of the panel said

he has a high rate of complications,” Dr. Patti said.

“My gut feeling is that it is absolutely unethical to do this procedure outside of IRB protocols in tertiary care centers, where they will have long-term followup. Second, it should be done by a multidisciplinary group that involves a surgeon, a gastroenterologist and a radiologist.”

Dr. Neuhaus believes that it’s too early to make a decision about POEM but it may yet have a role in future achalasia treatment. He said that POEM may eventually prove most effective for patients who have failed more conventional treatments for achalasia and those likely to have poor results with laparoscopic myotomy or pneumatic dilation, primarily younger patients or patients with type III achalasia.

But he too cautioned that many important questions must be answered in clinical trials before POEM is broadly accepted. The predictive factors for failure have to be determined; long-term outcomes must be studied; and the sequelae of reflux after POEM need to be investigated. Even if POEM results hold up in the long term, he said, “these procedures should be limited to centers with expertise in advanced therapeutic endoscopic and/or laparoscopic surgery, and should be done on an interdisciplinary level with well-chosen patients in carefully designed clinical trials.”

Dr. Renteln reported no relevant disclosures. Other investigators involved with the European trial reported relationships with Olympus, Torax Medical, Boston Scientific Corporation, Cook, Inc., Movetis NV, AstraZeneca, Erbe GmbH and Karl Storz. Dr. Swanstrom reported relationships with Boston Scientific and Olympus Medical. No other surgeon quoted in this article reported having relevant disclosures.

it is accceptable to oversew and 77% said it is acceptable to buttrress the staple line.

Acccording to the panel, staplee heights are still up for deebate. They agreed that stapless should not be used with a cclosed height less than that h off a blue bl load (1.5 mm) on any part of a sleeve gastrectomy (81%).

They suggested that nothing less than a green load up to the incisura angularis, nothing less than blue from the incisura angularis to the angle of His and nothing less than green when performing revisions should be used.

The authors stressed that it is important to completely mobilize the fundus before transection (96%) and to take down short gastric vessels before resection (82%).

On the issue of leaks, the panel widely agreed that Roux-en-Y reconstruction is a valid treatment option in proximal chronic leaks (90%), while stenting has limited utility for chronic leaks (86%). Stents can be used for an acute proximal leak (93%).

Dr. Gagner warned that the statement represents expert opinion, and not

randomized data. Expert opinion is rated as the lowest level of evidence-based medicine at level 5, he said. “An expert opinion is just an expert opinion and an expert opinion of 20 experts is just an expert opinion of 20 people.”

“This statement is out there just to help practitioners know what the experts are thinking about sleeve gastrectomy at a particular moment.”

He added, “I would suggest that surgeons don’t need to concentrate on making the most perfect sleeve and aiming for radical weight loss for their patients; I think they should concentrate on making the sleeve in the safest way possible, not getting any strictures and avoiding leaks should be their No. 1 concern.”

Dr. Rosenthal said he and his colleagues are working on a second publication on LSG that will be based on data from the 12,799 cases submitted to the consensus panel.

The Centers for Medicare & Medicaid Services (CMS) currently restricts coverage for LSG. In fall 2011, CMS announced it is reviewing available evidence on the use of LSG for the treatment of morbid obesity.

27

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REPORT Benefits of GORE速 DUALMESH速 Biomaterial in Hernia Repair: A Case-based Presentation

Introduction from the Faculty Chair Karl LeBlanc, MD Baton Rouge, Louisiana Considered one of the most common types of surgery, hernia repair remains an ongoing challenge for surgeons because

Chair Karl LeBlanc, MD Associate Medical Director Surgeons Group of Baton Rouge/Our Lady of the Lake Physician Group Director and Program Chair of the Fellowship Program Minimally Invasive Institute Adjunct Professor Pennington Biomedical Research Center Baton Rouge, Louisiana Clinical Professor of Surgery Louisiana State University New Orleans, Louisiana

of the risk for recurrence and other complications.1 As a long-standing material used for hernia repair, expanded polytetrafluorethylene (ePTFE) has made strides to maximize the outcomes and address the risks. The use of ePTFE has evolved significantly since its introduction in 1983.2 With early iterations, such as the GORE-TEX速 Soft

Faculty

Carl R. Doerhoff, MD

Srdjan Rakic, MD

Alfredo M. Carbonell, DO

General Surgeon SurgiCare of Missouri Jefferson City, Missouri

Staff Surgeon Department of Surgery Twenteborg Hospital Almelo, The Netherlands

Chief of Minimal Access and Bariatric Surgery Co-Director, The Hernia Center Associate Professor of Clinical Surgery Greenville Hospital System University Medical Center University of South Carolina School of Medicine Greenville, South Carolina

Birgitta Hansson, MD Department of Surgery Canisius-Wilhelmina Hospital Nijmegen, The Netherlands

Antonio Iuppa, MD Chief, Department of Surgery Istituto Oncologico del Mediteraneo Viagrande, Italy

Supported by

Songzhang Ma, MD Professor of General Surgery Beijing Redcross Chaoyang Hospital Capital Medical School Beijing, China

REPORT Tissue Patch (GORE®, W.L. Gore & Associates, Inc.), surgeons could apply a solid, microporous sheet of ePTFE to enhance tissue incorporation while minimizing the risk for recurrence.3 With more recent configurations of ePTFE, particularly GORE® DUALMESH® Biomaterial and GORE® DUALMESH® PLUS Biomaterial (GORE®, W.L. Gore & Associates, Inc.), hernia repair has become more innovative, improving fixation to the abdominal wall and tissue ingrowth, while minimizing adhesion formation and the risk for recurrence.4 Despite these developments, there are several misconceptions regarding its use and longterm outcomes, as well as the costs associated with the ePTFE material. In the past, several publications provided relevant information on the use of ePTFE, but as with many maturing prosthetic materials, surgeons may be overlooking the benefits of this long-standing material when compared with other prosthetics, such as polypropylene and polyester mesh.5 Yet, with studies demonstrating an increased risk for recurrence as well as biomaterial-related complications—adhesion formation and tissue ingrowth—and bowel obstruction when using polypropylene and polyester mesh, understanding how to use ePTFE in hernia repair for different types of patients will increase awareness of the features that continue to make ePTFE the most effective option.6,7 This report will discuss the benefits of using GORE ® DUALMESH® Biomaterial in hernia repair and provide evidence based on recent studies as well as clinical experience.

Understanding the Mechanism Behind ePTFE ePTFE is a fluorocarbon polymer with favorable properties— chemical inertness, a high strength-to-weight ratio, thermal resistance, and biocompatibility—that can be expanded and manipulated to modulate tissue response.8 The fluorine atoms shield the carbon atoms, resulting in a low level of reactivity with other chemicals. Consequently, there cannot be chemical cleavage of the bonds or covalent chemical interactions.9 The strength of the fluorocarbon bonds is an underlying characteristic of ePTFE mesh. The mesh can be placed either by laparoscopy or by an open surgical approach. Unlike sutures, mesh repair minimizes the risk for recurrence and postoperative pain, and is associated with greater patient satisfaction.10 If adhesions occur, the bowel easily can be dissected free from the prosthesis without affecting other tissue or neighboring organs.11,12 Although conventional ePTFE mesh is pliable and can provide effective tissue ingrowth while minimizing inflammation and adhesion formation,5,13 the GORE® DUALMESH® Biomaterial product possesses a smooth surface on the visceral side that mitigates against the development of adhesions to the material. The CORDUROY surface allows for rapid tissue ingrowth. Every surgeon is concerned about the risk for developing a prosthetic infection.

The GORE® DUALMESH® PLUS Biomaterial product is the only product on the market that has antimicrobial agents impregnated within it. This has been proven to be an effective agent against methicillin-resistant Staphylococcus aureus (MRSA)14 for up to 14 days postoperatively.

Characteristics of the GORE® DUALMESH® Biomaterial The GORE® DUALMESH ® Biomaterial currently is used in hernia repair—open and laparoscopic—and temporary

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bridging of fascial defects.15 Unlike its ePTFE predecessors, as well as other meshes—polypropylene- and polyester-based— the GORE® DUALMESH® Biomaterial possesses a 2-sided design with one side to promote ingrowth, while minimizing adhesions on the other.4,16 The GORE® DUALMESH® Biomaterial features a visceral interface side with pores less than 3 microns in size that minimize tissue attachment, and a fascial side—the CORDUROY surface—that includes ePTFE ridges that stimulate tissue fixation on the abdominal wall to create a neoperitoneal surface.4 The GORE® DUALMESH® Biomaterial is soft and supple, allowing it to roll up tightly enough to be inserted into the abdominal cavity with or without the use of a trocar.17,18 In the event that the patient requires radiation therapy subsequent to the hernia repair, ePTFE is able to withstand therapeutic irradiation.19 The GORE® DUALMESH® Biomaterial is the only consistently visible mesh on computed tomographic (CT) scans, which provides a benefit for future evaluations of the abdominal wall to assess the need for any additional surgical interventions.20

Minimizing Adhesion Formation in Hernia Repair The barrier surface of the GORE® DUALMESH® Biomaterial is permanent and proven. One study evaluated the severity of adhesions using GORE® DUALMESH ® Biomaterial at reoperation (N=65), and found that 91% of patients had filmy, avascular adhesions if they had any at all.12 If one has had the opportunity to reoperate on a patient who had undergone mesh implantation, the challenge of minimizing adhesion formation to these materials is not widely publicized. These have proven to be most difficult in many patients regardless of the “tissue-separating” product being used; however, this is not the case with the GORE® DUALMESH® Biomaterial. In cases where patients require reoperation, clinicians are able to see the neoperitoneum on the visceral surface of the material.12 This layer is easily penetrated to expose the underlining ePTFE surface that will appear as pristine as the day of implantation.

This layer can be dissected from the mesh so that there is minimal risk for bowel injury.12 This represents a unique quality of the material that is largely unrecognized.

