February 28 - March 3, 2017 Encore at Wynn Las Vegas

Improving Patient Outcomes with Minimally Invasive Surgery

Each month, MISS eNews brings you the latest on novel minimally invasive techniques and findings from around the world.

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Vol. 8 No. 11
Welcome to the March issue of MISS E-News! I hope you find this month’s interview with Dr. Stephanie B. Jones valuable; she shares with us some critical aspects of enhanced recovery after surgery from an anesthesiologist’s perspective. Attendees of this month’s MISS Meeting were fortunate to hear Dr. Jones share her expertise on fluids and pain management during the MISS Enhanced Recovery after Surgery Program. (Couldn’t make this year’s MISS meeting? Save the date for next year: March 6-9, 2018.)
We have some new contributors of selected readings this month, including Robert Lim and Jonathan Thompson, who have imparted their thoughts on critical current articles in minimally invasive surgery. I hope you enjoy this month’s edition and please feel free to contact us with any feedback!

— Colleen Hutchinson

Enhanced Recovery Interview
Could you please tell us about enhanced recovery and its development?
Dr. Jones: The concept of enhanced recovery after surgery was first promoted in the late 1990s by Danish surgeon Henrik Kehlet in his work on fast-track colorectal surgery. Enhanced recovery uses protocol-driven, multimodal pathways with the aim of reducing the surgical stress response and speeding recovery. Many of the components of the enhanced recovery pathways were revolutionary at the time–eliminating nasogastric tubes and postoperative drains, for example–but as the positive evidence has accumulated over the years, these practices have become more widely accepted. Enhanced recovery starts as early as preadmission with patient education and optimization, and contains specific elements for pre-, intra-, and postoperative care.

What kind of anesthesia is the most favorable to enhance the enhanced recovery protocol?
Dr. Jones: The type of maintenance anesthetic (intravenous versus inhalational) is less important than achieving the overall goals of enhanced recovery. For the anesthesiologist, these include use of non-opioid or opioid-sparing multimodal pain strategies, postoperative nausea and vomiting (PONV) prophylaxis, and "zero balance" fluid management, avoiding both hyper- and hypovolemia. Some do advocate use of propofol-based total intravenous anesthesia in patients at high risk for PONV as inhalational anesthetics can contribute to PONV. For most patients, use of multiple prophylactic antiemetics will suffice. Dexamethasone and ondansetron are common choices. Reducing or avoiding opioids altogether will also help reduce the incidence of PONV.

Does preemptive analgesia help with enhanced recovery protocols?
Dr. Jones: I hesitate to use the term preemptive analgesia as the evidence for this in humans has never really materialized. However, the administration of non-opioid adjuncts preoperatively, in order to achieve therapeutic levels of drug intraoperatively, is a key component of enhanced recovery. Oral acetaminophen is widely used, and gabapentinoids (gabapentin and pregabalin) are becoming increasingly popular as part of opioid-sparing strategies that then are extended into the postoperative period.

Should epidural analgesia be part of enhanced recovery?
Dr. Jones: Thoracic epidural analgesia (TEA) has shown benefit in patients undergoing open abdominal surgery. TEA provides improved pain relief, reduces respiratory and cardiac morbidity, and speeds gastrointestinal (GI) recovery. But there are also risks, including hypotension, motor block, and urinary retention. For laparoscopic procedures, where postoperative pain is less intense, many have abandoned TEA in favor of less invasive procedures such as TAP blocks. However, TEA may still be advantageous for laparoscopic colorectal procedures, due to improved GI motility.


Suggested Readings:
Article: A nomogram to predict disease-free survival after surgical resection of GIST. Bischof D, Kim Y, Behman R, et al. J Gastrointestinal Surgery 2014;18(12):2123-2129.
Dr. Robert Lim: The risk of recurrence of a GIST malignancy remains undefined and surgery remains the mainstay of therapy for such tumors. There are several nomograms used to predict disease recurrence. The nomogram presented by the authors seems to be more inclusive and a better predictor of recurrence and thus the need for adjuvant therapy. This paper also highlights the need for routine KIT mutational analysis testing as it may identify more patients who would benefit from adjuvant imatinib therapy.

Article: Efficacy of transoral incisionless fundoplication (TIF) for the treatment of GERD: a systematic review with meta-analysis. Huang, Xiaoquan, Shiyao Chen, Hetong Zhao, Xiaoqing Zeng, Jingjing Lian, Yujen Tseng, and Jie Chen. Surgical Endoscopy (2016): 1-13.
Dr. Bill Richards: Meta-analysis of the transoral incision-less fundoplication (TIF) from 5 randomized controlled trials and 13 prospective observational studies were pooled to evaluate the results after TIF. The study shows the pooled results of the TIF 1.0 and TIF 2.0 are an alternative in carefully selected GERD patients, but that efficacy declines over time and satisfaction at 6 months is 69.15%.
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Article: Impact of the specific extraction-site location on the risk of incisional hernia after laparoscopic colorectal resection. Benlice C, Stocchi L, Costedio MM, Gorgun E, Kessler H. Dis Colon Rectum. 2016 Aug;59(8):743-50.
Dr. Sean Langenfeld: For reasons both technical and patient-specific, rates of incisional hernia after laparoscopic colorectal surgery remain high, typically occurring at the extraction site rather than the smaller port sites. Recent literature has suggested that transverse, muscle-splitting incisions for specimen extraction are associated with lower hernia rates (e.g. Surg Endosc 2011;25:1031-1036 and Am J Surg 2013;205:264-267). This is a retrospective, single-center database review of 11 years of laparoscopic colorectal surgeries at the Cleveland Clinic. While the overall hernia rate was only 7.2% at a mean followup of 6 years in this cohort, suggesting that the database did not capture all hernias, the authors did discover that periumbilical midline incisions had a much higher rate of hernia than Pfannenstiel incisions (HR=12.7). For left-sided resections, a low-transverse extraction site is therefore preferred. For right-sided resections, this becomes more difficult, but a transverse incision in the midline or right upper quadrant should be considered.

