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Introduction
This month’s issue features an interview with Professor John Dixon, who is the MISS Metabolic/Bariatric Program Co-Director. Dr. Dixon is a critical contributor to clinical research in obesity and weight loss and a recognized leader on the topic of the adjustable gastric band. I’d like to thank Dr. Dixon for taking the time to share insights on the adjustable gastric band with us in this interview.
I hope you also enjoy this month’s article recommendations from thought leaders in minimally invasive surgery, brought to you by leaders at the forefront of research and innovation.
Also, as many of you have already seen, I’ve been conducting interviews with thought leaders while attending MISS in Las Vegas the past two years. One of this year’s interviews is with Samer Mattar, current President of ASMBS. In addition to other topics, I asked Dr. Mattar to specifically address the discussion surrounding sleeve gastrectomy versus gastric bypass. Watch this video to see Dr. Mattar’s interesting take on this debate, and also make sure to check out the two suggested bariatric suggested readings below, as both involve studies addressing the very same question: which one is better—sleeve or bypass? Enjoy!
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Professor John Dixon is a Professorial Research Fellow at Baker Heart and Diabetes Institute in Melbourne, an experienced clinician, and a leading global expert in obesity and weight loss. With over 300 quality peer-reviewed publications, he is one of the top researchers in the world in the fields of obesity, weight loss, morbid obesity, bariatric surgery, and bariatrics (Expertscape.com). Committed to improving clinical care through enhanced professional education, he has a busy international schedule presenting on obesity, obesity comorbidity, and weight loss.
How should general surgeons view or approach use of the laparoscopic adjustable gastric band as a tool of his or her bariatric surgical armamentarium?
Dr. Dixon: LAGB surgery is safe and effective, and complication rates are low when the band is placed and managed by those who are specifically and appropriately trained. The adjustability of the band is both its greatest attribute and its greatest risk. Placing the band is the easy part for skilled upper gastrointestinal (GI) surgeons. Placing it properly takes care and an acceptance to use proven standardized techniques. But adjusting the band and managing the individual patients takes detailed training, time, and commitment.
It should not be a surprise that these roles require completely different skill sets. Managing clinically severe obesity and its complications requires an indefinite chronic disease model of care. Laparoscopic adjustable band (LAGB) management sits perfectly with trans-disciplinary teams who provide chronic disease management, rather than the usual general surgical practice. Unless a surgeon can provide or access a skilled team that can both manage the band as well as the full range of requirements for managing a patient following surgery, they should not be placing bands or performing any form of bariatric metabolic surgery.
The skills of a surgeon are best used in the operating room performing or revising bariatric-metabolic procedures. Using surgeons to provide surgery is the best use of their time and will provide access to surgery for so many more of those in need. LAGB surgery provides the safest, high-turnover form of cost-effective surgery. Surgeons should work with teams that are designed to care for clinically severe obesity and its complications, including type 2 diabetes.
How has the role of the band as a treatment option for weight loss evolved since its creation?
Dr. Dixon: The band placement technique has been standardized. Our understanding of how it works has evolved from myth to reality. Burying the myths of the over-simplistic concepts of restriction and malabsorption for bariatric procedures has enabled a physiological approach to the mechanism of action and care. Band follow-up has been revolutionized and, as a result, post-placement care complication rates have plummeted, as has been recorded in recently published US multicenter series.
Over the last decade, bariatric-metabolic surgeons have largely dismissed the band. The inability to provide appropriate long-term care, perceptions of high complication rates, and lower overall weight loss than comparative procedures has led to the band being used by relatively few surgical groups. However, these groups along with their well-trained teams are achieving impressive results.
But there is an even bigger problem. At a population level, bariatric-metabolic surgery is not making an impact on the epidemic of obesity and its complications. Few want any type of surgery and even fewer have access to it. The uptake of any effective weight loss therapy beyond that of lifestyle is trivial; surgery, GI devices, pharmacotherapy and meal replacements are used by <5% of those who have an indication and are eligible for these therapies. As for any chronic disease management, combining effective therapies and scaling therapy up as needed provides the basis of logical care. Dismissing any safe, effective, cost-effective (even cost saving) treatment when we have so few therapies is driven by bias, stigma, discrimination, and ignorance. As The Obesity Society advocates, “We need every effective tool we can get our hands on.”
We need to embrace all effective evidence-based therapies and broaden their usage, and focus less on trying to design the perfect complex surgical procedure that will suit all and be attractive to very few.
What is the most debated aspect of adjustable gastric banding today?
Dr. Dixon: Debates in the bariatric-metabolic surgical domain generally embrace expert opinion and feelings rather than providing evidence-based decision-making. This is particularly evident for anything new as there is no quality evidence.
How often has expert opinion been found wanting? How often does an “advance” actually turn out to be a step backward? When unexpected evidence-based result is uncovered, how ready are we to accept it?
The band is now almost 25 years old. It is a regulated device, under regulatory control and scrutiny in numerous countries. The evidence base is extensive, clear, and reproducible. The band is safe, effective, and cost effective, and for many it is cost saving. To borrow from Mark Twain, “The reports of my (the band’s) death are greatly exaggerated.”
