The American Society for Metabolic and Bariatric Surgery (ASMBS) is the largest national non-profit medical organization devoted to metabolic and bariatric surgery, in addition to obesity-related diseases and conditions. The society was established in 1983 with a vision to “improve public health and well being by lessening the burden of the disease of obesity and related diseases throughout the world”. Its main mission is to enhance the quality of care of the patients suffering from obesity. One of the means to achieve this objective is through “advocating for the healthcare policy that ensures patient access to high quality prevention and treatment of obesity”.
In accordance with its mission, ASMBS recently released an Endorsed Procedure Table (see below). As per Professor Eric J DeMaria, the current ASMBS president, this table was issued as part of updating the standards for MBSAQIP accreditation currently in process. Although the list was welcomed by many surgeons across the nation, it raised several questions by prominent bariatric US surgeons.
Professor DeMaria answered many of these inquiries by releasing a presidential letter to the ASMBS members. In addition, and to clear any remaining confusion, he granted the IBC Newsletter an interview to address some of these concerns.
1. The ASMBS recently updated the ASMBS Endorsed Procedure List. Why an update at this time? And how is this list different from the previous one?
The table of ASMBS Endorsed Procedures was re-formatted as part of updating the standards for MBSAQIP accreditation currently in process by ASMBS working together with the American College of Surgeons. Most notably, changes in the Endorsed Procedures Table were made to resolve confusion about when Institutional Review Board (IRB) approval or exemption was required, not in the list of endorsed procedures itself. Some individuals have misinterpreted the Table, leading us to publish a further clarification. As an example of the issues with interpretation, some individuals who pulled up the Table on their mobile phones did not visualize the entire table, therefore leading them to believe that all procedures listed were now “endorsed” by ASMBS. This is untrue and in fact we have not added any new procedures to the endorsed list since ASMBS endorsed the intra-gastric balloon procedure several years ago.
2. We noted in the updated list that the ASMBS still endorses procedures (example VBG) that have limited current use as these procedures lack good longer term outcomes and are associated with higher risk of complications. Is there a plan to remove such procedures off the list in the future? And why were these procedures not removed in this current update?
The VBG procedure has not been re-reviewed at this time but there has been active discussion about doing so. The ASMBS process for procedure review is robust and comprehensive and some of our review committee members feel that expending so much effort on review of a procedure that is rarely utilized today would represent a substantial effort with little to gain, and that instead we should keep our efforts focused on reviewing the growing number of new emerging procedures. In addition, others have expressed that, since we are battling an epidemic disease, we should keep all available tools to treat the disease available to our members and allow them the discretion to use these tools as they judge appropriate. This is essentially a philosophical discussion as all committee members feel that the VBG has essentially become irrelevant over time due to various factors.
3. The Intragastric Balloon, Aspire device and vBLOC were endorsed and are IRB exempted while more efficacious procedures still need IRB approval. Is this an industry driven decision? Does the ASMBS have the ability to drop a device off the endorsement list although FDA approved that specific device?
This is factually incorrect and resulted from misinterpretation of the Endorsed Procedures Table. The Aspire device and the vBLOC procedures are FDA approved and therefore do not require oversight by an IRB in order to perform these procedures, however they are not endorsed by ASMBS. In fact, ASMBS has not reviewed these procedures for endorsement as of the current time and, in fact, has not received a request from our membership to conduct a review, as required by our process. Of these, only the intragastric balloon has been reviewed and endorsed by ASMBS via our standard process. ASMBS does have the ability to remove its endorsement from a device or procedure even if it were to remain approved by the FDA, as the two processes are independent of one another. On another note, industry has NO ROLE in the evaluation of procedures for endorsement by ASMBS. Industry does notparticipate in the process and there are no industry representatives at the table for discussion at any point along the pathway for new procedure endorsement by ASMBS.
4. Is there a reason behind the difference in positions between IFSO and ASMBS regarding OAGB/MGB and SADI? There is level 1 data especially for the OAGB/MGB coming from very prominent and experienced worldwide academic centers. Why does the ASMBS need US data to endorse a specific procedure and not use international data for that matter?
To date, ASMBS has not endorsed the OAGB procedure nor the SADI procedure, although the SADI procedure is being re-reviewed this year as the previous review was 3 years ago. ASMBS does not require U.S. data to favorably review a procedure for endorsement. At the time of the most recent review of OAGB, members of the decision-making committee did not vote to support endorsement and expressed persistent concerns about the potential impact of endorsing this procedure in the United States. Concerns expressed included the potential impact on long-term patient care due to the malabsorptive nature of the procedure as well as persistent concerns about the issue of bile reflux.