Article: Natural orifice specimen extraction with single stapling colorectal anastomosis for laparoscopic anterior resection: feasibility, outcomes, and technical considerations. Saurabh B, Chang SC, Ke TW, Huang YC, Kato T, Wang HM, Tzu-Liang Chen W, Fingerhut A. Dis Colon Rectum. 2017 Jan;60(1):43-50.
Dr. Steven Wexner: Numerous recent studies have confirmed the dangers of applying multiple staple firings across the distal rectal remnant prior to construction of distal colorectal or coloanal anastomosis. In order to help avoid this problem, the authors described natural orifice specimen extraction with single stapling in the February 2017 issue of Diseases of the Colon and Rectum. In order to perform this technique, this distal resection margin was identified and the rectum lumen included occluded with an intracorporeal free tie #1 silk suture proximal to the proposed line of rectal division to prevent contamination. After irrigation, the rectum was divided and prior to extraction a transanal endoscopic operation port (TEO® Transanal Endoscopic Operations, Karl Storz Endoscopy America, El Segundo, California) or an Alexis® wound retractor (Applied Medical, Rancho Santa Margarita, California) was placed. An intracorporeal purse-string was then created. After specimen extraction, the anastomosis was performed in the usual fashion. The authors compared 82 patients in whom the single stapled technique was employed with 106 patients who underwent double stapling. The single stapling group required less Meperidine, had more rapid return of bowel function, and shorter hospital stay–without any differences in the rates of anastomotic leak. The authors concluded that the transanal endoscopic operating platform can be a useful alternative to permit transanal purse-string placement in cases of longer rectal stumps and that the Applied Medical platform was useful in patients with shorter stumps. These techniques help us continue to evolve in our quest to decrease the trauma and the morbidity of surgery and especially the hazards of multiple distal stapler applications.


Article: The impact of different surgical techniques on outcomes in laparoscopic sleeve gastrectomies: the first report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). Berger E, Clements R, Morton J, Huffman K, Wolfe B, Nguyen, N, Ko C and Hutter M. Annals of Surgery 2016 September; 264(3): 464-473.
Dr. Jonathan Thompson: This is the first publication from the MBSAQIP registry, representing 189,477 sleeve gastrectomy cases performed by 1634 surgeons from 2012 to 2014. The authors analyzed sleeve gastrectomy technique variants and associations with 30-day morbidity and 1-year effectiveness outcomes.
There are many factors that are not measured in MBSAQIP, such as distance of the staple line from the incisura angularis, distance of the staple line from the gastroesophageal junction, type of buttress material used and where it was used, oversewing technique employed, type of stapler and cartridge selection, reattaching the omentum to the greater curve of the sleeve and the technique employed, hiatal hernia repair and technique employed, resultant volume of the sleeve under a distension pressure, and the use of fibrin sealant. There are also many factors that are unmeasurable, such as the amount of tension/stretch placed on the stomach during stapling, degree of bougie ’hugging’ during stapling, and presence of zig-zags, twists, or spirals in the staple line. Despite the limitations of the data set, we are a bit closer to answering a few important questions: What is ideal sleeve gastrectomy anatomy and what adjuncts are useful when creating it? The findings tell us a couple of things regarding the anatomy of a sleeve: 1) it provides evidence that a larger sleeve is probably safer and more effective for weight loss (assuming bougie size approximates sleeve size; bougie size ≥ 38 had fewer leaks; bougie size ≥ 40 had better 1 year BMI reduction); and 2) it provides evidence that antral preservation (distance from pylorus ≥ 6) is associated with greater weight loss at one year. Many surgeons use staple line reinforcement to protect against leak, so finding that staple line reinforcement was associated with a higher leak rate in the largest sleeve gastrectomy data set analyzed to date may cause some surgeons to question its utility in their practice. This study and the analyses that will follow the release of the MBSAQIP Participant Use File will hopefully give surgeons the confidence to change their practice if a change is necessary.

Article: Transoral outlet reduction for weight regain after gastric bypass: long-term follow-up. Kumar N, Thompson CC. Gastrointestinal Endoscopy 2016 Apr;83(4):776-9.
Dr. Manoel Galvao Neto: The Endolumenal Roux-en-Y gastric bypass revision is gaining momentum with the use of full-thickness suture devices that allow for a more durable procedure than previous ones. The duration of the procedure was always the Achilles tendon. Among revisional bariatric procedures, the endoluminal procedures each had at least one prospective randomized trial published, pointing to its efficacy over a control group, but only at 1 year and using a non-full-thickness suturing device.
In the current paper, durability is proven at 3 years follow-up. As usual, caution should be taken in translating this paper to clinical practice as it is a single reference center report and needs to be reproducible.
As bariatric surgery has become a mature field, its blessings and failures have become known as well. For RYGB, there is an expected 15-20% weight loss failure rate; some of those patients can be considered for a revisional procedure, especially the ones who lost their "ideal” proximal bariatric anatomy, having its pouch and anastomoses enlarged; the growing numbers of endolumenal revision have a good safety profile with results similar to revisional surgery. This may be establishing a trend on at least trying to revise endolumenally first.

Article: Outcome of peroral endoscopic myotomy (POEM) for treating achalasia compared with laparoscopic Heller myotomy (LHM). Peng L, Tian S, Lu L, et al. Surg Laparosc Endosc Percutan Tech 2017; 27:60-64.
Dr. Rees Porta: Clinical use of POEM was reported back in 2010, yet there is no data published with any patient followup greater than one year. Dr. Peng and colleagues published their experience comparing outcomes between POEM and LHM with followup in both groups well over 3 years. This was a non-randomized retrospective trial in which the authors state they primarily selected patients for POEM; however, patient characteristics (age, gender, previous treatments, duration and severity of symptoms) were not statistically significant between the groups. Of note, the authors did not use manometry (HRM) before or after treatment and their population seemed to have less GERD (7%) and shorter myotomes (7cm) than other publications. Outcomes were based on Eckardt, GerdQ, and SF-36 QOL scores. Although this study has its limitations, it shows that POEM outcomes are durable and comparable to the LHM at 3 to 4 years followup. Randomized trials incorporating HRM and longer-term followup are needed, but these preliminary studies are encouraging that POEM will prove to be an effective long-term treatment option for achalasia.