As we have all learned recently, fake news (lies) spreads faster than truth. Obesity is such a stigmatized condition that we can easily dismiss effective weight management therapies including surgery, devices, and pharmacological and dietary interventions as flawed and of little value. It’s a near universal fake truth. To date, there appears to be no duty of care to actively manage obesity, but there is when managing its complications!
Can you really imagine dismissing effective therapies for other chronic conditions? In managing diabetes, hypertension, serious mental illness, and cancer we, as clinicians, have responsibilities and a duty of care. We need the broadest range of therapies. Clinical inertia is characterized by not treating or not increasing therapy appropriately for a patient’s condition. In weight management, we would be embarrassed to use the term and we would have to admit clinical negligence with <5% of those with a clear indication receiving any effective medical (including surgical) therapy.
Debate itself is not the problem. Healthy debate that is informed and passionate will drive innovation and better health care for all. We are challenged, however, when debate and conflict is without a positive purpose.
Can you tell us the main points of your 2018 MISS presentation on gut microbiome and chronic disease, as well as its implications in bariatric surgery?
Dr. Dixon: The gut microbiome (GM) and its role in human health and disease are going through a renaissance of knowledge. The complex population of the GM follows the human life cycle from period of immaturity, to being mature and robust, through to greater frailty during senescence. Its role has expanded from nutrient digestion, extraction and synthesis to include eliminating pathogens, protecting gut-barrier function, and modulating immunity, metabolism and gut-brain signaling. Our environment has a major influence on our GM, or “inviroment,” and these changes are linked to chronic GI conditions, obesity and metabolism, allergy, autoimmune disease, and a broad range of chronic disease.
Association does not equate to causation and the issue of cause or consequence arises. As for environmental associations with human health, GM associations will require rigorous and broad-ranging study to establish causation.
This explosion of knowledge, enabled through the genomic advances, has opened the door to many potential interventions to benefit aberrant GM-human interaction. These include simple dietary changes, the development of specific functional foods, prebiotics, probiotics, and pharmacological interventions. Of course directly adding to the GM with another’s GM may hold great potential beyond managing Clostridium difficile.
There has been great interest in bariatric-metabolic surgical interventions in both humans and animal models to explore changes in the GM. To date, numerous studies have provided exciting insights but we lack robust reproducible findings at this time. The future holds great promise.
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Suggested Readings
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Bariatric
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Article: Is laparoscopic sleeve gastrectomy safer than laparoscopic gastric bypass? A comparison of 30-day complications using the MBSAQIP data registry. Kumar SB, Hamilton BC, Wood SG, Rogers SJ, Carter JT, Lin MY. Surg Obes Relat Dis. 2018 Mar;14(3):264-269
https://www.ncbi.nlm.nih.gov/pubmed/29519658
Dr. Jaime Ponce: Another great analysis of the largest database in bariatric surgery. More than 130,000 patients demonstrate the very low rate of complications and death for bariatric surgery comparable to other common procedures like laparoscopic cholecystectomy. This paper puts the risk into perspective when we compared bypass versus sleeve. Bypass had a twofold increased risk of complications and death compared to sleeve. This is consistent with other studies like SM-BOSS and SLEEVEPASS trials. Safety is not the only thing we need to look at when we offer a procedure to our patients, but it can give us a better indication of when the patient might not be able to tolerate a higher risk of complications. Both procedures offer a good option for patients.
Article: Effect of laparoscopic sleeve gastrectomy vs. laparoscopic Roux-en-Y gastric bypass on weight loss at 5 years among patients with morbid obesity. The SLEEVEPASS randomized clinical trial. Paulina Salminen, MD, PhD; Mika Helmiö, MD; Jari Ovaska, MD, PhD; et al. JAMA. 2018;319(3):241-254.
https://www.ncbi.nlm.nih.gov/pubmed/29340676
Dr. Dimitri Pournaras: This is a comparative randomized controlled trial of sleeve gastrectomy and gastric bypass performed in Finland. Weight loss was better after gastric bypass compared to sleeve gastrectomy, but the difference was not clinically significant and both procedures led to good weight loss. There was no difference in type 2 diabetes remission, dyslipidemia resolution, quality of life improvement, and late morbidity.
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Foregut
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Article: Primary paraesophageal hernia repair with Gore® Bio-A® tissue reinforcement: long-term outcomes and association of BMI and recurrence. Olson MT, Singhal S, Panchanathan R, et al. Surg Endosc. 2018 May 14. [Epub ahead of print]
https://www.ncbi.nlm.nih.gov/pubmed/29761272
Dr. Luke Funk: Mesh reinforcement of the crura during hiatal hernia repair is one technique that surgeons may use to decrease the chance of hernia recurrence. Bio-A® (Gore®) is one of the most commonly used types of mesh, possibly due to its bioabsorbable nature. This observational study described outcomes of nearly 400 patients who underwent a paraesophageal hernia repair (defined as >1/3 of the stomach herniated), which included a partial or total fundoplication, and onlay placement of Bio-A®. After more than 4 years of follow-up, nearly 16% of patients had a symptomatic hernia recurrence, and 8% required a reoperation. Interestingly, there were no differences in outcomes between normal weight and obese patients. These findings suggest that Bio-A® reinforcement of the hiatus is feasible and safe, although its effectiveness at reducing long-term hernia recurrence remains unclear.