Improving Recurrence Rate With GORE® DUALMESH® Biomaterial Recurrence is considered the most important end point in hernia repair.20 With recurrence rates as high as 58%,21 surgeons have benefited from the use of laparoscopy in ventral and incisional hernia repair. Heniford et al evaluated the safety and efficacy of laparoscopic ventral hernia repair in 850 patients of which 34% were recurrent hernias. GORE® DUALMESH® Biomaterial was used in 97% of patients, and the results showed a recurrence rate of 4.7% in patients at mean follow-up time of 20 months.22 Additionally, patients experienced a shorter hospital length of stay (LOS, 2.3 days) and a low conversion rate to open surgery (3.4%).22 Similarly, Cobb et al conducted a retrospective study (N=270) to evaluate laparoscopic ventral and incisional repairs using GORE® DUALMESH® Biomaterial.17 The average patient was obese and had a large hernia (143 cm2).17 Results showed that the recurrence rate for ventral hernias was 4.7% and that laparoscopic ventral hernia repair was associated with shorter LOS (3 days) and a low rate of conversion to open surgery (2.5%).17

REPORT The strength of the ingrowth of the collagen into the product is considered critical to the prevention of recurrence of herniation following the repair of these hernias with GORE® DUALMESH® Biomaterial. This has been confirmed in the laboratory. One study evaluated the use of GORE® DUALMESH® Biomaterial versus polypropylene mesh in 12 rabbits and assessed adhesions, and found that it had greater attachment strength (P=0.02).4 Additionally, the study showed that 12% of the rabbits in the GORE® DUALMESH® Biomaterial group developed adhesions on the visceral side compared with 88% of rabbits in the polypropylene group.4

Minimizing Infection With GORE® DUALMESH® PLUS Biomaterial In addition to hernia recurrence, one of the ongoing concerns of using prosthetic materials is the infection rate associated with hernia repair. Hospital-acquired infections, including surgical site infections, continue to be challenging, and result in increased patient pain and discomfort, longer hospital LOS, and a higher mortality rate; thus, it is imperative to identify strategies that will minimize the risk for infection while optimizing the outcomes.23 Hernia repair and the use of biomaterials presents a higher potential for infection and, consequently, an increased recurrence rate. Studies show that although infection rates vary depending on whether procedures are open or laparoscopic, rates can be as high as 18%.24 In cases where patients are more susceptible to infection, GORE® DUALMESH® PLUS Biomaterial has been proven effective in inhibiting bacterial colonization, while maximizing rapid tissue attachment. GORE® DUALMESH® PLUS Biomaterial is the only prosthetic material for hernia repair that incorporates an antimicrobial agent within the product.17 The GORE® DUALMESH ® PLUS contains both silver carbonate and chlorhexidine diacetate, which have been shown to be bactericidal to 10 different strains of organisms including MRSA, S. epidermidis, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Candida albicans.25 Harrell et al tested MRSA resistance in 9 types of mesh, including GORE® DUALMESH ® PLUS Biomaterial,

Parietex ® Composite (polyester/polypropylene/glycol), Marlex® (polypropylene), and Composix® (ePTFE/polypropylene), and found that GORE® DUALMESH® PLUS Biomaterial was the only mesh without detectable adherence by MRSA.14 The impregnation of these agents into the biomaterial provides protection against the risk for an infection by inhibiting microbial colonization and initial biofilm formation for up to 14 days following repair.14

Clinical Evidence on Lack of Shrinkage For GORE® DUALMESH® Biomaterial GORE® DUALMESH® Biomaterial continues to be a mainstay of laparoscopic incisional and ventral hernia repairs. Yet, there has been criticism of the material in that there is a perception that it shrinks more than other materials used for this type of procedure. Recent studies have provided data on adult patients that address this misconception. Because ePTFE is the only prosthetic consistently visible using CT imaging,26 Carter and colleagues were able to measure the size of the mesh after implantation in 65 patients undergoing CT scanning following laparoscopic incisional hernia repair with GORE® DUALMESH® Biomaterial.27 It was possible to determine the actual size of the mesh after implantation using specialized software, which showed an average shrinkage rate of 7.9%.27 Similarly, Schoenmaeckers et al reported that shrinkage of ePTFE in 656 patients undergoing laparoscopic hernia repair was only 7.5% when measured by CT scan.26 Since the introduction of the ePTFE, a number of studies have outlined its characteristics and demonstrated its use for hernia repair in optimizing outcomes in different types of patients. This report will address many of the current uses of GORE® DUALMESH® Biomaterial, including parastomal hernia repair, re-operative procedures in the presence of mesh, and complex abdominal wall repairs. Certainly, there are many surgeons who do not believe that a product is better just because it is new. More importantly, however, the science as well as a product’s track record should provide guidance when selecting a prosthetic material to repair any and all hernias.

Case 1 An 85-year-old man undergoing parastomal hernia repair.

Alfredo M. Carbonell, DO

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he patient had a history of invasive bladder carcinoma. Twelve years ago, the patient had undergone a radical cystoprostatectomy with an ileal conduit urinary stoma. He presented with both a midline incisional and a recurrent parastomal hernias. He had undergone 2 failed open non-mesh attempts at parastomal hernia repair in the past ( Figure 1). After discussing open and laparoscopic options, the patient chose laparoscopy.

A laparoscopic Sugarbaker repair was performed. Taking into account the midline incisional defect, the hernia defect area measured 11 x 9 cm (Figure 2). The GORE® DUALMESH®

Figure 1. Computed tomographic scan image demonstrating both the parastomal and midline incisional hernia defects.

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REPORT Biomaterial was chosen for the repair as it is the most proven mesh for the laparoscopic repair of parastomal hernias, and its laminar mesh structure prevents an aggressive mesh–bowel inflammatory reaction, thus preventing bowel erosion.28 The GORE® DUALMESH® Biomaterial was trimmed to a size measuring 18 x 21 cm. Cardinal sutures were placed along the edges of the mesh and paired sutures were placed along the side of the mesh where the bowel would exit (Figure 3). The mesh was positioned against the abdominal wall using both permanent sutures and tacks (Figures 4 and 5). Total operative time was 98 minutes, and postoperatively the patient did very well and was discharged home after a 4-day hospital stay. At the 4-year follow-up, the patient remained free of cancer and without any recurrence.

Discussion The laparoscopic Sugarbaker parastomal hernia repair is a durable hernia repair option. The physical properties of GORE®

DUALMESH® Biomaterial with its laminar construction make it the safest mesh to use for this technique and this has been borne out in the clinical literature.16,28 Parastomal hernias pose a unique problem for general surgeons because unlike other types of hernias of the abdominal wall, the defect needs to be covered completely while still allowing a functional portion of the intestine to exit the abdominal wall through that very same defect. The Sugarbaker parastomal hernia repair technique accomplishes this task by positioning the mesh directly against the abdominal wall, while allowing the bowel segment to course in between the mesh and the abdominal wall. The bowel then re-enters the peritoneal cavity through a sling or shower curtain deformity between the mesh and the abdominal wall. Because the bowel essentially is draped over the edge of the mesh, the mesh has to have certain properties to avoid mesh–bowel erosion.

Conclusion For years, GORE® DUALMESH® Biomaterial has been the most consistently used type of mesh for laparoscopic incisional hernia repair as well as parastomal hernia repair, particularly,

Figure 4. GORE® DUALMESH® Biomaterial in position against the abdominal wall.

Figure 2. Intraoperative photo demonstrating the parastomal hernia defect.

Figure 3. GORE® DUALMESH® Biomaterial with cardinal sutures in place prior to implant.

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Figure 5. Immediate postoperative photo demonstrating the laparoscopic incisions and the transabdominal fascial suture site incisions.

REPORT the Sugarbaker technique.28,29 GORE® DUALMESH® Biomaterial is a nonporous, laminar mesh structure, which allows for adequate mesh ingrowth, without the dense adhesions seen with other mesh types.30,31 Although the macroporous or corduroy side of the mesh is placed in direct contact with the bowel, the mesh does not erode into the bowel. Despite its many years of use, there have been no reported events of spontaneous GORE ® DUALMESH ® Biomaterial–bowel erosion as have been seen with both polyester and polypropylene-based meshes.32 Its laminar structure prevents the mesh from growing into the bowel, despite the continuous peristalsis of the bowel across the mesh edge.

Q&A Dr. LeBlanc: Do you prep the bowel in these patients?

Dr. Carbonell: No. A bowel prep is traditionally used to decrease the chance of wound infection or anastomotic leaking at the time of bowel resection or reanastomosis. Not only have studies demonstrated the opposite to be true, but we also

are not opening the bowel during parastomal hernia repair. If one was to injure the bowel during the repair, it would be inadvisable to proceed with mesh implantation anyway. Hence, bowel prep is not useful.

Dr. LeBlanc: How far apart are the sutures placed?

Dr. Carbonell: We have traditionally used a spacing of every 5 cm or so for standard laparoscopic incisional hernia repair, the thought being that if the mesh stays where you place it, the hernia is unlikely to recur. The only way to ensure that the mesh stays where you place it is to use multiple, permanent, transabdominal fascial sutures.

Dr. LeBlanc: Do you place an abdominal binder on these patients postoperatively? If so, how long do you make them wear it?

Dr. Carbonell: Binders have not been shown to decrease seroma, but in some patients it helps them feel like they have support of their abdomen while they ambulate. If the binder is comfortable for them, I have these patients wear it for support for approximately 6 weeks.

Case 2 A 39-year-old man with a large recurrent midline incisional hernia.