5. In regards to IRB, is there any plan from the ASMBS to lead multi-institutional prospective trials to study procedures as SADI and OAGB/MGB? Would that have more impact than smaller studies coming from smaller hospitals or surgical centers using their own IRB process?
Although the concept of creating an IRB process for ASMBS members to use in order to perform and study certain selected new procedures and report their outcomes via MBSAQIP, this would be a complex undertaking. As of today, there has been no agreement on a plan to do this.
6. Some of the members performing the OAGB/MGB and SADI feel that this list exposes them in front of the medicolegal system if they run into ‘’normal’ or “expected” post-operative complications. To add, this newer list may give insurance companies an excuse to deny these procedures. Are the members’ concerns justified?
These procedures are not endorsed by ASMBS and, as these are procedures and not devices, they are also not covered by FDA in terms of approval. Therefore, at the current time, MBSAQIP requires IRB oversight or a letter from the IRB noting an exemption in order for accredited centers to perform these procedures. Although not complete protection, the detailed informed consent process required by most IRB’s should help protect members performing these procedures from at least some of the potential liability involved. As the procedures are not endorsed by ASMBS, the society has not advocated for insurance payers to approve these procedures.
7. How often does the ASMBS Endorsed Procedure List gets updated? And when is the next expected update?
The list is updated each time a procedure is added or removed. There is no regular update schedule, but ASMBS is utilizing our new procedure endorsement process to evaluate new emerging procedures for inclusion each year.
Credit to ASMBS
Eric J DeMaria
Professor and Chief
General and Bariatric Surgery
Brody School of Medicine at East Carolina University
Eric J DeMaria ASMBS President
After the very successful IBC Oxford World Congress 2019, IBC Newsletter met with Dr. Haris Khwaja and had this interview to discuss the conference as well as to highlight on some of the main events in that fruitful meeting.
1- There exists several bariatric meetings worldwide sponsored by traditional bariatric societies including IFSO and ASMBS, why did IBC need to have its own meeting?
There are several reasons behind why the IBC started its own congress. Firstly, the interest in the IBC and the IBC symposia was growing rapidly since the inaugural IBC symposium in 2011 at IFSO Hamburg which was at the kind invitation of Professor Rudolf Weiner. The IBC had organized 25 satellite symposia before the first IBC Oxford World Congress in March 2018 and was well respected as an unbiased, educational platform that promoted lively and controversial debates, discussion and analysis via digital and live surgical meetings. Many high profile bariatric surgeons were also suggesting for many years that IBC needs to have its own congress but to be honest I never thought it would be possible. IBC indeed had a yearly successful symposium at IFSO from 2011 to 2015 and we were all very honored and excited by this opportunity so I never saw the reason to set up our own congress as it is a mammoth task. Unfortunately after the hugely successful IBC symposium at IFSO Vienna in 2015 and for complex reasons related to ‘control’ of the IBC which I will not go into detail there was no IBC symposium the subsequent year at IFSO Rio in 2016. This event was the real catalyst for the establishment for the first IBC Oxford World Congress. It was fortuitous that during the same week I received notice there will be no IBC symposium at IFSO Rio I had my 15 year reunion at Oxford University. During that reunion the Dean of Christ Church, University of Oxford was excited to learn of the work I had been doing with my colleagues with respect to the IBC given the fact Oxford University is a global educational powerhouse. Following this discussion at my reunion, Oxford University reached out to assist in the inaugural IBC Oxford University Congress and I also contacted my good friend, Mr. Bruno Sgromo based at the John Radcliffe Hospital in Oxford to assist me in this endeavor. That was exactly how the first meeting was set up.
So Omar it was the combination of the support of eminent bariatric surgeons, the demand of such a congress from at that time the 4500 IBC members, the unfortunate concurrent issue with IFSO and the offer from Christ Church, University of Oxford which combined to give birth to the IBC Oxford World Congress.
I would like to add however that I am delighted the IBC has been invited this year to IFSO Madrid by Professor Antonio Torres and Professor Almino Ramos and I am very grateful to Professor Natan Zundel for his warm invitation to IFSO Miami in 2020. This is a great honor for the IBC after being absent from IFSO since 2016.
2- How many delegates were present and how many countries were represented in the 2018 meeting and how many in the 2019 meeting?