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Hernia
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Article: Systematic review and network meta-analysis of methods of mesh fixation during laparoscopic ventral hernia repair. Baker JJ, Öberg S, Andresen K, Klausen TW, Rosenberg J. Br J Surg. 2018 Jan;105(1):37-47.
https://www.ncbi.nlm.nih.gov/pubmed/29227530
Dr. Luke Funk: There are multiple options for fixating mesh during laparoscopic incisional hernia repair: sutures, permanent or absorbable tacks, a combination of sutures and tacks, or fibrin glue. The optimal technique for mesh fixation is not known. This meta-analysis included 51 studies that were either retrospective with >50 patients or randomized trials comparing different mesh fixation techniques. The authors concluded that using sutures, with or without tacks, may lower recurrence rates (overall median follow-up was nearly 2 years) after laparoscopic ventral hernia and should be considered a standard technique. In contrast, using absorbable tacks alone was associated with a higher hernia recurrence rate and should be discouraged.
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Endoscopy
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Article: Feasibility of the TAMIS technique for redo pelvic surgery. Borstlap WA, Harran N, Tanis PJ, Bemelman WA. Surg Endosc. 2016;30(12):5364-5371.
https://www.ncbi.nlm.nih.gov/pubmed/27066971
Dr. Steven Wexner: Over the last several years, a variety of platforms have been described for transanal endoscopic surgery using both rigid and flexible platforms. Under the global heading of transanal endoscopic surgery, these include transanal endoscopic microsurgery, transanal endoscopic operating, and transanal minimally invasive surgery. While the majority of reports describe these techniques being used to resect neoplastic lesions and/or remove the rectum in its entirety, other uses have developed. Bemelman’s publication describes the use of transanal endoscopic surgery and in particular transanal minimally invasive surgery (TAMIS) as an access modality for patients requiring re-operative pelvic surgery. They described a group of 17 patients who had previously undergone either low anterior resection with colorectal or coloanal anastomosis or ileal pouch anal anastomosis. They successfully performed the TAMIS technique in 14 of the 17 patients, while 3 patients required a completion proctectomy with end stoma. The authors grouped their indications into anastomotic problems and pouch problems. Ten of the 13 patients with anastomotic problems had chronic presacral sinuses secondary to anastomotic leaks. Four patients had a heterogeneous variety of pouch-related problems. The authors successfully completed TAMIS with successful meeting with abdominal aspect in 15 patients, encountering only one intraoperative complication. All 14 patients in whom continuity was restored with the TAMIS approach underwent a hand-sewn anastomosis. Two patients (14%) developed an anastomotic leak, 5 patients (29%) were readmitted, and 4 patients (24%) developed a pelvic abscess that required reintervention. One patient developed a urethral stenosis. Ultimately, 71% of patients had continuity restored at the 6-month follow-up. The authors certainly challenge our ability to push the envelope with transanal endoscopic surgical methods.
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Colon
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Article: Randomized controlled trial of two alcohol-based preparations for surgical site antisepsis in colorectal surgery. Broach RB, Paulson EC, Scott C, Mahmoud NN. Ann Surg 2017;266:946-951.
https://www.ncbi.nlm.nih.gov/pubmed/28277409
Dr. Sean Langenfeld: Alcohol-based skin preps have previously been shown to decrease surgical site infection (SSI) in colorectal surgery. This is the first RCT to directly compare SSI rates between iodine-alcohol (Duraprep) and chlorhexidine-alcohol (Chloraprep), demonstrating no difference in SSI rates between the two competing products. There are a few limitations, mostly related to uncontrolled variables that impact SSI (preoperative antibiotic, bowel prep, normothermia, wound protectors, etc), but it is very well-designed overall. The study employed a blinded observer, and followed patients for 30 days after the operation. This is a very important detail since many SSIs are identified after discharge, and thus inpatient database studies often fail to capture these SSIs, underestimating the overall incidence.
Article: Multicenter, randomized single-port versus multi-port laparoscopic surgery (SIMPLE) trial in colon cancer: an interim analysis. Kang BM, Hyung JK, Kye BH, et al. Surg Endosc 2018;32:1540-1549.
https://www.ncbi.nlm.nih.gov/pubmed/28916955
Dr. Sean Langenfeld: This randomized trial demonstrates equivalent outcomes between single-port and multi-port laparoscopy for colon cancer. Baseline demographics, specimen quality, postoperative pain, and complication rates did not differ between the two groups. This can be interpreted in two ways: 1) SILS is safe for colon cancer surgery, or 2) SILS provides no measurable benefit over conventional laparoscopy for colon cancer. Data should also be interpreted with caution since all procedures were performed by specialists with expertise in laparoscopic colon surgery. Additionally, the mean BMI in both groups was 24, which is a cohort I have yet to encounter in my Midwest practice.
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Introduction
This month's issue features several interviews. All of the doctors you hear from in this month’s column are critical contributors to clinical research in new technologies in foregut surgery. I’d like to thank each contributor for taking the time to share insights on these new technologies with us in this interview.
I hope you also enjoy this month’s article recommendations from thought leaders in minimally invasive surgery, brought to you by leaders at the forefront of research and innovation.
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Dr. Peter G. Janu: Transoral Incisionless Fundoplication (TIF) with EsophyX
Dr. Janu is Director of the Reflux Center of Excellence for Ascension NE WI. Medical Director Surgical Services Calumet Medical Center Chilton WI.