Carl R. Doerhoff, MD

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he patient was morbidly obese with a body mass index (BMI) of 40 kg/m2 (height: 68 inches, weight: 120 kg). A construction worker, the patient was on medical disability. Significant past medical history included a prior colostomy and subsequent subtotal colectomy with J-Pouch for ulcerative colitis in 1998. He reported having 15 abdominal operations with multiple attempts at hernia repair, including multiple mesh failures. In 2009, he underwent a repair using the components separation technique with polypropylene but he developed yet another recurrence. He had a second repair using the components separation technique in early 2010 using biologic mesh. Following this operation, he developed a large wound infection that was treated with damp-to-dry dressings and healed by secondary intention.

When the patient was referred and first examined in July 2010, he had a large abdominal wall defect, an exceedingly thin, weeping re-epithelialized wound, and a central “mass” of contracted polypropylene measuring 2 x 8 inches. His CT scan showed a meshoma with surrounding inflammation.

In August 2010, the patient underwent operation to remove the infected polypropylene and biologic mesh and excise the thin re-epithelialized skin. The patient’s midline incisional defect and left-sided colostomy hernia were closed using a No. 1 absorbable monofilament. The incision was left open; however, despite negative pressure wound therapy and dampto-dry dressings, the wound continued to have a draining sinus tract. In November 2010, the patient underwent operation to remove an infected polypropylene stitch. This time, his wound healed with damp-to-dry dressings. A follow-up CT scan showed no residual mesh or inflammation but did show an abdominal wall defect measuring 22 x 32 cm. The residual

Figure 6. Large recurrent midline incisional hernia repaired using 2 pieces of GORE® DUALMESH® PLUS Biomaterial (26 x 34 cm).

abdominal wall could not be medialized to decrease the size of his defect. Consequently, the defect had to be bridged with a piece of mesh that could withstand significant intraabdominal pressure and protect abdominal viscera.

In February 2011, the patient’s hernia was repaired laparoscopically, using 2 pieces of GORE® DUALMESH ® PLUS Biomaterial, each measuring 26 x 34 cm. The first 2.5 hours of the procedure required extensive adhesiolysis. The falciform ligament was taken down and the urinary bladder was mobilized posteriorly. Outside the abdomen, the 2 pieces of GORE® DUALMESH® PLUS Biomaterial were oriented transversely, overlapping by 5 cm, and affixed to one another with 22 interrupted stitches of CV-0 GORE-TEX® Suture (Figure 6).

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REPORT Cardinal stitches of CV-0 GORE-TEX® Suture were placed at 6 locations on the mesh. The conjoined pieces of mesh were introduced into the abdomen through a 15-mm trocar site. Cardinal stitches were brought transabdominally, using a GORE® Suture Passer. The edge of the mesh was then positioned using an absorbable tacker. The caudal portion of mesh was affixed to the pubis and Cooper’s ligaments with a nonabsorbable tacker. Next, 25 transfascial CV-0 GORE-TEX® Sutures were placed circumferentially around the 2 pieces of mesh using a GORE® Suture Passer. Last, a double crown of 300 nonabsorbable tacks was placed circumferentially. All skin incisions were closed using running nonabsorbable sutures.

The entire operation was completed in 5 hours. The patient had an uneventful hospital course and was discharged on postoperative day 5.

Conclusion This operation demonstrates that bridging is still a viable alternative even for the largest of multiple recurrent hernias.

Q&A Dr. LeBlanc: Do you attempt to make the obese patients lose weight prior to surgery?

Dr. Doerhoff: Typically, yes. Especially if they have failed more

than one repair or if their BMI is greater than 45 kg/m2. Studies have shown that the recurrence rate in the obese population can be as high as 50%. Although some patients refuse to lose weight, a durable laparoscopic repair can be done.

Dr. LeBlanc: Why did you choose the laparoscopic approach rather than an open approach to this hernia?

Dr. Doerhoff: I’m not a personal fan of open repair because of increased risk for infection, seroma, and wound complications.

The laparoscopic repair allows me to visualize the complete abdominal wall and identify any additional smaller hernias, as well as “Swiss cheese” defects. Therefore, I do a better job of overlapping a defect laparoscopically. Additionally, studies of incisional hernias have shown that covering the entire prior incision may reduce recurrence.

Dr. LeBlanc: Do you think that the PLUS product was the ideal product for this individual and why?

Dr. Doerhoff: I always feel better adding an antimicrobial barrier (silver and chlorhexidine) to the mesh in a patient who has had a previous mesh infection. Additionally, studies have shown a higher incidence of wound infections in the obese population.

The antimicrobial technology has been shown to be effective against both gram-positive and gram-negative bacteria as well as MRSA for up to 14 days postoperatively.

Case 3 A 66-year-old obese woman undergoing parastomal hernia repair.

Birgitta Hansson, MD he patient had a BMI of 33 kg/m2 and suffered from rheumatoid arthritis. The latter was treated with steroids. Five years ago, a Hartmann’s procedure was performed to manage acute diverticular disease with perforation and peritonitis. The patient complained of pain caused by the stretching of the abdominal wall and poor fitting of the appliance, resulting in leakage and peristomal skin irritation.

Furthermore, she reported to have cosmetic problems that caused her quality of life to decrease significantly since the hernia became symptomatic. Clinical examination showed a huge parastomal hernia in the left lower abdomen. The hernia could not be reduced.

A CT scan was performed to measure the hernia and rule out concomitant incisional hernias because these could not be palpated at clinical examination. The results showed a hernia of more than 5 cm with herniation of the small bowel and an incisional hernia in the lower abdomen (Figure 7). Because of her growing complaints, a laparoscopic approach was determined to be optimal, and both hernias were repaired using 2 separate pieces of GORE® DUALMESH® Biomaterial. The parastomal hernia was repaired using the Sugarbaker technique, by which the mesh covered the hernia opening with an overlap of 4 cm on each side once the stoma loop was lateralized. The double crown technique was used for the incisional hernia. The postoperative course was uneventful. Figure 8 shows the postoperative result after the Sugarbaker technique.

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Discussion A parastomal hernia is a common complication after stoma formation. Risk factors are obesity, chronic cough, or when the created size of the stoma opening is too wide. A symptomatic parastomal hernia can be treated by relocating the stoma, or by local reinforcement of the abdominal wall with a prosthetic mesh. Stoma relocation involves relaparotomy and replacement of the stoma to the contralateral side. In addition to the risk for developing an incisional hernia at the midline or at the old ostomy site (20%-30% of all cases), this technique carries a recurrence rate of up to 36%.33,34 Mesh repair has a lower recurrence rate. Depending on technique and placement, recurrence rates vary between 6.9% and 17.8%, and the overall mesh infection rate is 2.3%.28 The mesh can be placed in an onlay, retromuscular, or intraperitoneal position, either by laparoscopy or open approach. A review of the literature finds no significant advantage of one approach over the other, while randomized controlled trials have proven to be lacking.28 The laparoscopic approach is safe and feasible and causes minimal damage to the insufficient abdominal wall.35 GORE® DUALMESH® Biomaterial is used to reinforce the abdominal wall. GORE® DUALMESH® Biomaterial is the most often used prosthetic material in parastomal hernia surgery because it is soft and pliable and easy to handle. It results in less severe adhesions to the viscera compared with polypropylene meshes.16 If adhesions occur, the bowel can easily be dissected free from the prosthesis.11 A potential drawback of

REPORT

Figure 7. Preoperative CT scan of obese patient with parastomal hernia.

GORE® DUALMESH® Biomaterial is risk for infection.13 In the only prospective series reporting on the laparoscopic repair of 55 parastomal hernias with an ePTFE patch, prosthetic infection was found in 3.6%.35 Once the mesh is infected, it should be removed. In general, infection of the mesh is not a major issue in a laparoscopic ventral or parastomal hernia surgery because it is considered to be a clean operation. Although when a bowel injury with fecal spill occurs, we recommend postponing mesh implantation for at least 6 weeks.

Conclusion When performing a parastomal hernia repair, surgeons can use a mesh with or without a slit. The former technique also is called the “keyhole technique.” Unfortunately, this technique has a high recurrence rate caused by progressive widening of the central keyhole. Recurrence rates of more than 30% have been reported.28,36 In 1985, Sugarbaker described the non-slit technique by which a mesh is used to cover the hernia opening with an overlap of 4 cm on each side, after the stoma loop is lateralized (Figure 8).37 A considerably lower recurrence rate of 11.6 % was reported.28 Recently, the use of biologic grafts in parastomal hernia repair has been published. Review of the literature, however, does not show better outcomes with the more expensive biologic materials.38

Figure 8. Postoperative CT scan with ePTFE patch.

Therefore, the Sugerbaker technique with GORE ® DUALMESH® Biomaterial is an effective technique.

Q&A Dr. LeBlanc: Do you ever use transfascial sutures for these procedures? If so, when do you decide to do so?

Dr. Hansson: Yes, I always use 2 nonresorbable sutures (Prolene 2.0) at the most lateral border of the mesh, at the left and right side of the “lateralized” bowel. Besides this, the mesh is fixed with titanium tacks (ProTack).

Dr. LeBlanc: Do you make an attempt to close the hernia defect in these cases?

Dr. Hansson: Nowadays, I don’t close the defect anymore.

I did in my study on the keyhole technique and after a while we noticed that the sutures disrupted. Since then, I prefer a tension-free repair. In the study, we operated on 55 consecutive patients with a symptomatic parastomal hernia using the keyhole technique (see also references). We closed the defect using a non-resorbable suture 0. We reoperated on 9 out of 55 patients because of a recurrent symptomatic hernia. During reoperation, we found that the sutures were disrupted and the mesh was everted due to the high intraabdominal pressure. We concluded that suturing the defect only has temporary result, after a while sutures disrupt. That’s why we believe that a tension-free repair is best.

Case 4 A 62-year-old woman with cirrhosis and massive hepatitis C virus–related (Child B) ascites undergoing intraperitoneal incisional hernia repair.

Antonio Iuppa, MD

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he patient underwent colon resection for a perforation resulting from diverticulitis 10 years ago. She developed a giant incisional hernia with skin ulceration and high risk for spontaneous evisceration (Figure 9). On admission to the hospital, the patient’s bilirubin and albumin levels were 2.5 mg/dL and 2.8 g/dL, respectively. The antithrombin III level was normal, and there was no previous history of bleeding.