Article: Skrobić, Ognjan, Aleksandar Simić, et al. Significance of Nissen fundoplication after endoscopic radiofrequency ablation of Barrett’s esophagus. Surg Endosc 2016;30(9):3802-3807.
Dr. Bill Richards: This was a review of the prospective clinical database on patients with Barrett’s esophagus (BE) who underwent radiofrequency ablation (RFA) of BE and then were either treated with daily proton pump inhibitors (PPI) or underwent laparoscopic Nissen fundoplication (LNF). The authors found that in the patients with the BE length greater than 4 cm who treated with RFA and LNF had a much lower recurrence rate (25%) than patients who underwent RFA and PPI treatment (100% recurrence). The authors concluded that patients undergoing RFA ablation of BE with long segments of BE and who have hiatal hernias > 3 cm should undergo LNF as a first line treatment after successful RFA to prevent recurrence of the BE.
Article: Long-term incidence of contralateral primary hernia repair following unilateral inguinal hernia repair in a cohort of 32,834 patients.
Zheng R, Altieri MS, Yang J, Chen H, Pryor AD, Bates A, Talamini MA, Telem DA. Surg Endosc. 2017 Feb;31(2):817-822.
Dr. Ajita Prabhu: I like this article because when we do laparoscopic inguinal hernia repair, sometimes we may see a small hernia on the other side. This article addresses the issue of what to do with a contralateral inguinal hernia, and suggests that there may be certain patient populations that can benefit from repair of that incidentally identified inguinal hernia.

Article: Long-term recurrence and complications associated with elective incisional hernia repair. Kokotovic D, Bisgaard T, Helgstrand F. JAMA. 2016 Oct 18;316(15):1575-1582.
Dr. Dana Telem: This is an interesting article investigating the long-term recurrence and mesh-related complications in a registry-based nationwide cohort study. The study found that while primary repair of incisional hernia is associated with a higher risk of recurrence and reoperation in 5 years, this benefit is offset by mesh-related complications. This represents important data for use when counseling patients regarding hernia repair.


Vol. 8 No. 10
Welcome to the February issue of MISS E-News! It’s an exciting month for us because this is the month of the MISS Symposium in Las Vegas. With more than 40 faculty, and presentations that range from clinical practice research and guidance to debate panels on the latest procedural advances in surgery, this Symposium promises to be the most current educational meeting of the year.

The 2017 MISS will also feature two keynote addresses, one from Dr. Daniel B. Jones, the incoming President of SAGES whose interview was featured in last month’s E-News, and a second keynote address with Dr. Kevin Hall.

Dr. Hall is the tenured Senior Investigator at the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK), one of the National Institutes of Health (NIH). His research interests are the regulation of food intake, macronutrient metabolism, energy balance, and body weight, and his laboratory performs experiments in humans and rodents and develops mathematical models and computer simulations to help design, predict, and interpret the experimental data. Dr. Hall is the recipient of the NIH Director’s Award, the NIDDK Director’s Award, the E.V. McCullum Award from the American Society for Nutrition, the Lilly Scientific Achievement Award from The Obesity Society, and the Guyton Award for Excellence in Integrative Physiology from the American Society of Physiology. His award-winning Body Weight Planner has been used by millions of people to help predict how diet and physical activity dynamically interact to affect human body weight.

His keynote will address some critical biological findings he has discovered in his long-term research on past participants of the reality television show, The Biggest Loser. I hope you enjoy my short interview with Dr. Hall, as well as the critical article recommendations that follow it from some of the most talented clinicians in surgery. New contributor faces include Michael Schweitzer, Rees Porta, Sean Langenfeld, and Dmitry Oleynikov.

See you in Vegas at MISS! — Colleen Hutchinson

Colleen: If participants of the television program The Biggest Loser now have slower metabolisms today and burn fewer calories at rest than before the show began, patients who suffer from obesity might feel afraid to undergo the lifestyle and dietary changes seen in the show, because they also might risk ending up in a worse place metabolically than their current status. Given what you have found in the long-term research of show participants, as well as other efforts in which you are involved, what would you say to these patients–and their doctors–in terms of how they should view the potential for long-term weight loss success?

Dr. Hall: The Biggest Loser intervention was extreme in terms of both the quantity of exercise and the degree of calorie restriction, and resulted in a slowing of metabolic rate that amounted to several hundred calories per day. I wouldn’t recommend that kind of weight loss program to anyone since it is clearly unsustainable. People undertaking more realistic lifestyle and diet changes will not experience such large changes in metabolism and should not be discouraged from engaging in sustainable, healthy changes in diet and lifestyle. Success should be determined based on long-term maintenance of the healthy diet and lifestyle changes regardless of the degree of weight loss achieved. I worry that focusing on large amounts of weight loss as the sole measure of success may lead people to abandon changes that improve their health.

Colleen: Do you see more potential for success with current and emerging endoscopic, surgical and/or pharmacological therapies than you have seen with the dietary and lifestyle modifications to which the The Biggest Loser participants adhered?

Dr. Hall: I’m neither a surgeon nor a physician, so I won’t pretend to understand the subtleties of the various procedures or pharmacotherapies. However, we did a study in 2014 where we retrospectively pair-matched 13 patients undergoing Roux en-Y gastric bypass surgery (RYGB) to Biggest Loser contestants who had lost similar amounts of weight. The RYGB surgery patients lost weight more slowly than the Biggest Loser contestants, and their metabolic rates fell by a similar amount 6 months after surgery. However, 1 year after the surgery, the RYGB patients had metabolic rates that were appropriate for their new body size, whereas 6 years after the competition, the Biggest Loser contestants regained most of their lost weight and continued to experience reduced metabolic rates. We don’t know if these disparate results were because of something special about the surgery, something damaging about the Biggest Loser competition, or both. (Article: Metabolic adaptation following massive weight loss is related to the degree of energy imbalance and changes in circulating leptin. Obesity (Silver Spring). 2014 Dec; 22(12): 2563–2569.)