Disclosures: Consultant for Endogastric Solutions, Inc.
What can general surgeons expect regarding new technology advances in foregut surgery?
Dr. Janu: As more comparative data becomes available, along with continued divergence from PPI medication, more patients will be seeking surgical treatment options because of the availability and efficacy of these newer advances.
How do you foresee these advances, techniques, or devices improving treatment options and patient outcomes?
Dr. Janu: I think there is a tendency for patients to wait until their situation has progressed to a point where it is quite advanced, and thus limits treatment options. Since these newer technologies have less morbidity and side effects, I think there will be a trend toward patients accepting definitive treatment options earlier in their disease state, and in doing so stop or delay any progression of the disease state and eliminate the long-term side effects of medical therapy.
For example, for patients without a significant hiatal hernia and reflux symptoms due to a dysfunctional gastroesophageal junction, a transoral incisionless fundoplasty (TIF) can performed with the EsophyX device without any incisions, and leave little if any long-term side effects. It’s a quick (25-30min) endoscopic procedure done outpatient under a general anesthetic that can provide good durable relief of regurgitation and reflux symptoms in properly selected patients, i.e. early in the disease spectrum. The procedure essentially creates an anatomically correct partial fundoplication endoscopically so any dysphagia or bloating symptoms are mitigated.
For patients that do have hiatal hernias associated with their reflux, our recent study of 99 patients presented at American Congress on Gastroenterology focusing on concomitant laparoscopic hiatal hernia repair with endoscopic fundoplication (TIF) showed it to be a safe and effective option at one-year follow-up. This would be an alternative treatment option for patients trying to find the lowest side effect profile.
What do you see as the most critical challenge foregut surgeons face today and why?
Dr. Janu: The hardest part of this disease is matching the patients’ degree of disease to the most appropriate treatment option. Newer minimally invasive options like TIF and LINX tend to be more effective for patients earlier in the spectrum of the disease state. With time and experience, surgeons will be able to more effectively counsel patients on the most appropriate treatment for the specific individual aspects of their reflux disease.
As it relates to treatment options for patients, what is the most critical need you face within your current surgical armamentarium?
Dr. Janu: The greatest challenge has been dealing with payors to approve these newer procedures for patients who would clearly benefit, not only in the treatment of their reflux symptoms from a quality of life perspective, but also to eliminate their need for ineffective medications with long-term side effects and costs—and to change the trajectory of this progressive disease state. A more accepting insurance environment would address this most critical need.
Dr. Shanu N. Kothari: Linx Reflux Management System for GERD
Dr. Kothari is Director of Minimally Invasive Bariatric Surgery, Gundersen Health System, La Crosse, WI.
Disclosures: Preceptor for TORAX
*Link to a recommendation for this article is below in Foregut Suggested Readings.
What can you tell us about the 1-year results you and colleagues reported on in an Annals of Surgery article this month regarding magnetic sphincter augmentation (MSA) with the LINX Reflux Management System for surgical treatment of gastroesophageal reflux disease (GERD)?
Dr. Kothari: In 2012, magnetic sphincter augmentation (LINX) was approved by the FDA. Part of this approval process involved continuing a post-approval study, the goal of which was to assess the outcomes in a broader clinical practice and not a subset of highly selected patients. This resulted in more “real world” outcomes and allowed us to see how the success rate compared to the original trial. In addition, 11 of the 17 participating centers in the post-approval trial were not in the original FDA trial. This resulted in recruitment of surgeons new to the device and in the early phase of incorporating this technology into their practice. The goal of the post-approval study was to demonstrate reproducibility of the technique with clinical outcomes that were superior to the wider variability often seen in Nissen fundoplication. Interestingly, 75% of the patients in this post-approval study had normalization of pH. This was higher than the original trial, probably because not every hiatal hernia was addressed or repaired in the original trial. We now know the importance of the “crural pinch” as part of the reflux barrier and the importance of crural approximation in addition to LINX implantation for optimal outcomes. In conclusion, 90% of the patients were off daily PPI therapy, over 90% of patients were satisfied with their clinical outcome, and over 75% had objective pH normalization.
How do you foresee this procedure improving treatment options and patient outcomes?
Dr. Kothari: There is a subset of patients that desires a surgical anti-reflux procedure but are not interested in the traditional Nissen fundoplication. They are aware of the side effects of the Nissen fundoplication, such as the inability to belch or vomit and postoperative gas-bloat syndrome. LINX has an efficacy equal to Nissen fundoplication but has the potential to diminish the frequency of the side effects, as the vast majority of patients are able to belch or vomit after LINX implantation. This results in a more favorable side effect profile that some patients find desirable.
As it relates to treatment options for patients, where will MSA fit within your current surgical armamentarium?
Dr. Kothari: Magnetic sphincter augmentation allows the foregut surgeon one more anti-reflux arrow in their quiver of treatment options based on their patients’ severity of disease, goals of treatment, and willingness to proceed with endoscopic versus surgical interventions. LINX, in addition to Nissen fundoplication, radiofrequency energy (Stretta), and transoral incisionless fundoplication (TIF) are all currently available options foregut surgeons have to offer patients presenting with disabling GERD. No intervention is perfect. Each procedure brings its own unique advantages, disadvantages, efficacy, and side effects. Adding LINX to this armamentarium allows surgeons another option to a subset of dissatisfied patients who are suffering from GERD and seeking freedom from chronic proton pump inhibitor (PPI) therapy.