The first congress at Christ Church, University of Oxford was deliberately a small meeting with 140 delegates from 39 countries. The second congress a few weeks ago which was at the University of Oxford Examination Schools had 217 delegates from 55 countries. The target was actually 200 delegates and the registration was closed 5 weeks before the meeting started but due to demand, the registration period was temporarily extended. My aim is to keep the meeting small so it would be easy to manage as my colleagues and I do all the organization ourselves as we do not employ a conference management company. In fact I design all the large banners myself as I have an interest in graphic design, Namal Rupasinghe and Tomasz Rogula design the website, Ariel Ortiz and his team look after IBC TV and Manoel Galvao Neto keeps us abreast of endoscopic innovations. As a club, we do not want to lose the critical interactions between the different speakers and delegates during the academic program, coffee breaks, lunches and dinners. My key priority with this meeting and all IBC symposia has been ‘quality’ and I listen attentively to every lecture, debate and panel discussion. The quality issue extends to not just the academic program but also to the quality of the lunches and dinners that indeed I spend many months organizing with the catering team at the congress venue and Christ Church where the dinners are held. Christ Church Hall seems a fitting venue for congress dinners given its’ beauty and history and the feedback has been very positive. It may be in the future we would need to move the dinners to a different venue given the fact Christ Church Hall can only accommodate 320 delegates for dinner.
3- How are the topics at IBC Congress different from the topics at the other bariatric conferences? How were you able to avoid repetition?
We were well aware that there is a lot of repetition at national and international congresses, not just repetition of topics but also of speakers. We were also aware that there are a lot of talented surgeons in the world who perhaps don’t get the exposure they deserve on a national or international stage for a multitude of reasons. The great thing about the IBC Facebook page is that you get to see thousands of bariatric healthcare professional upload their interesting cases, complication, technical pearls and one can read the subsequent discussions. This allows us to identify very easily emerging talent as well as established leaders with a view to offering those bariatric healthcare professionals an opportunity to take part in the congress in Oxford University. As for the topics, we always strive to be original and fresh. We also think outside the box by looking at the current controversies and expanding on them with no concern about going against the status quo. A good example was the poll on IBC Facebook page regarding the informed consent for sleeve gastrectomy. Two hundred surgeons answered that poll. Two thirds of surgeons would not mention the risk of Barretts esophagus to their patients during the consent process. This poll was translated into a great panel discussion at the 2019 Oxford meeting. Another example of an area IBC will be exploring at forthcoming meetings are bariatric surgery registries and who should enter the data into the registry, the surgeon (or his/her team) or an independent data administrator. This will indeed be a key debate at the 29thIBC Symposium at IFSO Madrid. Our main focus is on quality and to give a stage to well respected as well as talented younger surgeons
4- IFSO seems to be embracing IBC again. Is it Prof. Almino Ramos who is leading this change or it is a decision from IFSO as an organization?
I do not know the reason for the change but Professor Ramos has certainly built bridges during his time as IFSO President. For me he has been a mentor and someone who I have followed for many years. I first met him in 2012 at IFSO Istanbul on the coach trip to the Gala Dinner. I was amazed how friendly and sincere he was and how he talked to me with respect even though I was a young surgeon just out of fellowship. Similarly Professor Antonio Torres has been a great supporter to IBC for years and has taken part in so many IBC symposia despite his busy schedule. He has always been kind to IBC.
I do believe the presence of IBC at IFSO is great news for both organizations. I would like to say I am also grateful to many of the national bariatric surgery societies/meetings who have also supported IBC symposia. We all thoroughly enjoy setting up these meetings.
5- There is IBC Facebook Group, IBC Congress, IBC Webinars, IBC Symposia IBC TV and now IBC Newsletter? What is next? Don’t you feel that this newer platform that social media is offering, worries the traditional societies?
I have never worried what other organizations think of the IBC. We all learn from each other and I have attended a lot of non-IBC meetings which were super high quality. That said, those different educational branches you mention (IBC TV, Webinars, Meetings) are very easy for us to do as we have been doing them for years.
I believe education has moved on a lot over the past 10 years. In the past it was text books, traditional paper journals, and then online journals but now due to our time constraints we learn through digital and social media platforms and online journal clubs. We all complement each other and all organizations offer something different but of equally high quality.
6- What was the best debate in the 2019 Congress?
All the debates were excellent this year. The debate between Helmuth Billy and Bhandari Mohit on Banded Sleeve gastrectomy - ‘Surgical Genius or Regressive Innovation’ was great and I learned a lot from both speakers through their evidence based arguments. Both were very articulate and well prepared. In 2019 all the debates were super high quality and I have to thank Dr. Edward Felix and Professor Carlos Vaz for their debate on robotics in bariatric surgery, Professor Safwan Taha and Professor Almino Ramos for their debate on Endoscopic Vs. Surgical Revision of the gastrojejunostomy post-gastric bypass, Professor David Kerrigan and Professor George Fielding for their debate on gastric banding for morbidly obese type 2 diabetic patents, Professor Richard Peterson and Professor Khaled Gawdat for their debate on the ideal gastric pouch in RYGB and Professor Jean Marc Chevallier and Professor Enrique Elli on MGB/OAGB Vs. LRYGB. All debaters were well prepared, provided strong evidence based arguments and debated with good humor.