Initial management included sterile occlusive dressing, fluid repletion, and antibiotic administration. The attempt to reduce ascites with medications failed. A peritoneovenous shunt was implanted 1 week before the repair with satisfactory results with a significant reduction of the ascites.

The initial plan was to perform a suprafascial extraperitoneal repair in order to avoid the opening of the peritoneum; however, the preservation of the peritoneum was impossible thus requiring an intraperitoneal approach. The procedure started

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REPORT

Figure 9. Preoperative CT scan showing the ascites and the hernia.

with the creation of a plane between the muscular fascia and the subcutaneous tissue so that the mattress stitches would not have to pass through the skin. The hernia sac was opened but not resected so that it could cover the mesh at the end of the operation. A posterior plane was created on the posterior face of the abdominal wall, detaching the adhesions, the falciform ligament, and the bladder. Once this posterior support area was created, the size of the defect was measured. It was determined that the prosthesis should be 4 to 5 cm larger than the defect, enabling gentle retraction of the margins without causing excessive tension. In this case, the GORE速 DUALMESH速 PLUS Biomaterial, measuring 26 x 36 cm, was used to avoid leakage of ascitic fluid.

The fixation of the mesh was performed with nonresorbable monofilament material. The suture was passed in U-shape from the abdominal wall to the mesh about 4 cm from the margin of the defect, covering the entire circumference of the defect.

After ensuring that the tension was uniform across the entire mesh, the residual hernial sac covered the mesh using interrupted reabsorbable stitches. This step separated the mesh from the subcutaneous tissue and supported the migration of fibroblasts into the mesh (Figure 10).

The patient had an uneventful recovery except for the appearance of a subcutaneous hematoma that did not require surgical intervention.

Conclusion One of the most challenging situations in patients with incisional hernias is the presence of cirrhosis and ascites. Abdominal wall repair in a patient with advanced cirrhosis presents an operative risk of great magnitude and may pose a considerable technical problem when complicated by the leakage of ascitic

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Figure 10. Postoperative CT scan showing the position of the mesh and the shunt.

fluid, necrosis of the abdominal wall with ulceration, rupture, strangulation, or infection.

Management of umbilical hernias in patients with cirrhosis and ascites remains difficult as these patients often have advanced liver disease and are at greater risk for complications following any surgical intervention. Elective surgical repair prevents complications, whereas morbidity after emergency surgery is up to 30%.39-41 Repair should be performed after optimal management of ascites, which includes fluid and salt restriction, diuretics, and possibly undergoing a transjugular intrahepatic portosystemic shunt procedure before surgery, if the ascites are difficult to control with medical therapy.

Q&A Dr. LeBlanc: What type of antibiotic coverage did you administer to this patient?

Dr. Iuppa: I administered vancomycin hydrochloride (2 g daily for 3 days), a nonabsorbable antibiotic that is effective against anaerobic gram-negative rods. It is useful in controlling portal systemic encephalopathy in patients with cirrhosis. It also has been shown that changes in blood ammonia concentrations correspond very well with changes in the number of anaerobic gram-negative rods in feces.

Dr. LeBlanc: Are the antimicrobial agents in the PLUS material essential in cases such as this one?

Dr. Iuppa: The GORE速 DUALMESH 速 PLUS Biomaterial is the only 2-sided, prosthetic material with antimicrobial agents (chlorhexidine and silver) that act synergistically to inhibit bacterial colonization and resist initial biofilm formation on the biomaterial for up to 14 days following implantation. This is of great importance when used in immunodepressed or debilitated patients such as those with cirrhosis.

REPORT

Case 5 A 48-year-old man undergoing continuous ambulatory peritoneal dialysis after ventral hernia repair.

Srdjan Rakic, MD, FACS

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he patient had undergone open sublay repair of a midline suprapubic incisional hernia using a polypropylene mesh (15 x 10 cm), and a laparoscopic repair of a large incisional hernia at midline incision using GORE® ® DUALMESH Biomaterial measuring 20 x 30 cm.42 Because the patient refused hemodialysis and kidney transplantation was not an option given the patient’s poor vascular status, continuous ambulatory peritoneal dialysis (CAPD) was indicated.42 Being aware of the potential risk for infection, it was essential to avoid compromising the GORE® DUALMESH® Biomaterial while inserting the CAPD catheter. A CT scan was used to determine the precise position of the mesh (Figure 11) and, consequently, to preoperatively draw a sketch of the mesh on the abdominal wall of the patient (Figure 12). With the mesh outlined, the CAPD catheter was implanted laparoscopically using 2 trocar ports that were positioned left laterally in the abdomen, while avoiding the GORE® DUALMESH® Biomaterial.42 Intraoperatively, the mesh was completely covered with intact neoperitoneum and omental adhesion.42 The procedure was carried out uneventfully. During the next 2 years, the patient experienced occasional episodes of CAPD-related peritonitis, requiring removal (3 times) or reinsertion (2 times) of the catheter.42 The latter procedures were performed using the same technique as the initial insertion of the CAPD catheter: left or right (Figure 13). In all instances, the mesh was left undisturbed and remained uninfected.

Conclusion This case highlights the importance of a radiopaque mesh for subsequent insertion of a catheter for CAPD. Abdominal surgery after laparoscopic ventral or incisional hernia repair (LVHR) can be challenging and requires careful planning and

Figure 11. Preoperative CT scan showing position of the mesh.

execution. A detailed preoperative assessment of the position and size of the previously implanted mesh is highly desirable. ePTFE mesh has the unique property of being revealed by CT scan due to its density and structure.

Reoperations in patients with a previous LVHR carry a risk for mesh contamination and infection. Therefore, it is imperative to avoid an incision through a mesh or coming into contact with it whenever possible, in order to minimize the risk for contamination. In this specific case, the ability to radiologically visualize the existing mesh provided the ability to safely insert a CAPD catheter 3 times and at 3 different sites, despite only having access to a relatively small portion of the abdominal wall during the procedure.

Q&A Dr. LeBlanc: Is it true that this is the only product that is truly “visible” on CT scans?

Dr. Rakic: Yes. Visibility of meshes or the property of being revealed by high-resolution imaging techniques such as CT or MRI is determined by 2 factors: predominantly by specific properties of mesh itself and, to a lesser degree, by a host inflammatory reaction generated by implanted prosthesis.

The most important properties of a mesh that determine its radiologic visibility are the density, structure, and thickness of the material used to produce a mesh. The only meshes that are always visible are GORE® DUALMESH® and GORE® DUALMESH® PLUS because of the high density of the material (ePTFE), its homogenous structure (nonwoven/not knitted), and its thickness (1, 1.5, or 2 mm). This feature allows for very precise and reliable measurements of mesh dimensions, position, and overlap.

Figure 12. Preoperative sketch of the mesh on the abdominal wall of the patient.

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REPORT The visibility of composite meshes containing ePTFE component (Composix, Ventralex, Intramesh T1, Dulex) is less consistent: Because the ePTFE component is much thinner (≤0.20 mm, they sometimes are clearly visible, whereas at other times they are not. As a general rule, these meshes easily can remain unrecognized when not specifically sought after and vice versa. Less reliable and less consistent visibility of these meshes do not allow for precise radiologic measurements compared with the first group.

All other meshes in general are not visible due to their isoattenuity relative to surrounding structures. Indirect evidence of mesh presence occasionally can be recognized, especially with MRI, due to the intense inflammatory response surrounding and incorporating the mesh (eg, scar tissue, meshoma).

However, precise and reliable measurements of mesh dimension, position, and overlap are impossible.

Dr. LeBlanc: In your mind, does the fact that this material did not become infected despite the episodes of peritonitis prove that there is no more susceptibility to infection with this material compared with other prosthetic materials?

Dr. Rakic: Possibly. I assume that every mesh placed into the abdominal cavity will be covered with some sort of neoperitoneum within a relatively short period. Complete neoperitonealization of mesh might well be crucial in protection against mesh infection. If this is really true, it is probably irrelevant as to which mesh is lying under neoperitoneum.

Figure 13. Plain x-ray of the abdomen showing the continuous ambulatory peritoneal dialysis catheter introduced on the right side of the abdomen. Tacks used for fixation of the mesh also are visible.

Case 6 Two patients undergoing giant abdominal wall desmoid resection and abdominal wall reconstruction.

Songzhang Ma, MD

A

31-year-old woman was diagnosed as having a giant desmoid tumor measuring 25 cm in diameter infiltrating the thickness of the abdominal wall (Figure 14). A complete tumor excision was performed and the abdominal wall was reconstructed using GORE® DUALMESH® Biomaterial measuring 20 x 30 cm (Figure 15).

A 25-year-old woman had undergone an abdominal wall desmoids resection 3 years prior to reoperation. Myocutaneous

Figure 14. A giant desmoid measuring 25 cm in diameter infiltrating the thickness of the abdominal wall.

10

flaps covered the defect. The tumor was recurrent in situ from the previous year and quickly developed a mass measuring 12 cm in diameter (Figure 16). The tumor was resected carefully and completely, and the abdominal wall was reconstructed using GORE® DUALMESH® Biomaterial measuring 18 x 24 cm (Figure 17).

GORE® DUALMESH® Biomaterial was secured to the deep fascial elements using interrupted 1-0 Prolene sutures, and subcutaneous closed suction drains were placed.

With both patients, the procedures were done successfully.

The postoperative period of both patients was uneventful and without any serious complications (eg, seroma or infection).

Figure 15. GORE® DUALMESH® Biomaterial was used to reconstruct the abdominal wall.

REPORT

Figure 17. GORE® DUALMESH® Biomaterial is used to reconstruct the abdominal wall with interrupted 1-0 Prolene sutures.

Figure 16. A recurrent desmoid tumor 3 years prior to reoperation.