What do you see as the most critical challenge foregut surgeons face today and why?
Dr. Kothari: Much like the field of bariatric surgery, the greatest challenge to foregut surgeons is that only about 1% of patients that qualify for surgical anti-reflux procedures undergo them. Reasons for this are multifactorial, including misinformation from providers who do not perform these procedures, patients uninformed that surgical treatments options are even available, and real versus perceived complications or side effects of the procedure that have tainted their desire to even consider surgery. The Internet and social media outlets are double-edged swords for patients seeking information regarding interventions available for GERD treatment. Surgeons with interest in disorders of the foregut remain the most qualified to provide informed consent of the currently available interventions.
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Suggested Readings
Bariatric
Article: The safety and efficacy of the procedureless intragastric balloon.
Alsabah S, Al Haddad E, Ekrouf S, Almulla A, Al-Subaie S, Al Kendari M. Surg Obes Relat Dis. 2018 Mar;14(3):311-317.
https://www.ncbi.nlm.nih.gov/pubmed/29305305
Dr. Jaime Ponce: This paper gives us clinical insight into a new concept in balloon therapy for obesity. It is a new innovative technology that allows placement of a fluid filled balloon without endoscopy—and potentially with no need for endoscopy in removal, as it gets excreted by itself.
Balloon therapy is not a perfect modality, but it enables obese patients to manage their obesity when the BMI is in between 30-40, when patients are not candidates for surgery, or when patients are not ready for surgery and have tried other weight loss methods without success. The experience reported here showed a 15% total body weight loss and small number of adverse events that still may need to be addressed in the management of this new technology.
Article: Effect of laparoscopic sleeve gastrectomy vs laparoscopic Roux-en-Y gastric bypass on weight loss in patients with morbid obesity. The SM-BOSS Randomized Clinical Trial. Ralph Peterli, MD; Bettina Karin Wölnerhanssen, MD; Thomas Peters, MD; et al. JAMA. 2018;319(3):255-265.
https://www.ncbi.nlm.nih.gov/pubmed/29340679
Dr. Dimitri Pournaras: This randomized controlled trial performed in Switzerland compared gastric bypass and sleeve gastrectomy. The five-year outcomes are reported demonstrating no difference in weight loss, which was the primary endpoint. GERD was more likely to go into remission after gastric bypass and to worsen or appear de novo after sleeve gastrectomy. There was no difference in quality of life and reoperations/reinterventions.
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Hernia
Article: Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial. Kaufmann R, Halm JA, Eker HH, et al. Lancet. 2018 Mar 3;391(10123):860-869.
https://www.ncbi.nlm.nih.gov/pubmed/29459021
Dr. Luke Funk: There is ongoing debate regarding the optimal method of umbilical hernia repair. This study is a multi-center, randomized controlled trial that examines whether mesh reduces umbilical hernia recurrence rates compared to a suture only repair. All umbilical hernias were 1 to 4cm in diameter. After more than two years of follow-up, the mesh group (n=150) experienced a hernia recurrence rate that was two-thirds lower than the suture only group (n=150): 4% vs. 12%, respectively. This study is important because it includes level-one evidence suggesting that mesh should be used for small umbilical hernias.
Article: A meta-analysis comparing open anterior component separation with posterior component separation and transversus abdominis release in the repair of midline ventral hernias. Hodgkinson JD, Leo CA, Maeda Y, Bassett P, Oke SM, Vaizey CJ, Warusavitarne J. Hernia. 2018 Mar 7. [Epub ahead of print]
https://www.ncbi.nlm.nih.gov/pubmed/29516294
Dr. Marina Kurian: This is an interesting study because we are doing more transversus abdominis release (TAR) than ever before and it would be good to know what our outcomes can be. From the current meta-analysis, we can establish that TAR is at the very least non-inferior to open anterior component separation. However, greater numbers are needed in both groups to really establish a clear benefit versus non-inferiority. We expect more studies to help delineate the benefit and patient-related outcomes for each approach.
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Foregut
Article: Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study. Louie BE, Smith CD, Smith CC, et al. Ann Surg. 2018 Apr 24. [Epub ahead of print]
https://www.ncbi.nlm.nih.gov/pubmed/29697454
Dr. Luke Funk: Nearly 10,000 magnetic sphincter augmentation devices (LINX) have been placed since they were approved by the FDA nearly 6 years ago. This study reports one-year results following LINX placement in a multi-institutional, prospectively studied cohort of patients in the US. Nearly three-fourths of patients had normal esophageal acid exposure at one year, while GERD symptoms were significantly better. Five out of 200 patients underwent device removal. More data are needed to understand if symptom improvement persists and device removal/complications remain low over a longer period of time.
Article: A Hill Gastropexy Combined with Nissen Fundoplication Appears Equivalent to a Collis-Nissen in the Management of Short Esophagus. Bellevue OC, Louie BE, Jutric Z, Farivar AS, Aye RW. J Gastrointest Surg. 2018 Mar;22(3):389-395.
https://www.ncbi.nlm.nih.gov/pubmed/28971337
Dr. Marina Kurian: This is an interesting article because it gives us an alternative to Collis-Nissen (C-N) in the patient with paraesophageal hernia and a shortened esophagus. Authors outline their success in symptom resolution and recurrence between Nissen Rossetti, C-N, and primary Nissen patients. This is a welcome addition to our literature and gives us options other than a C-N in these unusual but usual cases.