Colleen: There are ongoing global efforts to solve this puzzle and its various components—research focusing on the mechanisms of action in metabolic and bariatric surgery, research such as yours focusing on resting metabolism and basic biology of the body, endocrine research surrounding the role of hormones such as ghrelin and leptin–as well as the development and remission of type two diabetes with certain therapies, and pharmacological research into approaches that have met with success and failure. With all of this research in play against the disease of obesity, do you feel this is a solvable puzzle?

Dr. Hall: Obesity research is progressing at a rapid pace and we are learning more and more each day about its biological, social, and environmental drivers. I am highly optimistic that this research will lead to better interventions that improve the lives of people with obesity.

Colleen: Thanks for your time, Dr. Hall!


Article Recommendations
Article: Clinical practice guideline for the management of anorectal abscess, fistula-in-ano, and rectovaginal fistula. Vogel J, Johnson E, Steele S, et al. Dis Colon Rectum. 2016; 59: 1117-1133.
Dr. Rees Porta: From the American Society of Colon and Rectal Surgeons comes these updated practice guidelines for the management of anorectal abscess and the subsequent fistula(s) that will be present in up to 70% of cases. The authors give us GRADE-system recommendations based on the most up-to-date evidence. Notable changes since the prior publication in 2011 includes what appears to be a shift toward the endoanal advancement flap and the LIFT procedure, and away from the fibrin glue and fistula plug for the treatment of complex fistula-in-ano. Also, now included in this guideline is a section on rectovaginal fistula. These societal recommendations, which are evidence-based and easy to follow, are an invaluable tool for the general surgeon managing this complex but common disease.

Article: Diagnostic accuracy of procalcitonin and C-reactive protein for the early diagnosis of intra-abdominal infection after elective colorectal surgery: a meta-analysis. Cousin F, Ortega-Deballon P, Bourredjem A, et al. Ann Surg 2016;264(2):252-256.
Dr. Sean Langenfeld: Enhanced recovery pathways for colorectal surgery offer many advantages to patients and surgeons alike. However, concern exists that earlier dismissal from the hospital may hinder the surgeon’s ability to promptly identify and treat postoperative complications such as anastomotic leak. Several studies have focused on the inflammatory markers C-reactive protein and procalcitonin as routine tests on postoperative Days 3 and 4 to determine whether or not it is safe to discharge patients home. This well-designed meta-analysis concludes that both CRP and procalcitonin are useful in detecting postoperative intra-abdominal infection, and that a serum CRP less than 130 mg/L on postoperative Day 3 has a negative predictive value of 96.7%, indicating it is safe to discharge the patient without concern for leak. Of course, this is specific to patients doing well after surgery, and should not replace clinical judgment when there is adequate suspicion for leak.

Article: Clinical outcomes of reoperation for failed antireflux operations. Wilshire CL, Louie BE, Shultz D, Jutric Z, Farivar AS, Aye RW. Ann Thorac Surg. 2016 Apr;101(4):1290-6.
Dr. Dmitry Oleynikov: Anti-reflux surgery has proven to be feasible and effective in the control of esophageal symptoms. However, symptom recurrence has been reported in 33% of patients who undergo this procedure. This study addressed perioperative outcomes, esophageal symptom resolution, and quality of life of patients who underwent revision anti-reflux surgery. The authors compared the differences in outcomes between patients who had their first revision versus a second or greater revision, and concluded that the last group is associated with less improvement of quality of life. Therefore, patients who need a second or greater revision should be considered for other procedures, such as short colon interposition or Roux-en-Y gastric bypass.

Article: Functional and anatomic esophagogastric junction outflow obstruction: manometry, timed barium esophagram findings, and treatment outcomes. Clayton SB, Rupal Patel R, Richter J. Clin Gastroenterol Hepatol. 2016 Jun;14(6):907-11.
Dr. Bill Richards: The authors describe the clinical features and treatment outcomes from a group of 49 patients diagnosed with esophagogastric junction outflow obstruction (EGJOO). They first separate into mechanical etiologies (strictures and hiatal hernia) or functional EGJOO. Botox injection and endoscopic dilation were used in some cases, but many required laparoscopic antireflux surgery with repair of the large hiatal hernia.

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Article: Development of a disease-based hernia program and the impact on cost for a hospital system. Krpata DM, Haskins IN, Rosenblatt S, Grundfest S, Prabhu A, Rosen MJ. Ann Surg. 2016 Nov 30. [Epub ahead of print]
Dr. Michael Schweitzer: The Hernia Program at the Cleveland Clinic Foundation developed guidelines for the use of mesh based on CDC wound classification at their institution. They developed a protocol that minimized the use of expensive biologic mesh and instead used synthetic mesh with and without component separation. The cost savings for the institution was over $500,000 with a reduction of biologic mesh over 50% in class 1-3 wounds and 47% reduction in dirty class 4 wounds.

Article: Long-term recurrence and complications associated with elective incisional hernia repair. Kokotovic D, Bisgaard T, Helgstrand F. JAMA. 2016 Oct 18; 316(15): 1575-1582.
Dr. Rees Porta: Using the Danish Hernia Database, 5-year data is now available on 3,242 incisional hernia patients. Although this is a non-randomized cohort design (and subsequently subject to selection bias), it is a very large study with phenomenal long-term follow-up rates (reported 100% capture rate). The entire spectrum of repair types were included (primary vs. mesh, open vs. laparoscopic, as well as multiple varieties of mesh material and fixation techniques). The conclusion of the study is no major surprise; primary repair alone is associated with higher rates of recurrence when compared to mesh reinforcement. However, with long-term follow-up, the benefits attributable to mesh are offset somewhat by mesh related complications (4.5% mesh-related complication requiring surgery within 5 years – the risk increasing with mesh size). There is a paucity of available literature with long-term follow-up so it is important when choosing mesh reinforcement to be mindful that 1) the median time to mesh complication in this study was 11 and 24 months (open and laparoscopic respectively) and 2) the risk of mesh related complications increased with time.