Postoperative treatment included sulindac 200 mg twice daily and tamoxifen 20 mg daily. At the 24-month follow-up, there was no desmoid recurrence on the abdominal wall. Inspiration and expiration tests were used to measure the patients’ abdominal wall compliance, and the results showed that the abdominal wall was functioning well without any feeling of stiffness in both patients. At 6 months, however, a CT scan indicated a newly developed tumor on the mesentery in the 25-year-old patient.

Conclusion GORE® DUALMESH® Biomaterial was selected for abdominal wall reconstruction based on its following features considered ideal for the repair: • • • • •

Mesh pliability and compliance Tensile strength Biocompatibility Minimal adhesion with tissue and organs to the material Firm tissue attachment and ingrowth

Superficial desmoid tumors should be resected before they become large. The reconstruction of the abdominal wall with large soft tissue defects is usually very complicated and can be performed immediately using myocutaneous flaps or synthetic meshes. Because positive margins were associated with a 2-fold increased risk for local tumor recurrence, additional resection on surrounding tissue should be completed. Pathologic examination of the specimens of our patients confirmed

the presence of 2 to 3 cm margins of normal tissue around the tumor.

Q&A Dr. LeBlanc: How long were the drains left in place?

Dr. Ma: The time at which to pull the drainage tube is determined by the amount of drainage. If drainage is less than 20 mL per day, it can be considered. In case 1, the drainage tube was retained for 7 days. In case 2, it was retained for only 3 days. Because of the large surgical wound, tube retainment depends on the clinical signs. After pulling the tube out, an ultrasound or CT scan may be necessary. If any fluid remains in the abdominal cavity around the mesh, additional treatment may be required. In case 1, a CT scan showed a small amount of fluid but did not require further treatment.

Dr. LeBlanc: If you have to reoperate on patients such as these, what do you recommend for closure of the DUALMESH®?

Dr. Ma: This is a good question. In my opinion, if abdominal surgery is required, the conventional method to open and close the abdominal wall is acceptable. If the reoperation is for recurrence of tumor, removal of the tumor is performed first, and then repair the subsequent abdominal defect with a new mesh. It is easy to separate the adhesion between the GORE® DUALMESH® Biomaterial and the organ surface; the healed area with mesh in the abdominal wall can still be closed by using continuous sutures.

References 1.

Zografos GN, Mitropapas G, Vasiliadis F, et al. Open and laparoscopic approach in incisional hernia repair with ePTFE prosthesis.

J Laparoendosc Adv Surg Tech A. 2007;17(3):277-281.

6.

Matthews BD, Pratt BL, Pollinger HS, et al. Assessment of adhesion formation to intra-abdominal polypropylene mesh and polytetrafluoroethylene mesh. J Surg Res. 2003;114(2):126-132.

2.

W.L. GORE & Associates, Inc. GORE DUALMESH Biomaterial.

Flagstaff, AZ. 2010.

7.

3.

W.L. GORE & Associates, Inc. GORE-TEX soft tissue patch. http:// www.GOREmedical.com/stp. Accessed April 3, 2012.

Novitsky YW, Harrell AG, Cristiano JA, et al. Comparative evaluation of adhesion formation, strength of ingrowth, and textile properties of prosthetic meshes after long-term intra-abdominal implantation in a rabbit. J Surg Res. 2007;140(1):6-11.

4.

LeBlanc KA, Bellanger D, Rhynes KV 5th, Baker DG, Stout RW. Tissue attachment strength of prosthetic meshes used in ventral and incisional hernia repair. A study of the New Zealand White rabbit adhesion model. Surg Endosc. 2002;16(11):1542-1546.

8.

W.L. GORE & Associates, Inc. Proprietary ePTFE technology from GORE. http://www.GORE.com/en_xx/products/venting/packaging/eptfe_membrane.html. Accessed April 3, 2012.

9.

5.

Bauer JJ, Salky BA, Gelernt IM, Kreel I. Repair of large abdominal wall defects with expanded polytetrafluoroethylene (PTFE). Ann Surg.

1987;206(6):765-769.

“Material Matters” in Surgery. http:www.GOREmedical.com/newsletters/clsoing-remarks/issue-6/featured-topic.html. Accessed April 4, 2012.

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REPORT 10. Burger JWA, Luijendijk RW, Hop WCJ, Halm JA, Verdaasdonk GG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg.

2004;240(4):578-585.

11. Wassenaar EB, Schoenmaeckers EJP, Raymakers JFTJ, Rakic S. Subsequent abdominal surgery after laparoscopic ventral and incisional hernia repair. Hernia. 2010;14(2):137-142.

12. Koehler RH, Begos D, Berger D, et al. Adhesion formation to intraperitoneally-placed mesh: reoperative clinical experience after laparoscopic ventral incisional hernia repair. JSLS. 2003; 7(4):335-340.

13. Bleichrodt RP, Simmermacher RK, van der Lei B, et al. Expanded poly-tetrafluoroethylene patch versus polypropylene mesh for the repair of contaminated defects of the abdominal wall. Surg Gynecol Obstet. 1993;176(1):18-24.

14. Harrell AG, Novitsky YW, Kercher KW, et al. In vitro infectability of prosthetic mesh by methicillin-resistant Staphylococcus aureus.

Hernia. 2006;10(2):120-124.

15. A legacy of innovation in hernia repair: CORDUROY tissue ingrowth surface. GORE DUALMESH Plus. Flagstaff, AZ: W.L. GORE & Associates, Inc.; 2007.

16. Simmermacher RK, Schakenraad JM, Bleichrodt RP. Reherniation after repair of the abdominal wall with expanded polytetrafluoroethylene. J Am Coll Surg. 1994;178(6):613-616.

17. Cobb, WS, Kercher, KW, Matthews, et al. Laparoscopic ventral hernia repair: a single center experience. Hernia. 2006;10(3): 236-242.

18. LeBlanc KA. A new method to insert the DUALMESH prosthesis for laparoscopic ventral herniorrhaphy. JSLS. 2002;6:349-352.

19. Boyce B. Physical characteristics of expanded polytetrafluoroethylene grafts. (Stanley JC, ed). In: Biological and Synthetic Vascular Prostheses. New York: NY: Grune and Stratton; 1982:553-561.

20. Wassenaar EB, Schoenmaeckers EJ, Raymakers JT, Rakic S. Recurrences after laparoscopic repair of ventral and incisional hernia: lessons learned from 505 repairs. Surg Endosc. 2009;23(4):823-832.

after laparoscopic ventral incisional hernia repair with an expanded polytetrafluoroethylene mesh. Surg Endosc. 2009;23(7):1620-1623.

27. Carter PR, LeBlanc KA, Hausmann MG, Whitaker JM, Rhynes VK, Kleinpeter KP, Allain BW. Does expanded polytetrafluoroethylene mesh really shrink after laparoscopic ventral hernia repair? Hernia.

2012;16(3):321-325.

28. Hansson BM, Slater NJ, van der Veldon, et al. Surgical techniques for parastomal hernia repair: a systemic review of the literature.

Ann Surg. 2012;255(4):685-695.

29. Carlson MA, Frantzides CT, Shostrom VK, Laguna LE. Minimally invasive ventral herniorrhaphy: an analysis of 6,266 published cases. Hernia. 2008;12(1):9-22.

30. Matthews BD, Mostafa G, Carbonell AM, et al. Evaluation of adhesion formation and host tissue response to intra-abdominal polytetrafluoroethylene mesh and composite prosthetic mesh.

J Surg Res. 2005;123(2):227-234.

31. Jenkins ED, Yom V, Melman L, et al. Prospective evaluating of adhesion characteristics to intraperitoneal mesh and adhesiolysisrelated complications during laparoscopic re-exploration after prior ventral hernia repair. Surg Endosc. 2010;24(12);3002-3007.

32. Foda M, Carlson MA. Enterocutaneous fistula associated with ePTFE mesh: case report and review of the literature. Hernia.

2009;13(3):323-326.

33. Carne PW, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg. 2003;90(7):784-793.

34. Allen Mersh TG, Thomson JP. Surgical treatment of colostomy complications. Br J Surg. 1988;75(5):416-418.

35. Hansson BM, de Hingh IH, Bleichrodt RP. Laparoscopic hernia repair is safe and feasible: early results of a prospective clinical study including 55 consecutive patients. Surg Endosc. 2007;21(6):989-993.

36. Hansson BM, Bleichrodt RP, de Hingh IH. Laparoscopic parastomal hernia repair using a keyhole technique results in a high recurrence rate. Surg Endosc. 2009;23(7):1456-1459.

37. Sugarbaker PH. Peritoneal approach to prosthetic mesh repair of parastomy hernias. Ann Surg. 1985;201(3):344-346.

21. Luijendijk RW, Hop WC, van den Tol MP, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med. 2000;343:392-398.

38. Slater NJ, Hansson BM, Buyne OR, Hendriks T, Bleichrodt RP. Repair of parastomal hernias with biological grafts: a systematic review. J Gastrointest Surg. 2011;15(7):1252-1258.

22. Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years’ experience with 850 consecutive hernias. Ann Surg. 2003;238(3):391-399; discussion 399-400.

39. Carbonell AM, Wolfe LG, DeMaria EJ. Poor outcomes in cirrhosis-associated hernia repair: nationwide cohort study of 32,033 patients. Hernia. 2005;9(4):353-357.

23. Engemann JJ, Carmeli Y, Cosgrove SE, et al. Adverse clinical and economic outcomes attributable to methicillin resistance among patients with Staphylococcus aureus surgical site infection.

Clin Infect Dis. 2003;36(5):592-598.

40. Choi SB, Hong KD, Lee JS, et al. Management of umbilical hernia complicated with liver cirrhosis: an advocate of early and elective herniorrhaphy. Dig Liver Dis. 2011;43(12):991-995.