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Colon
Article: Elevated venous thromboembolism risk following colectomy for IBD is equal to those for colorectal cancer for ninety days after surgery. Ali F, Al-Kindi SG, Blank JJ, Peterson CY, Ludwig KA, Ridolfi TJ. Dis Colon Rectum 2018.61:375–381.
https://www.ncbi.nlm.nih.gov/pubmed/9420429
Dr. Sean Langenfeld: The current standard of care for patients undergoing open or laparoscopic colectomy for colon cancer includes 30 days of postoperative unfractionated or low molecular weight heparin at prophylactic doses. Most studies show that colectomy for inflammatory bowel disease is associated with an equal or higher risk of venous thromboembolism, and it is reasonable to consider extended prophylaxis in this group as well.
Article: Robotic versus laparoscopic right colectomy: an updated systematic review and meta-analysis. Solaini L, Bazzocchi F, Cavaliere D, Avanzolini A, Cucchetti A, Ercolani G. Surg Endosc 2018;32:1104–1110.
https://www.ncbi.nlm.nih.gov/pubmed/29218671
Dr. Sean Langenfeld: A robotic approach to right colectomy enables many surgeons to perform an intra-corporeal ileocolonic anastomosis (ICA) that they otherwise felt unable or unwilling to complete with conventional laparoscopy. A Pfannenstiel extraction site with ICA is associated with lower rates of incisional hernia compared to the midline incision typically employed for an extra-corporeal anastomosis (ECA). The literature for ICA is evolving, and it is possible that conclusions will appear different over time as surgeons ascend the learning curve for the newer technique.
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Introduction
This month’s issue features an interview with military surgeon Dr. Sayeed Ikramuddin, Interim Chair and Professor in the Department of Surgery at the University of Minnesota Medical School, who agreed to discuss his recently published JAMA study with MISS E-News. Dr. Ikramuddin has been at the forefront of research in weight loss surgery since we first worked together on relevant journal articles in 2004, and he has continued on that trajectory, becoming a critical contributor to clinical research in metabolic surgery and diabetes remission. I’d like to extend a very warm thank you to Dr. Ikramuddin for taking the time to share his insights and experience with us in this interview.
New this month, we also bring you the first of our video interviews from the 2018 MISS. In keeping with our topic of weight-loss surgery research, we present Dr. Daniel P. Schauer discussing his research on cancer reduction. Click here for our interview.
I hope you enjoy the interviews and this month’s article recommendations from thought leaders in minimally invasive surgery, brought to you by leaders at the forefront of research and innovation, who this month span a few different continents. Thank you to all of this month’s contributors!
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–Colleen Hutchinson
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Colleen: What are the key outcomes of your recent diabetes study?
Dr. Ikramuddin: We wanted to know if adding gastric bypass to intense lifestyle and medical therapy would improve overall diabetes treatment as represented by the triple endpoint of blood sugar, blood pressure, and cholesterol control. We found that adding gastric bypass did provide significant benefit at five years after surgery, but that the size of the benefit declined substantially from the first to the fifth year. We also found that gastric bypass did provide significantly better blood sugar control throughout the five years, but the rate of diabetes remission at five years was low. There were many more adverse events in the gastric bypass group.
Colleen: Who are the best candidates for surgery?
Dr. Ikramuddin: We need more research to find out which patients will respond best to surgery. This is an important question and one that is not answered by this study. There are multiple preoperative variables that might determine postoperative outcomes. Examples would include psychological status, beta cell reserve or insulin resistance, and even smoking status. How and why these factors—expanded to food intake and physical activity, and changes in microbiota—impact outcomes are not assessed in this study. More work needs to be done.
Colleen: When is the best time to intervene with surgery—early in the course of the disease or later?
Dr. Ikramuddin: We still don’t have solid evidence, but it is likely that earlier might be more effective, given the previous association of a higher C peptide (a marker of B-cell mass) and better control of metabolic endpoints—knowing that B cell mass actually is compromised with time.
Colleen: Do patients with a BMI less than 35 do as well as those with a BMI greater than 35?
Dr. Ikramuddin: Based on our experience and a limited other set of data, it looks like the BMI of less than 35 group responds as well as those with BMI over 35.
Colleen: How will your study change the management of type 2 diabetes?
Dr. Ikramuddin: Whether the gastric bypass surgery is an appropriate treatment for diabetes is a matter of perspective. The improvement in achievement of triple endpoints is significant but may not be large enough to warrant the adverse events. The surgery group did get better blood sugar control at the price of more adverse events.
Colleen: How would you characterize the evolution of and advances in research surrounding diabetes and weight loss surgery since you began in this field?
Dr. Ikramuddin: I began bariatric surgery in 1998. At this point the open gastric bypass was the main procedure being performed, with three groups pushing the frontier of minimally invasive surgery. Despite a paper just a few years earlier calling out the benefits of surgery for diabetes, most of the work focused on establishing the of role minimally invasive techniques and prospective uncontrolled enrollment and assessment of outcomes. The impact of the gastric bypass on ghrelin, the hunger hormone, the observations of postprandial gastric bypass hypoglycemia, and the promise of “cure of diabetes” propelled the field forward.