Article: Per-oral endoscopic myotomy (POEM) after the learning curve: durable long-term results with a low complication rate. Hungness E, Sternbach J, Teitelbaum E, et al. Ann Surg 2016 Sep;264(3):508-17.
Dr. Bill Richards: This is a prospective study of 115 patients with achalasia who underwent POEM after each surgeon had completed 15 patients so that the results are after the learning curve was established. They found POEM to be a safe and effective treatment for achalasia but 45% of their patients had objective evidence of pathologic esophageal acid exposure post-POEM procedure. Overall, 92% of the patients reported success of the procedure. The authors acknowledge that patients with obesity and hiatal hernias should be offered Heller myotomy and laparoscopic gastric bypass and they noted that normal weight patients with hiatal hernias had a higher rate of pathologic GERD after POEM than those who did not.

Article: Rectal indomethacin reduces pancreatitis in high- and low-risk patients undergoing endoscopic retrograde cholangiopancreatography. Thiruvengadam NR, Forde KA, Ma GK, et al. Gastroenterology. 2016 Aug;151(2):288-297.e4.
Dr. Douglas Adler: This is a large retrospective study from UPENN on rectal NSAID for the prevention of post-ERCP pancreatitis. It is well done and conflicts with some other important studies on the topic, highlighting the lack of consensus on this critical issue. I wrote the accompanying editorial on this paper for Gastroenterology, highlighting the fact that the exact role of these agents in preventing post-ERCP pancreatitis remains unknown, and that whether or not they need to be used universally remains unclear, despite the fact that many (most?) doctors use these drugs in this manner.

Article: Management of gastric leaks after sleeve gastrectomy with endoluminal vacuum (E-Vac) therapy. Leeds SG, Burdick JS. Surg Obes Relat Dis. 2016 Aug;12(7):1278-1285. Epub 2016 Jan 21.
Recommendation 1
Dr. Matthew Kroh: Sleeve gastrectomy is the most commonly performed bariatric procedure in the United States. Changes in technique and a better understanding of the pathophysiology of sleeve gastrectomy have resulted in improved outcomes and lessened complication rates. Despite this, leak after sleeve gastrectomy imparts significant morbidity. Therapies for sleeve leaks include a focus on source control of sepsis and treatment of systemic manifestations. Endoscopic therapies including stents, clips, and suturing have demonstrated varying degrees of success in treatment of this complication. This article introduces a new concept in endoluminal treatment of sleeve complications, the endoluminal vacuum (E-Vac). E-Vac is an endoluminal technique of placing a sponge attached to a nasogastric tube into the cavity at the site of leakage. Negative pressure through the tube results in healing by secondary intention, and obliteration of the defect. Leeds and Burdick describe a series of 9 patients treated by E-Vac therapy. All patients developed a leak after sleeve gastrectomy and initiated therapy at a mean of 61 days after surgery. Each patient underwent a mean of 10.3 endoscopic procedures over the course of an average 50 days of therapy. All patients eventually had resolution of the leak confirmed radiographically. This small series describes another endoscopic method for treating a morbid complication after sleeve gastrectomy. Treatment time and number of interventions is quite intensive. However, as an adjunct to, or in lieu of, other procedures, E-Vac may be an option for a select group of patients, and the providers capable of treating this challenging problem.

Recommendation 2
Dr. Michael Schweitzer: This is a well written article describing one of the newer ways to manage a leak after sleeve gastrectomy where an endoluminal vacuum sponge is placed on a nasogastric tube and then transoral endoscopically guided through the leak opening into the abscess cavity. While their series is small, this is one possible way to treat a difficult leak after sleeve gastrectomy that may help to avoid reoperation or in some cases when reoperation fails and the leak reoccurs.


Vol. 8 No. 9
Welcome back and Happy New Year! It is my pleasure this month to feature an interview with two of my favorite people in surgery, MISS Conference Hernia Program Co-Director Dr. Guy Voeller and Dr. Michael Rosen. This article focuses on the Americas Hernia Society Quality Collaborative (AHSQC), which is a quality collaborative for hernia surgeons that is free to join. These two phenomenal hernia surgeons are not only at the forefront of hernia surgery research and advancement, but have also been involved in and developed recent healthcare initiatives that aim to improve several aspects of hernia care: the position of surgeons in the current healthcare environment, hernia surgery education, patient outcomes, hernia care processes, real world research efforts, and product development. I learned about the AHSQC last year and found the concept intriguing because participation seemed to be such a win-win for all relevant stakeholders in surgery—including surgeons, hospitals, patients, insurance companies, and product developers. Each group stands to benefit from the creation and success of the AHSQC, and the existing and potential future benefits of it are tremendous. Delving more into it, I found out that the AHSQC is a 501c3 supported by unrestricted industry grants. Currently there are three levels of supporters, which are Platinum (Intuitive Surgical); Gold (Bard, LifeCell, and Medtronic); and Silver (W. L. Gore).
Read on for some insights from Drs. Voeller and Rosen on this exciting effort. If you don’t know much about the AHSQC but practice hernia surgery, this interview is a must-read for you.
Enjoy the first article recommendations of 2017 from some thought leaders in minimally invasive surgery, and we hope to see you in Las Vegas for MISS next month!

—Colleen Hutchinson

AHSQC Interview
What is the AHSQC?
Dr. Voeller: The definition of the AHSQC (www.ahsqc.org) is contained in its initials–Americas Hernia Society Quality Collaborative. It is a quality collaborative. That may sound simple but its purpose is to improve the quality of hernia repair by collaboration amongst surgeons. This is what Benjamin Poulose and Michael Rosen had in mind when they came up with the idea of the AHSQC. As we are trying to switch from a quantity-based healthcare system to a quality-based one, it is important that surgeons are the ones who determine what is true quality. Hospitals, insurance companies, and entities are judging us on their quality metrics, and these groups are the least likely to know what true quality is or is not. The AHSQC enables surgeons to determine quality. In addition, another purpose of the AHSQC is to help those surgeons who may be having trouble and/or are on the lower end of the bell curve to improve their quality in a non-confrontational or punitive environment.