24. Rios A, Rodriguez JM, Munitz V, Alcaraz P, Pérez Flores D, Parilla P. Antibiotic prophylaxis in incisional hernia repair using a prosthesis.

Hernia. 2001;5(3):148-152.

25. W.L. GORE & Associates, Inc. GORE DUALMESH Plus Biomaterial.

Flagstaff, AZ. 2010.

26. Schoenmaeckers E, van der Valk S, van den Hout H, Raymakers JF, Rakic S. Computed tomographic measurements of mesh shrinkage

41. Ahmad TAA, Ali SM, Zaghloul N, El-Minshawy O. Complicated umbilical hernia in cirrhotic patients with ascites. Egyptian J Surg.

2004;23(2):167-171.

42. Schoenmaeckers E, Woittiez AJ, Raymakers J, Rakic S. Continuous ambulatory peritoneal dialysis after intra-abdominally placed synthetic mesh for ventral hernia repair. J Laparoendosc Adv Surg Tech A. 2011;21(8):741-743.

Financial Disclosures:

This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, GORE, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature.

Copyright © 2012, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

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SR123

Disclaimer: Gore products referenced within, if any, are used within their FDA approved/cleared indications. Gore does not have knowledge of the indications and FDA approval/clearance status of non-Gore products. Gore makes no representations as to the surgical techniques, medical conditions or other factors that may be described in this article. The reader is advised to contact the manufacturer for current and accurate information. AQ0106-EN1

RP1564

Dr. LeBlanc reported that he is a consultant and on the speakers’ bureau for W.L. GORE, CR Bard, and Covidien. He also is on the medical advisory board for Via Surgical. Dr. Carbonell reported that he is a consultant and on the speakers’ bureau for W.L. GORE and a consultant for Ethicon Endo-Surgery and Bard Davol. Dr. Doerhoff reported that he is on the speakers’ bureau for W.L. GORE, Ethicon Endo-Surgery, and Covidien. Drs. Hansson, Iuppa, Rakic, and Ma reported no relevant financial conflicts of interest.

September 2012 Brought to You by

REPORT Technological Advancements in Tissue-Sealing Devices Introduction Laparoscopic surgery began to gain ground in the operating rooms (ORs) of the 1990s. Since then, this minimally invasive approach has amassed substantial evidence to support its equivalence and/or superiority to open techniques in terms of blood loss, pain, hospital length of stay, return to normal activities, cosmesis, and a host of other factors.1-3 Laparoscopy is now considered the standard of care for the majority of procedures for

which it is indicated. Although researchers continue to explore its utility, few would dispute its overall advantages for patients.

Laparoscopic surgery still presents challenges to the surgeon in terms of access, visualization, and tactile feedback, as well as ergonomic compromises that result in an occupational injury rate similar to that of symphony musicians.4,5 Hemostasis, one of the basic components of surgery, is particularly demanding during

Faculty David Arrese, MD

Benyamine Mizrahi, MD

Sonia Ramamoorthy, MD

Surgical Oncologist Riverside Methodist Hospital Columbus, Ohio

Colorectal Surgeon Colorectal Surgical Associates, PC Kansas City, Missouri

Matthew Kalady, MD

Sharon L. Stein, MD

Assistant Professor of Surgery Cleveland Clinic Cleveland, Ohio

Director, Acute Intestinal Failure Clinic Case Western Reserve University Medical Center Cleveland, Ohio

Associate Professor of Surgery Chief, Section of Colon and Rectal Surgery Rebecca and John Moores Cancer Center University of California, San Diego Health System La Jolla, California

James Dana Kondrup, MD Minimally Invasive Surgeon Lourdes Hospital Binghamton, New York Surgeonsâ&#x20AC;&#x2122; views are based on individual experiences and are not to be construed as claims made by EES.

Supported by

REPORT

laparoscopic procedures due to the limitations of vesselsealing methods that solely rely on compression, such as sutures, clips, and staples. Thus, as technology has evolved to propel the adoption of laparoscopy, surgeons have come to depend on energy-based vessel-sealing devices that offer reliable seals within the confines of a laparoscopic port.

But not all energy-based devices are created equal. In bipolar energy devices, the current only passes through tissue that is located between the instrument’s electrodes.

This offers potential advantages over monopolar devices regarding safety and precision related to the unintended dispersal of current.6 Even bipolar energy devices do not perform the same, as they can vary in measures such as burst pressure and thermal damage to vessels.7 The ENSEAL® System, marketed by Ethicon Endo-Surgery, Inc., was developed to meet and exceed the demands of vessel sealing while also offering the ability to perform other functions. Specifically, ENSEAL® Devices provide reliable hemostasis, are designed to minimize thermal spread, and can be used to grasp and dissect tissue,8 which can offer flexibility and efficiency to surgeons. In 2003, the FDA cleared the bipolar ENSEAL® Device to seal vessels up to 7 mm in diameter.9 Since then, ENSEAL® Technology has been modified and refined, largely based on surgeon feedback. Today, ENSEAL® Devices are indicated for an array of procedures, including general, colorectal, gynecologic, bariatric, thoracic, and urologic surgeries.9 The latest additions to the ENSEAL® Portfolio include the G2 Curved and Straight Tissue Sealers for laparoscopic surgery and the G2 Super Jaw Tissue Sealer for open procedures, which expand the ENSEAL® Line with superior sealing and a superior sealing experience.

liked the fact that he could tell where the cutting blade was at all times. “The ENSEAL® I-BLADE™ has a gold square that tells you exactly where it is during the surgical procedure,” he added (Figure 1).

“Finally, another feature I like is the learning curve. As I travel all over the world, I have to teach residents and new surgeons how to use ENSEAL® on demand. I find the learning curve to be very manageable,” said Dr. Kondrup.

Sonia Ramamoorthy, MD, associate professor of surgery, chief, Section of Colon and Rectal Surgery, Rebecca and John Moores Cancer Center, University of California, San Diego Health System in La Jolla, performs approximately 80% of her cases laparoscopically. The majority of these cases are cancer- and inflammatory bowel disease–related procedures. Dr. Ramamoorthy described herself as a former diehard user of LigaSure™ devices. However, she noticed that many of her colleagues—including those recognized as pioneers and innovators of minimally invasive surgery and laparoscopy—were using ENSEAL® Devices in videos of laparoscopic procedures presented at surgical meetings.

“I wondered what the difference was,” she said. “So I thought I’d give it a try and see how I liked it.”

It took Dr. Ramamoorthy a few cases to get used to the ENSEAL® System, especially when training residents. “But once I started, I really found it to be very reliable in terms of getting at mesenteric vessels,” she said. “I think LigaSure™ and ENSEAL® are both good devices, but the reliability of one over the other is what really matters to me. When I am

Considerations for the ENSEAL® System James Dana Kondrup, MD, a minimally invasive surgeon at Lourdes Hospital in Binghamton, New York, has been practicing minimally invasive surgery for 24 years. He began using the ENSEAL® System 3 years ago to bolster his armamentarium (rather than to replace his existing devices).

“In the early years, I was using the tri-polar electric cautery, then I started using the HARMONIC ®,” he said. “I travel around the world and teach internationally, and I always come across surgeons using different energy sources. I knew it was important for all surgeons to be familiar with at least 2 energy sources, so when ENSEAL® came out, it was an excellent opportunity to add it to my regimen of surgical tools.”

There were several features that Dr. Kondrup liked in particular about the ENSEAL® System. “The first was that the energy inside the device had minimal thermal spread, only a few millimeters from the instrument,” he said. Dr. Kondrup also

2

Figure 1. Additional compression is achieved by advancing the I-BLADE™ during coagulation.

Image courtesy of James Dana Kondrup, MD.

REPORT

going through difficult or inflamed mesenteries, or [performing surgery on] obese patients, I find ENSEAL® does a good job of sealing the tissue.”

This reliability also may have been the factor that influenced her peers. “I asked quite a few of them why they use ENSEAL®, and they said they just thought it was reliable in sealing the vessels. They felt confident about the hemostasis, and I would agree with that,” said Dr. Ramamoorthy.

ENSEAL® Vessel-Sealing Technology Advancing Superior Sealing ENSEAL® Devices use a patented temperature-controlled, bipolar energy delivery system in the jaw and a unique cutting mechanism, the I-BLADE™, to produce minimal thermal spread and strong, uniform compression across the entire length of the seal.8 Teeth located along the jaw of each instrument serve to facilitate the handling and grasping of tissue. Surgeons also can combine different shaft lengths and jaw configurations (ie, straight or curved) to accommodate a variety of procedures.10 Together, these features allow for the safe and thorough transection of large tissue bundles, multifunctionality, and superior sealing.

Excessive thermal spread from bipolar instruments is a major concern for laparoscopic surgeons.11 The nature of laparoscopy limits surgeons’ ability to assess the degree to which potentially traumatizing heat is being transferred beyond its intended target. Surgeons usually cannot feel it themselves, so they need to be able to understand the thermal spread and capabilities of their energy device.

“During an open procedure, if it’s getting too hot I can adjust appropriately to make sure any tissue is far enough away,” said David Arrese, MD, a surgical oncologist at Riverside Methodist Hospital in Columbus, Ohio. “But when I’m operating laparoscopically, I don’t have my hand in there. I’m concerned about thermal spread because I’m dissecting close to ureters, the small bowel, or the colon, and I’m really concerned about injuring these structures.”

ENSEAL® uses sophisticated technology to measure the temperature of the instrument and to modify the energy flow so that the temperature is high enough to seal vessels, but low enough to minimize lateral thermal spread. “The thermal spread is very minimal with ENSEAL®,” Dr. Arrese said. “It has carbon fibers within the jaw that deactivate when the tissue reaches 100 οC, so that limits the thermal spread.”

ENSEAL® Devices use positive temperature coefficient (PTC) technology to achieve closely regulated energy with a minimal degree of thermal spread. The PTC polymer located in the instrument’s top jaw contains chains of conductive particles that continuously modulate energy throughout

the activation cycle. As the temperature in the jaw reaches 100 οC, the polymer expands and the chains break apart.