Interest from endocrinologists, gastroenterologists and basic scientists has allowed for careful assessment of the effect on tissue-specific insulin action following surgery—though clear differences from weight loss have not emerged in humans. The plethora of small animal models with loss and gain of gene function, the use of metabolomics, and tissue-specific transcriptomic and proteomics bring us closer to understanding fundamental pathways separating weight loss and surgery.
The role of the microbiome as causal or casual to these metabolic changes is well underway, with interventional studies planned to salvage cases of surgical failure. Just as the sleeve was gaining and the band was losing popularity, randomized studies were initiated that focused on glycemic or metabolic syndrome control in patients with BMI’s lower than traditionally used as indications for surgery. After the gastric bypass and sleeve gastrectomy, patients with poorly controlled diabetes achieve treatment goals more robustly, lose some effect over time, and have more adverse effects than medical management independent of BMI.
The distraction of a “cure” for many was replaced by the observation of durable significant weight loss and potentially a reduction in diabetes and all-cause mortality—something not yet seen with lifestyle intervention alone and reductions in cardiovascular disease mortality just recently observed with pharmaceuticals in patients with type 2 diabetes. Thus the impact of bariatric surgery on adipose tissue inflammation – a fertile ground for cancer – remains an active area of study.
Multiple randomized trials comparing the sleeve and the gastric bypass have completed enrollment. The lower risk-benefit of the sleeve gastrectomy has made it the most popular procedure, while we still have not fully grasped its metabolic differences compared to the gastric bypass. Carefully performed large animal studies will likely add insight. In the interim, what is still missing is a large-scale, long-term study of the sleeve gastrectomy with a primary endpoint of mortality in patients with a BMI more than 35 kg/m2 compared to lifestyle intervention and best medical management.
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Suggested Readings
Colon
Article: Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial.
Rullier E, Rouanet P, Tuech JJ, Valverde A, et al. Lancet. 2017 Jul 29;390(10093):469-479. doi: 10.1016/S0140-6736(17)31056-5. Epub 2017 Jun 7.
https://www.ncbi.nlm.nih.gov/pubmed/28601342
Dr. Rodrigo Perez: The possibility of organ preservation in patients with rectal cancer has become an attractive option in patients with good response to neoadjuvant chemoradiation (nCRT) to avoid significant morbidity and functional consequences of radical proctectomy with total mesorectal excision (TME). In the present study, patients with excellent response to nCRT were randomized to local excision or radical surgery with TME. Even though in an intention to treat analysis, there were no differences in a composite outcome (including local recurrence or significant postoperative complications), patients that required “completion” TME due to the risk of residual mesorectal disease developed significantly worse functional outcomes. Patients achieving apparent good response to nCRT and underwent local excision + TME were also at higher risk for the requirement of a definitive stoma.
Article: Quality of local excision for rectal neoplasms using transanal endoscopic microsurgery versus transanal minimally invasive surgery: a multi-institutional matched analysis. Lee L, Edwards K, Hunter IA, Hartley JE, Atallah SB, Albert MR, Hill J, Monson JR. Dis Colon Rectum. 2017 Sep;60(9):928-935.
https://www.ncbi.nlm.nih.gov/pubmed/28796731
Dr. Steven Wexner: As more platforms have been introduced to allow surgeons to employ this technology, the question has of course arisen as to whether or not there is any preference in the results obtainable based upon the platform used. In one prior article I wrote, I noted that both the flexible and rigid product lines have roles in this therapy. Most recently, Lee and colleagues performed a cohort-matched analysis of 247 patients who underwent TEM with 181 patients who underwent TAMIS. Although the TAMIS approach was associated with a slightly shorter operative time, unfortunately the TAMIS procedures were performed at one facility, whereas the TEM procedures were performed at two other facilities. Therefore, potentially the speed of the surgeon rather than the speed afforded by the instrumentation may have accounted for this finding. However, although the speed of the surgeons may have differed, the skill certainly did not: poor quality excision was similar at 8% versus 11%; peritoneal violation was identical in 3% in each group; and postoperative complications were markedly similar at 11% and 9%, respectively. Very importantly, five-year disease-free survival rates were virtually identical at 80% five years after TEM and 78% five years after TAMIS. Lastly, there was a 7% incidence of local recurrence in patients who had undergone surgery for malignancy in each of the two groups. Therefore, the authors concluded that within the realm of TES, TAMIS and TEM offer virtually identical outcomes. The choice of platform can safely be left to the discretion of the surgeon.
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Foregut
Article: Comparison of one stage laparoscopic cholecystectomy combined with intra-operative endoscopic sphincterotomy versus two-stage pre-operative endoscopic sphincterotomy followed by laparoscopic cholecystectomy for the management of pre-operatively diagnosed patients with common bile duct stones: a meta-analysis. Tan C, Ocampo O, Ong R, et al. Surg Endosc (2018) 32: 770.
https://www.ncbi.nlm.nih.gov/pubmed/28733744
Dr. Cory Richardson: This meta-analysis compares outcomes of laparoscopic cholecystectomy with intraoperative endoscopic retrograde cholangiopancreatography (ERCP) to preoperative ERCP followed by laparoscopic cholecystectomy. An analysis of five randomized controlled trials revealed an equal success rate of common bile duct (CBD) clearance (intraoperative = 93%, preoperative = 92%). Additionally, intraoperative ERCP compared to preoperative ERCP was associated with significantly less pancreatitis (0.6% vs 4.4%), lower overall morbidity (6% vs 11%), and shorter hospital stay (3.52 vs 6.10 days). The results of these studies (in addition to studies showing improved outcomes with laparoscopic cholecystectomy [LC] + laparoscopic common duct exploration [LCDE]) should continue to push us toward treating this disease process in a single operation. One of the biggest hurdles in accomplishing this is coordinating multiple specialties/teams, which can be overcome with further efforts to train more surgeons to perform ERCP (as well as LCDE).