What does it entail on an individual surgeon/program level in terms of process and cost?
Dr. Voeller: Membership in the AHSQC is free. Any surgeon who wishes to join must be a member of the Americas Hernia Society (AHS), which costs $160 per year. There is no other associated cost with joining and actively being part of the Collaborative. Once a surgeon joins, the surgeon’s hospital will then enter into an agreement with the AHSQC regarding sharing and entering of patient data. This can turn out to be one of the more lengthy parts of the process and probably is the most significant hurdle for an institution that wants to participate in the quality collaborative. Lawyers are involved and, as always, this can take some time to work through the various systems. Once everything is approved, the individual surgeon will have to enter the hernia data on a case-by-case basis into the software of the collaborative. Normally when a surgeon finishes an operation, he or she has to speak with family, enter postoperative orders, and dictate an operative report. But it is best to enter this case data into the AHSQC database when the case is first completed. While this will add 3 to 10 minutes per case (typically 5 or less if you enter the data right after the case and closer to 10 if you are doing it at a later time when one must go back and find all the answers), and can be difficult for a busy surgeon to accomplish day in and day out, it is well worth the time in the long run.
It is important to note that maintaining the AHSQC as a free resource for surgeons really depends on participation; the more surgeons participate, the higher chance this will be able to remain free.
So to recap, in terms of cost, total cost is free if you are an AHS member, and cost of time is a couple minutes of time for data entry after each case.

Where are you now in terms of development?
Dr. Voeller: I know that Ben and Mike want to increase surgeon and institution numbers because that is the key to the success of the collaborative. Presently there are almost 200 surgeons with a total of almost 14,000 patients entered. There are about 400 new patients entered every month. This number will increase significantly when inguinal hernia becomes part of the collaborative this month.

What are the advantages for surgeons in joining the AHSQC, especially with Value Based Purchasing being enforced January 2017?
Dr. Rosen: There are many advantages to surgeons who join the AHSQC. First, you are actually able to track your own outcomes and compare yourself to a larger group in real time. This allows you to see what you are doing well, and what you might want to improve on in the future. This is often the first time many of our surgeons are able to actually see how they are doing amongst their peers, and it is very powerful. Second, you are able to have real time data analytics to show your institution the exact value that you as an individual surgeon provide to their enterprise in the care of hernia patients. With the growing need to measure and report quality outcomes, it is critical for surgeons to control their own destiny by being involved in the data collection and outcome measures on which they are being judged. Waiting and hoping that your institution will do this for you in a fair and balanced means is often met with disappointment. Third, with value based payment adjustments starting this month, many surgeons are going to feel the 2% payment cut for Medicare patients if they are not deemed high quality surgeons. The AHSQC has been extremely proactive in this regard, and is now recognized by CMS as a qualified clinical data registry (QCDR), which basically means that your data in the AHSQC can be used to avoid these severe payment cuts. Fourth, we have a world class coaching system where collaborative-nominated surgical coaches are available to coach other surgeons via a cloud-based system to improve their outcomes and streamline their care processes.
Finally, it is an amazing experience to be part of a collaborative. For many surgeons out in practice, it can be very lonely and isolating. Being part of something that is much bigger than just one surgeon is a special experience, and every surgeon in our collaborative makes a difference.

What are the global benefits of the Collaborative?
Dr. Voeller: The global benefits to the Collaborative have the potential to be tremendous. First, and most importantly, it will allow us to find out what techniques, meshes, methods of mesh fixation and other issues in hernia repair work or don»t work. Also, part of the Collaborative is a mentoring and teaching function that will help educate surgeons on improving their techniques for hernia repair. Surgeons can look at their data and have access to other data on the Collaborative to help not only in education, but improvement in outcomes. In addition, research can be and has been done using the data on the Collaborative. It is well known that randomized prospective trials can leave many more questions unanswered than answered due to the difficulty in controlling variables. The Collaborative allows ready access to a tremendous amount of data to analyze what»s going on in the real world. The research potential is huge. Lastly, the companies are very interested because the FDA has said if data gathered on the Collaborative shows a product can be used safely in an instance where it may not have approval, the FDA may approve the new indication solely based on the data from the Collaborative. That is a totally new paradigm that helps patients, hospitals, and new product developers.

Speaking of data, what happens to members’ individual data and how is the data being used on a national level to help surgeons?
Dr. Rosen: The real power of our quality collaborative is that an individual surgeon can make a tremendous difference and their outcomes and experience counts. By pooling data from all practice patterns, and all levels of experience, we are able to see what is actually happening in the real world. As Guy mentions, all too often the peer review publications come from centers with high volumes and specialized practices, and this often doesn’t represent data that is relevant to most surgeons that are fixing hernias. In participating in this endeavor, surgeons are able to level the playing field and let their experience count.
In practice, each surgeon has access to their own data through our export function and can see their own results compared to the collaborative real time. Their data is also used as an aggregate analysis on the collaborative level. We have a publications committee that reviews protocols from any surgeon that wishes to analyze and perform research on our data and is a member of the AHSQC. This allows all of our collaborative surgeons to also have access to the larger data set to answer key questions in hernia surgery. In a few short years, we have been able to answer critical questions about the effectiveness of epidural analgesia after ventral hernia repairs, utilization of chlorhexadine scrubs prior to ventral hernia repairs, and outcomes of patients receiving bowel preparation before ventral hernia repairs, and have developed a validated readmission reduction tool for institutions to implement to reduce costly readmissions.
We are excited to report that participation in this collaborative is now recognized by the American Board of Surgery as acceptable for fulfilling the Maintenance of Certification Part IV requirement. As mentioned, we have also been recognized by CMS as a QCDR, which is critical in the quality payment program of CMS that started this month.