The disconnection of the chains results in a discontinuation of conductivity, which prevents the flow of electric current, ultimately reducing the temperature. When temperatures fall below 100 οC, the conductive particle chains come back together, thus restoring the flow of electricity and bringing the temperature back up.12 This back-and-forth, hot–cold cycle continuously relays while the instrument is in use, and it is sensitive along the entire length of the jaw. This is important because tissues can be highly heterogeneous and can vary in density.

“The PTC in the ENSEAL® Jaw has sensing particles, so it does a good job in making sure the temperature is uniform throughout rather than having a portion where, for example, if it’s just spreading from a middle line toward the sides, the temperature might not be as uniform and you might not get the same kind of seal in all places,” said Sharon L. Stein, MD, director, Acute Intestinal Failure Clinic, Case Western Reserve University Medical Center in Cleveland, Ohio.

Dr. Ramamoorthy appreciates being able to rely on the designed minimal thermal spread of the ENSEAL®. “The lateral spread is minimal in either direction, and I think that is very important, especially as you’re doing work around neurovascular bundles,” she said. “You want to make sure you are treating only the vessel you want to treat and not, perhaps, the nerves that are sitting around it. Otherwise, you could injure or damage someone’s nerve supply for bladder or sexual function, as we see in colorectal surgery.”

Dr. Kondrup feels confident in how ENSEAL® functions.

“ENSEAL® only goes up to 100 οC. It will not go above that, and other instruments will go well above that,” he said. “Tissue damage can result from direct cautery from the electricity and from heat damage, when the temperature goes so high it actually damages the tissue laterally. So I feel it’s important to keep heat down so that you don’t cause any additional damage to the tissue.”

Advantages of the I-BLADE™ For Dr. Stein, the most important feature of any vesselsealing device is its ability to provide sound, reliable hemostasis. “The most important thing is the security of the vessel transection. I don’t typically use staplers to transect vessels; for the inferior mesenteric artery or ileocolic artery, I typically use an advanced-energy device,” she said. “Having the security that the device is going to seal and seal well every time is imperative—a no brainer. If you start to have leaks or bleeding afterward, that is completely unacceptable.”

ENSEAL® uses tissue compression along with heat to seal vessels, and its cutting mechanism, the I-BLADE™,

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■ ENSEAL® G2 Curved

250

Average Compression, psi

■ LigaSure™ 5 mm Blunt Tip

200

150

100

50

0

Proximal third

Medial third

Distal third

Jaw Position

Figure 2. Compression analysis of 2 laparoscopic energy-delivery devices.a a

In side-by-side benchtop testing, average compression at distal 0.11 in of jaw: 187 psi (SD=81 psi) for ENSEAL® TRIO vs 40 psi (SD=9 psi) for LigaSure™.

From reference 13.

thoroughly and cleanly transects tissue. It offers strong, uniform compression along the entire length of the jaw,7 and it delivers appropriate doses of energy to each tissue thickness within it. The cutting blade is located within the instrument’s teeth, which enables the blade to stay in place. “Being [located] within the teeth, it’s sort of like the I-BLADE™ is between railroad tracks. The knife cannot jump out of the teeth of the instrument,” said Dr. Arrese.

“With a lot of other devices now, the cutting already happens or you just push a button and it’s an automated process. But the ENSEAL® gives you a little more visual and physical control over how quickly your tissue is cut,” explained Dr. Ramamoorthy. “The way the ENSEAL® works is that you first grasp the tissue and then apply the compression. As you apply compression, you activate energy; you advance the I-BLADE™ forward and energy delivery moves with the blade because you’re compressing. The I-BLADE™ is nice because you can see how fast or slow you are cutting the tissue; that’s under your control.”

Although competing energy devices may lose compression as the surgeon moves distally,a ENSEAL® is designed to provide durable, consistent, and reliable compression throughout the entire length of the instrument (Figure 2).13 Matthew Kalady, MD, assistant professor of surgery at the

a

4

Cleveland Clinic in Ohio, noted that during both his surgical residency and fellowship, he and most of his peers used LigaSure™ devices. “But I tried ENSEAL® because its technology is a little bit different,” he said. “[ENSEAL® ] has the I-BLADE™ Technology, and I think there is a bit more uniform distribution of the energy and compression on the vessels. I think it gives a good seal, and [the compression] goes all the way out to the end of the vessel as well.”

ENSEAL® Devices can seal tissue of all sizes, up to and including vessels that are 7 mm in diameter.8 “It’s a very consistent instrument when it comes to hemostasis,” said Dr. Kondrup. “That’s one of the advantages of ENSEAL®, the reliable hemostasis when I’m doing more difficult cases.

It’s very user friendly as far as controlling blood vessels.” In a benchtop comparison of seal strengths across 52 device activations, porcine arteries sealed with ENSEAL® displayed superior burst strengths versus those sealed with LigaSure™ (P<0.05; Figure 3).13 Dr. Ramamoorthy also is confident that the ENSEAL® will reliably perform the tasks for which it is indicated. “I think any device I use has to be able to seal a large amount of tissue. Being able to reliably seal 5- and 7-mm vessels is important,” she said. The ability of the ENSEAL® to seal large vessels may reduce reliance on other instruments,

In side-by-side benchtop testing, average jaw compression was 201 psi (SD=42 psi) for ENSEAL® TRIO versus 96 psi (SD=9 psi) for LigaSure™.

Data on file. Ethicon Endo-Surgery, Inc.

Vessel Burst Pressure, mm Hg

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1,600 1,500 1,400 1,300 1,200 1,100 1,000 900 800 700 600

ENSEAL® G2 Curved

2

9

16

ENSEAL® G2 Straight

23

30

37

LigaSure™ 5 mm

44

51

Figure 3. Strength of tissue seals across multiple device activations.a a

Benchtop study using 5-mm porcine carotid arteries. Burst pressure was measured over 52 activation cycles (P<0.05).

From reference 13.

and may improve efficiency in the OR by reducing the number of instruments needed.

Versatility and Customization The ENSEAL® System is designed not only to provide consistent, reliable hemostasis in vessel sealing, but also can serve as a tissue grasper and dissector. “These days we’re trying to find instruments that are multifunctional, that don’t just deliver energy, but that also can help us to do a little dissection or pick things up, and I think ENSEAL® allows us to do things like that,” Dr. Ramamoorthy said. “It’s a nice device for us to use in terms of not having to switch multiple devices in and out of the patient’s abdomen. I can dissect with it, I can seal vessels with it, and then I can keep going with my dissection. I don’t have to switch out to a grasping device. It works pretty well for several different applications in the abdomen.”

Dr. Ramamoorthy suspects that being able to use an energy device that fits through a 5-mm port, unlike a large stapler that would require a 12-mm port, allows surgeons to reduce the size of the incision needed to achieve reliable vessel sealing. “This really facilitates laparoscopic cases,” she added.

Dr. Kondrup finds that the multifunctionality of ENSEAL® Devices improves his operating efficiency (Figure 4). “There are some instruments on the market that just cauterize, but don’t cut,” he said. “With ENSEAL® you have the ability

to activate the cautery and then quickly cut; when you’re moving along and cutting adhesions, it’s very rapid. You don’t have to take the instrument out and get a hemostatic device, because it is a hemostatic device.”

A study by Person and colleagues investigated several parameters of vessel sealing in porcine vessels and compared

Figure 4. An ENSEAL® Device coagulating and cutting the mesoappendix during an appendectomy.

Image courtesy of James Dana Kondrup, MD.

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Figure 5. The ENSEAL® G2 Advanced Bipolar Tissue Sealer.

ENSEAL® with the LigaSure™ V and LigaSure Atlas™.7 They found that ENSEAL® offered faster seal times, comparable seal quality, and higher burst pressure versus LigaSure™.

ENSEAL® also created less radial thermal damage to the adventitial collagen than LigaSure™.7 Several risk factors are associated with time on the operating table and shorter times on the operating table offer better patient outcomes.14 “So it’s nice to be able to save some time, save the patient money, save the hospital money, and reduce risk by getting patients off the table,” said Dr. Kondrup.

ENSEAL® also offers surgeons a greater degree of ergonomic flexibility. It can be used by right- or left-handed surgeons and is available in shaft lengths of 14, 25, 35, and 45 cm.10 Surgeons can choose a straight or curved tip, the latter of which Dr. Ramamoorthy prefers. “I think having a curved tip allows me to get around certain vessels at the proper angle, so I like having that option,” she noted.

“We’re able to do a lot of different things with ENSEAL®.

It used to be very difficult to take a fatty mesentery with an energy device, and I don’t think that’s the case any more—we don’t have to convert to do the mesentery extracorporeally,” said Dr. Ramamoorthy. “In some ways, I think ENSEAL® has really facilitated what we can do laparoscopically or robotically, allowing us to complete more of the operation with a minimally invasive approach.”

The ENSEAL® G2 Platform In September 2011, Ethicon Endo-Surgery invited an experienced group of surgeons to try out the latest generation

6

of ENSEAL® Technology: The ENSEAL® G2 Platform (Figure 5) and the ENSEAL® G2 Super Jaw Tissue Sealer. Both of these devices, along with HARMONIC® Devices, are compatible with the Ethicon Endo-Surgery Generator G11. The surgeons who attended this workshop included both dedicated ENSEAL® users and those who use competing devices.

Dr. Stein felt that the ENSEAL® G2 Platform is a major improvement over other devices because of its intuitive nature. “Before, I felt like I was about to cut when I wanted to be burning, and vice versa,” she said. “For most of us, we cut when we’re pulling something. But [before], that was the burning device and to me, that was very counterintuitive and backward.”