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Hernia
Article: Critical under-reporting of hernia mesh properties and development of a novel package label. Kahan LG, Blatnik JA. J Am Coll Surg. 2018 Feb;226(2):117-125.
https://www.ncbi.nlm.nih.gov/pubmed/29133265
Dr. Ajita Prabhu: This is an article focusing on the lack of useful packaging information associated with mesh devices for hernia repair. This is the first article of its type to point out that surgeons really often don’t have access to relevant information for these devices, and yet we are still obviously responsible for our own outcomes. It’s an important part of being a surgeon to know what you are using and why. I think the concept of a standardized label, akin to nutritional information, is novel and clever. But importantly, this article reviews the amount of information available in several accessible devices, and shows that we have a long way to go with this. This is a topic that is not going away (in fact it is often in the news for lawsuits, etc), so we need to be able to educate ourselves on this.
Article: A call for standardization of wound events reporting following ventral hernia repair. Haskins IN, Horne CM, Krpata DM, et al. Hernia. 2018 Feb 10. [Epub ahead of print]
www.ncbi.nlm.nih.gov/pubmed/29429064
Dr. Ajita Prabhu: This is an article reviewing the lack of standardization of nomenclature of wound events after hernia repair. This matters because if there aren’t clearly defined criteria and descriptors for complications after surgery, it really makes it very difficult to assess our outcomes and therefore our opportunities for improvement. Other disease processes have this ironed out, with pancreatic cancer being a great example. It’s important for us to determine what counts as a wound event, what to call it, and how to follow it so that we can talk to each other in a common language about how our patients are doing and how better to care for them.
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Endoscopy
Article: Impedance-pH monitoring on medications does not reliably confirm the presence of gastroesophageal reflux disease in patients referred for antireflux surgery. Ward MA Dunst CM, Teitelbaum EN, et al. Surg Endosc (2018);32:889.
https://www.ncbi.nlm.nih.gov/pubmed/28779252
Dr. Cory Richardson: Many patients who continue to have reflux symptoms despite being on antireflux medication undergo impedance-pH testing while on medication. Some of these patients then get referred for surgery because of “refractory reflux” despite optimal acid suppression. The authors retrospectively reviewed patients who were referred for persistent reflux symptoms despite pH-confirmed adequate acid suppression. They then performed Bravo-pH studies off medication on these patients and compared the results with their original impedance-pH studies. Bravo-pH testing was abnormal in 84% of patients with abnormal impedance-pH testing and in 67% of patients with normal impedance-pH testing. The authors concluded that impedance-pH testing on medication does not reliably confirm the presence of GERD. Because achieving excellent outcomes with antireflux surgery requires an accurate diagnosis of GERD, the authors recommend pH testing off medications prior to offering antireflux surgery.
Bariatric
Article: Individualized metabolic surgery score: procedure selection based on diabetes severity. Aminian A, Brethauer SA, Andalib A, et al. Ann Surg. 2017 Oct;266(4):650-657.
https://www.ncbi.nlm.nih.gov/pubmed/28742680
Dr. Ricardo Cohen: This scoring system is based on some well-known preoperative predictive factors of type 2 diabetes (T2D). Four independent predictors of long-term remission, including preoperative duration of T2D, preoperative number of diabetes medications, insulin use, and glycemic control (HbA1C < 7%), were used to develop the Individualized Metabolic Surgery (IMS) score using a nomogram.
Although validated through two different high volume bariatric surgery centers, the sleeve gastrectomy, according to the authors, may be suggested only to those patients where the benefits of any therapy, including surgery, will not deliver actual benefits, mainly if the endpoint is to put T2D under full control.
Article: Portomesenteric and splenic vein thrombosis (PMSVT) after bariatric surgery: a systematic review of 110 patients. Shoar S, Saber AA, Rubenstein R, et al. Surg Obes Relat Dis. 2018 Jan;14(1):47-59.
https://www.ncbi.nlm.nih.gov/pubmed/29111221
Dr. Michael Schweitzer: Venous thromboembolism after bariatric surgery includes portomesenteric and splenic vein thrombosis (PMSVT), which is rare and was estimated by this study at 0.4%. Of the 110 patients who developed PMSVT, 35.4% were on oral contraception, 61.1% had previous surgery, 37.2% had a history of smoking, and 43% had a history of coagulopathy. 78.9% had PMSVT occur after laparoscopic sleeve gastrectomy versus other types of bariatric surgery, and 88.9% occurred in the first month. This important systematic review does not address timing of chemoprophylaxis, extended chemoprophylaxis, operative times, and other possible factors that may alleviate or contribute to PMSVT.
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