What are some of the major barriers to joining the AHSQC?
Dr. Rosen: There are a few barriers to joining the AHSQC, some of which are perceived and some are real and due to the fact that the system in which we practice medicine is not really ready for us to work together on a large scale to improve the care of our patients. It’s worth going into detail about some of these issues to provide surgeons a better understanding of what it takes to become a part of a collaborative.
Perhaps the most important barrier to discuss is the surgeons themselves. We simply were not taught to collaborate with our fellow surgeons. In fact, we were taught to compete against the fellow surgeon at all costs. This bitter competition has led to distrust in collaboration. It is so unfortunate, because while we do not work together as a group, many others are coming together and they are organized, and often don’t have the surgeon’s or patient’s best interest in mind. No one has a closer bond with their patients than a surgeon, and we need to be at the table when important decisions are being made. Surgeons must move past this discomfort with collaboration in order to be successful in today’s healthcare climate.
The second barrier to joining a collaborative is the HIPPA laws that currently make sharing of data extremely difficult amongst different surgeons in different institutions. Depending on what your practice type is, a contract lawyer from your institution must sign off on the agreement to allow us to share data. Despite over 200 institutions across the country already signing that contract, we have found that many hospitals also resist joining this endeavor simply because they are not equipped to share data for the greater good of their patients, and instead fear public reporting, or misuse of their data. It is unfortunate, because so many groups with much less accurate administrative data are already publically reporting on all of us, for which we have no say, validation, or basic risk adjustment to control the accuracy of what is being released.
Hopefully as the quality collaborative movement grows, the inappropriate resistance that many institutions put forth will be eliminated. It is also important that surgeon champions be ready to fight for their right to know their own risk adjusted outcomes, which is a very powerful position to be in when negotiating with your institution.
The final barrier is the perceived amount of time that is required to participate in this effort. It is important to point out that half of our membership is composed of private practice surgeons. You do not need a fleet of data abstractors to complete the data entry. This is surgeon-entered data and takes roughly 3-10 minutes per case. This is well worth the effort as we can now answer key questions that have plagued hernia surgeons for years, and have a seat at many tables to begin to shape some of the policy decisions involved in the practice of surgery.


Suggested Readings:
Article: Bariatric Surgery Outcomes in US Accredited vs. Non-Accredited Centers: A Systematic Review. Azagury D, Morton JM. J Am Coll Surg 2016;223(3):469-77. https://www.ncbi.nlm.nih.gov/pubmed/27423398

Dr. Shanu Kothari: The authors have provided an excellent history of accreditation within the American Society for Metabolic and Bariatric Surgery (ASMBS) in the introduction of their article. They reviewed the baseline requirements for accreditation that goes far beyond a minimum volume requirement. They reviewed 13 papers on the topic for a total of 1.5 million patients, and compared the outcomes at accredited centers vs. non-accredited centers. Ten of the 13 papers demonstrated a considerable benefit at accredited centers for risk-adjusted outcomes. Specifically, 6 of 8 papers showed a reduction in mortality at accredited versus non-accredited centers and 8 of 11 showed reductions (albeit small) for morbidity at accredited centers. Moderate improvements in morbidity but significant improvements in mortality imply that accredited centers have the appropriate personnel and resources to treat patients in a timely fashion without letting them succumb to what is deemed "failure to rescue" in the literature. All of the studies reviewed were retrospective, large cohort studies that used a variety of databases (Centers for Medicare & Medicaid Services database, Nationwide Inpatient Sample database, University Health System Consortium database, etc.), each of which have inherent limitations. Hopefully, a day will come when the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) will be the definitive accrediting body and all third-party payers will honor that designation when it comes to reimbursement.

Article: The Role of Metabolic Surgery on Blood Pressure Control. Schiavon, CA, Drager LF, Bortolotto LA, et al. Curr Atheroscler Rep 2016:18(8):50. https://www.ncbi.nlm.nih.gov/pubmed/27324638

Dr. Ricardo Cohen: Metabolic surgery is not only about diabetes. This interesting review approaches the benefits of bariatric/metabolic surgery on blood pressure (BP). So far, most published trials did not pay attention to hypertension, examining it only as a secondary endpoint. The observational series report diverse outcomes, with some reporting BP remission, BP control, or BP unchanged, while some randomized controlled trials (RCT) showed good outcomes with reduction of medication as easier control. This non-glycemic endpoint is important to be taken into account, because the main goal of metabolic surgery is to reduce cardiovascular risk. This group of authors are running the first RCT to address this important question, comparing the Roux-en-Y versus the medical treatment gastric bypass to treat obese patients with steady hypertension (the GATEWAY study). This is another interesting effect of metabolic/bariatric surgery that, combined with other outcomes (glycemic and lipids), is responsible for the long-term decreased all cause and cardiovascular mortality after surgery.

Article: Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial. Fleshman J, Branda M, Sargent DJ, et al. JAMA 2015; 314(13):1346-55.

Article: Effect of Laparoscopic-Assisted Resection vs Open Resection on Pathological Outcomes in Rectal Cancer: The ALaCaRT Randomized Clinical Trial. Stevenson AR, Solomon MJ, Lumley JW, et al. JAMA 2015; 314(13):1356-63.

Dr. David Etzioni:
These two studies, published in the same issue of the Journal of the American Medical Association (JAMA), randomized patients with stage II/III rectal cancer to laparoscopic versus open rectal cancer surgery. The endpoint for both of the studies was a composite endpoint–successful resection–which included: 1) a macroscopically complete mesorectal specimen; 2) a negative (≥ 1 mm) circumferential radial margin; and 3) a negative (≥ 1 mm) distal resection margin. Sample size accrual was sufficient in each of these studies (462 in the ACOSOG study and 402 in the ALaCaRT study) to achieve the a priori goals. The statistical endpoint was non-inferiority, with non-inferiority margins set at -6% in the ACOSOG study and -8% in the ALaCaRT study. Non-inferiority is met if the confidence intervals for the endpoint (successful resection) do not encompass these margins. In both of these studies, there was a failure to establish non-inferiority of the laparoscopic technique compared with open surgery (successful resection in ACOSOG = 81.7% for lap, 86.9% for open; ALaCaRT = 82% for lap, 89% for open). The implication is that the laparoscopic approach is oncologically inferior to the open approach.
Assimilating these results into appropriate changes in practice will challenge the field of colorectal surgery. Should the minimally invasive approach to rectal cancer care be abandoned? Doing so would be throwing out the baby with the bathwater. There may, however, be a greater role for stratifying the surgical approach for patients with rectal cancer. Patients with cancers that are more technically challenging may be better served with an open approach. A detailed paradigm to determine this is impossible to develop because of the significant differences in the skill sets available to particular surgeons. Long-term results of each of these studies will characterize the relationship between elements of successful resection and long-term outcomes. For now, the decision to use minimally invasive techniques in patients with rectal cancer should be made cautiously, and with a deep appreciation of the importance of appropriate oncologic principles.