As a user of a competing device, Dr. Stein found the new ENSEAL® G2 Device did not challenge her muscle memory or make her ponder her every move. “Every time you do a case, you can’t be thinking, for example, ‘I have to burn, then I have to cut—clamp, burn, cut, open.’ [Instead,] you want it to be fluid and easy,” she said.

Dr. Arrese was particularly pleased with the ENSEAL® G2 Super Jaw, which is indicated for use in open procedures.

“This is where I really see the big difference between ENSEAL® and LigaSure™. Also, the blade will never come out of the curve of the teeth,” he said.

Most modifications to the new ENSEAL® G2 Platform were meant to provide a superior sealing experience 8 through enhanced ergonomics, tactile feedback, and safety, while retaining the positive characteristics of the older ENSEAL® Portfolio. Dr. Kondrup was among the first to test the ENSEAL® G2 Platform when it was first approved for human

REPORT

cases. “The first thing I noticed about it was the handle,” he said. “It was extremely comfortable compared with the original ENSEAL® Device, similar to the HARMONIC® ; very user friendly and very easy to advance the blade. The reduction in finger fatigue is just amazing.”

The second thing that Dr. Kondrup noticed were the changes to the instrument’s jaw. “The positive electrode is now welded to the lower jaw, so there is 1 piece, as opposed to 2 separate pieces. I believe it’s sturdier,” he said.

Some features, however, are hard to improve on. “The hemostasis is just as reliable as the original. [But] it’s hard to imagine an improvement in hemostasis when you’ve had good hemostasis to start with,” noted Dr. Kondrup.

“They made a few changes from the prior instruments.

In one prior edition, you could cut through the tissue without sealing it first—the previous edition did not have a mechanical stop to prevent you from cutting the tissue without sealing it first,” said Dr. Kalady. “I work with fellows every day, and if they’re not familiar with how to handle the instrument they could actually cut through a vessel or through tissue before it’s sealed. There were safety controls on the handle of that instrument, but I found it cumbersome to go between the safety mode and the [working mode].”

Dr. Kalady also found the noise produced by the previous ENSEAL® Generator to be bothersome. “When the machine was activated, it made a very annoying tone,” he said. “They changed that to make a much more pleasing background noise [with the Ethicon Endo-Surgery Generator G11]. Now there is one tone when it is activated to work, another tone when you’re at the point where you start to cut, and a final, single tone that goes off to indicate that you’re safely through everything.”

Benyamine Mizrahi, MD, a colorectal surgeon at Colorectal Surgery Associates, PC, in Kansas City, Missouri, has used LigaSure™ devices since his surgical residency. This continued through his 2 fellowships and his past 2 years as a practicing surgeon. But he is open to the possibility of using another instrument. “I think there is room to make things better in an energy device. I’m not committed to one product over another, I just want the best tool to make surgery go smoother and faster,” he said. “If ENSEAL® has what it takes, then I’d love to use it.”

All vessel-sealing devices have their pros and cons, explained Dr. Mizrahi. “One thing ENSEAL® does better is the compression it provides, because of the I-BLADE™ Technology.a You have a better, tighter seal and closure from the beginning of the blade to the end,” he said.

ENSEAL® G2 Devices (G2 Straight, G2 Curved, and G2 Super Jaw) offer more than twice the compression at

the distal tip of the jaws than the LigaSure™,8,b and this characteristic can pay off in many ways. “The better the seal, the less bleeding you get and the less often you need to coagulate, so that makes the procedure go faster,” said Dr. Mizrahi. “That means less time in the OR, less time the patient is under anesthesia, and the more cases you can do—everyone is happy.”

In addition to its superior compression, Dr. Mizrahi believes that the ability to see exactly where he is burning and cutting gives ENSEAL® an edge over LigaSure™. “With the Ligasure™, you close, you burn, it lets you know when it’s done, and then you cut. You don’t see the blade. With ENSEAL®, you’re sealing and you can see right where you’re sealing, and you can bring the blade up to that point.

Essentially, you control what you’re cutting,” he said.

Although LigaSure™ is the device with which he is the most familiar and comfortable, Dr. Mizrahi sees room for ENSEAL® in his OR. “ENSEAL® definitely has promise. If I’m able to do the case more efficiently and with less fatigue and can get the same job done, then I’m definitely going to be using it,” he said.

Dr. Kondrup estimated that surgeons who are unfamiliar with ENSEAL® would be able to quickly adjust to it. “I find the learning curve to be very manageable and I think that most surgeons will be able to adapt from other energy devices,” he said. “There are no adjustments to be made, no numbers to turn on and off. You simply plug it into the generator, the generator tests the instrument, and you’re ready to go.”

He does recommend that surgeons exercise caution with any new instrument before trying it out on a case. “I think it’s important to use the instrument in a benchtop demonstration first—don’t take it right into the OR,” said Dr. Kondrup. “The only real concern I have is that surgeons get to know how the instrument operates.”

Dr. Stein always takes a cautious approach when she uses a new instrument on a case for the first time. “I’ll start off on something that is not imperative, like a little piece of omentum, to make sure I’m comfortable with what I’m doing,” she said. “With the G2 [Device], once I’d used it a handful of times, I saw that what I needed to do was very intuitive and I could just go on with my case.”

Conclusion ENSEAL® Devices deliver strong seals while providing a superior sealing experience. Their multifunctionality and customization provide surgeons with a high level of flexibility with minimal thermal spread. The availability of the ENSEAL® G2 Portfolio gives surgeons another option for performing a variety of surgical procedures.

a

Average jaw compression: 110 psi ENSEAL® G2 Super Jaw versus 91 psi LigaSure Impact™ and 80 psi LigaSure Atlas™, P<0.0000.

Test conducted on an inanimate model. Data on file. Ethicon Endo-Surgery, Inc.

b

In side-by-side benchtop testing, average jaw compression was 201 psi (SD=42 psi) for TRIO versus 91 psi (SD=13 psi) for Impact™.

Data on file. Ethicon Endo-Surgery, Inc.

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REPORT

1. Reza MM, Blasco JA, Andradas E, Cantero R, Mayol J. Systematic review of laparoscopic versus open surgery for colorectal cancer. Br J Surg. 2006;93(8):921-928.

2. De U. Laparoscopic versus open appendicectomy: An Indian perspective. J Minim Access Surg. 2005;1(1):15-20.

3. Jin C, Hu Y, Chen XC. Laparoscopic versus open myomectomy—a meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2009;145(1):14-21.

4. Raymond DM, Romeo JH, Kumke KV. A pilot study of occupational injury and illness experienced by classical musicians. Workplace Health Saf. 2012;60(1):19-24.

5. Park A, Lee G, Seagull FJ, Meenaghan N, Dexter D. Patients benefit while surgeons suffer: an impending epidemic. J Am Coll Surg. 2010;210(3):306-313.

8. Ethicon Endo-Surgery. ENSEAL® G2 Tissue Sealer (Curved/ Straight) Product Fact Sheet. http://www.ees.com/node/43144.

Accessed July 30, 2012.

9. ENSEAL® 510(k) submission. www.accessdata.fda.gov/cdrh_ docs/pdf4/KO43008.pdf. Accessed July 30, 2012.

10. Ethicon Endo-Surgery. ENSEAL® G2 Curved and Straight Tissue Sealers–Description and Specs. http://www.ees.com/Clinician/ Product/energy/enseal-g2-tissue-sealers#!Description%20&%20 Specs. Accessed July 29, 2012.

11. Newcomb WL, Hope WW, Schmelzer TM, et al. Comparison of blood vessel sealing among new electrosurgical and ultrasonic devices. Surg Endosc. 2009;23(1):90-96.

12. Ethicon Endo-Surgery. Energy Devices Portfolio. http://www. ees.com/sites/default/files/generalsurgery_EES_Energy_ Devices_Portfolio.pdf. Accessed July 30, 2012.

13. Data on file. Ethicon Endo-Surgery, Inc. 14. Jackson TD, Wannares JJ, Lancaster RT, Rattner DW, Hutter MM. Does speed matter? The impact of operative time on outcome in laparoscopic surgery. Surg Endosc.

2011;25(7):2288-2295.

Financial Disclosures: Drs. Arrese and Kalady reported that they have received honoraria from Ethicon Endo-Surgery. Dr. Kondrup reported that he has served as a consultant and member of the speakers’ bureaus for Ethicon Endo-Surgery, Ethicon Women’s Health & Urology, and PALL Medical.

Dr. Mizrahi reported that he has received honoraria from Ethicon Endo-Surgery. Dr. Ramamoorthy reported that she has served as a consultant for and has received honoraria from Ethicon Endo-Surgery. She also has served as a consultant for Covidien. Dr. Stein reported that she has received honoraria from Covidien and Ethicon Endo-Surgery.

Disclaimer: This monograph is designed to be a summary of information. Although it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Ethicon Endo-Surgery, and the authors neither affirm nor deny the accuracy of the information contained herein. Ethicon Endo-Surgery has participated in the editorial process. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature.

Copyright © 2012, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

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OSS# ECP615

References

7. Person B, Vivas DA, Ruiz D, Talcott M, Coad JE, Wexner SD. Comparison of four energy-based vascular sealing and cutting instruments: a porcine model. Surg Endosc. 2008; 22(2):534-538.

DSL# 12-0653

For complete product information, please refer to the instructions for use in the package insert.

6. Massarweh NN, Cosgriff N, Slakey DP. Electrosurgery: history, principles, and current and future uses. J Am Coll Surg. 2006; 202(3):520-530.

SR1123/SR1228

“The new ENSEAL® G2 Platform is an amazing improvement in the design of the handle, and the addition of the Ethicon Endo-Surgery Generator G11, which provides feedback as you use the instrument, is extremely helpful, especially for new surgeons,” said Dr. Kondrup. “I don’t think anything else on the market comes close to allowing you to see where the blade is, cut and cauterize, and dissect. I’m extremely happy with that instrument, and I’m also happy to be able to choose either the ENSEAL® or HARMONIC® Technology, as indicated for a particular case.”