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Article: Outcomes for trainees vs. experienced surgeons undertaking laparoscopic antireflux surgery - is equipoise achieved? Brown C, Smith L, Watson D, Devitt P, Thompson S, Jamieson G. J Gastrointestinal Surg 2013;17(7):1173–1180. https://www.ncbi.nlm.nih.gov/pubmed/23653375

Dr. Robert Lim: We continue in an era where surgical quality is marked by long-term surgical outcomes, and this paper highlights how experience may play a factor in these outcomes. There is some uncertainty as to whether or not laparoscopic antireflux surgery, which would constitute both GERD and hiatal hernias, should be considered among the basic surgical skills of the general surgeon. This paper highlights that the short–term outcomes are equivalent, but long–term ones benefit from more experience. Other than reoperative patents, there is no distinction in the study between complicated and uncomplicated patients, and sub–groups were too small to make definitive conclusions about outcomes. However, there was significant advantage in reoperation rates, need for dilation, and patient satisfaction in the more experienced group. Consequently, I believe that the complex patient would benefit from more experience and the uncomplicated ones would have high quality outcomes regardless of the experience of the surgeon.

Article: Long–term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux. Ganz RA, Edmundowicz SA, Taiganides PA, et al. Clin Gastroenterol Hepatol. 2016;14(5): 671–677. https://www.ncbi.nlm.nih.gov/pubmed/27760265

Dr. Bill Richards: This is a five–year safety and efficacy study on 100 patients who underwent magnetic sphincter augmentation (MSA) for treatment of severe GERD. There were no device erosions, migrations, or malfunctions and the median preoperative GERD–HRQL of 27 fell to 4 after 5 years of implantation. The authors conclude that the MSA procedure is safe and effective after 5 years of follow–up.

Article: Standard laparoscopic versus robotic retromuscular ventral hernia repair. Warren JA, Cobb WS, Ewing JA, Carbonell AM. Surg Endosc. 2017 Jan;31(1):324-332. https://www.ncbi.nlm.nih.gov/pubmed/27287903

Dr. Ajita Prabhu: Hernia repair is the fastest growing market for the currently available robotic platform. While several other articles have been published on this topic, this article is the first of its kind to compare the robotic approach with laparoscopy in terms of postoperative narcotics requirements, operative time, wound morbidity, length of stay, and cost. This is important because, while it is still early, there is some indication that at least for certain populations there may be some advantage to robotic retromuscular ventral hernia repair. It is also important to interpret these early results with caution, as we certainly have a long way to go with demonstrating that this is a reproducible and generalizable technology, and also that it makes sense from a cost standpoint.

Article: Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias. Rona K, Reynolds J, Schwameis K, et al. Surg Endosc 2016:1-7.

Dr. Bill Richards: This is a study of 192 patients who underwent magnetic sphincter augmentation (MSA) at one institution comparing the results of after MSA with hiatal hernia repair in patients with hiatal hernias greater than 3 cm in size to MSA in patients with hiatal hernias smaller than 3 cm. Patients who had larger hiatal hernias repaired and MSA had better outcomes than the MSA without Hiatal hernia repair. These short-term results suggest MSA may be a good option even in patients with larger hiatal hernias.

Article: Endoscopic sleeve gastroplasty with 1-year follow-up: factors predictive of success. Lopez-Nava G, Galvao M, Bautista-Castaño I, Fernandez-Corbelle JP, Trell M. Endosc Int Open. 2016;4(2):E222-7. https://www.ncbi.nlm.nih.gov/pubmed/26878054

Dr. Marina Kurian: The endoscopic sleeve gastroplasty is a new procedure that is being taught worldwide. This is very good early data from a premier center and early adopter. It is clear that this is a procedure for a different group of patients—those who don’t qualify for surgery based on BMI and comorbidity but have obesity and would benefit from weight loss.

Article: Gastric per-oral endoscopic myotomy (POEM) for refractory gastroparesis: results from the first multicenter study on endoscopic pyloromyotomy (with video). Khashab MA, Ngamruengphong S, Carr-Locke D, et al. Gastrointest Endosc. 2016.

Dr. Matthew Kroh: Advances in endoluminal surgery have allowed for increasingly complex procedures to be performed more commonly. For example, per oral esophageal myotomy (POEM) for achalasia is routinely performed in specialized centers with excellent results. Endoscopic intra-mural surgical techniques have been applied elsewhere, too, including resection of submucosal lesions and division of the pylorus as a treatment for gastroparesis.
With a spectrum of causes including diabetes, post-surgical dysfunction, and idiopathic etiologies, gastroparesis is a rare but an increasingly frequent disease. Medical therapies exist with varying success rates, and surgical treatments include gastric electrical stimulation (GES), gastrectomy, and pyloroplasty. In this study, Khashab et al describe their experience with gastric per-oral myotomy (G-POEM), a new intramural technique for treatment of gastroparesis. In this endoscopic procedure, the pyloric sphincter is divided to allow for better gastric emptying without transabdominal surgical access. This multi-center study reports on 30 patients with refractory gastroparesis.
The technical success rate was 100% with a mean procedural time of 72 minutes. Mean myotomy length was 2.6 cm. Adverse events were rare. Objective postoperative evaluation was documented by gastric emptying studies, which were improved or normalized in 82% of patients.
Gastroparesis is a challenging disease process and, based partly on studies such as this, G-POEM may provide a less invasive, intra-mural technique for treatment. Further studies need to focus on the long-term durability of the procedure and quality of life metrics.

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