7- Is it true that Helmuth Billy is a gifted debater?
Without doubt, Helmuth is a very skilled debater. He contacted me 2 months before the congress and asked about the debate format. My answer was that each debater has 8 minutes, no swearing or personal insults allowed (after what happened with a different debater in 2018) and that slides were optional. I explained when I was a student at Oxford many years ago, debates were and are still done without slides, as all the arguments are in the head of the debater so you are able to get more information out to the audience during the allocated time. He did just that and I must say it takes a lot of courage to do that. He is very gifted not just as a debater but also as a speaker and a surgeon. In fact he gave a fantastic lecture about the use of ICG in bariatric surgery with great slides and embedded videos.
8- What about the Dalai Lama letter and Professor Sir Cuschieri’s key note speech?
It was very nice and humbling to receive a letter of support from His Holiness The Dalai Lama a few days before the meeting. We are very grateful to Professor Pradeep Chowbey who presented that letter to the delegates on behalf of the His Holiness at the congress. We all know that the His Holiness is globally very well respected and has an interest in global health so we really appreciated his letter of support.
We were also honored by Professor Sir Alfred Cuschieri’s presence at IBC Oxford 2019. He has a very busy schedule and works between Edinburgh, Scotland and Pisa, Italy. He gave a great talk regarding the history and future of laparoscopic surgery. We are very grateful to all the delegates and speakers who came to this meeting and contributed. It was a high quality meeting and I have bigger plans for 2020. We have moved the congress in 2020 to the University of Oxford Mathematical Institute, a futuristic state-of-the-art congress venue which has seen many of the sharpest minds in the world lecture, debate and argue. The dates are April 6-7, 2020 and dinner on both days will be in the Great Hall at Christ Church, University of Oxford.
Dr. Haris Khwaja
Co-founder International Bariatric Club
Director of International Bariatric Club Global Education
Dr. Haris Khwaja
This section highlights a debate between Dr. Daniel Cottam (Director of the Bariatric Medicine Institute, Utah, USA) and Dr. Tarek Waked (Director of Bariatric Surgery at Nanticoke Memorial Hospital, Delaware, USA). Dr. Cottam will be representing Single Anastomosis DuodenoIleal Bypass (SADI) and Dr. Waked the Biliopancreatic Diversion with Duodenal Switch (BPD/DS). The expert opinion is by Dr. Rana Pullatt (Professor of Surgery at Medical University of South Carolina, South Carolina, USA) with the chief resident Benjamin White from the same program.
1. When do you offer SADI to your patients? Any specific BMI? Age? Comorbidites?
Our group has published several articles on predicting Sleeve success pre-operatively and post operatively. Basically, we have found that Sleeve patients fail at an 80% rate with a BMI of 53 or a BMI of 43 with T2DM. So we don’t like to be near those numbers because we believe an 80% failure rate is unacceptable. Therefore, any patient with a BMI of 50 or greater, or any patient with T2DM gets a discussion about SADI. We have no age restriction for this procedure and have done several patients over 80 with good success.
2. What bougie size do you use? What limb lengths? Do you alter your procedure according to age, BMI or length of bowel of your patient?
We use a 40 French bougie in our practice and I recommend not going smaller than that as too much restriction gets patients into trouble with lots of malabsorption. Our results are similar to Dr. Torres in Spain and he uses a 56.
Our standard limb length is 300 cm from the ileocecal valve. However, I will lengthen that if the patient has a lower BMI or if they have lots of muscle mass. This is based on lots of research from bypass and DS papers on total limb length for weight loss and Dr. Torres on revision rates. We wanted to have revision rates of 1% or less for malnutrition or diarrhea and this limb length achieves that while sacrificing very little in the way of excess weight loss.
3. What is the expected long-term weight loss? What about resolution of comorbidities?
There have been many papers published on this and when the total alimentary limb lengths are equal the Roux en Y DS has similar weight loss to the SADI. At 4 years we see 88% EWL. This is exactly the same as Marceau’s data out of Montreal with a RYDS at similar time points, similar patients and similar total alimentary limb lengths.
Our 4-year T2 DM data shows 89% EWL at 4 years. These results have been replicated in over 5 centers around the world so they are very solid. This is over double the RYGBP rate.
4. What are the potential long-term complications and what incidence do you see in your current practice?
When we stopped doing Roux limbs in our practice we showed a 350% drop in overall complications (this includes minor and major). Post-operative EGD’s went from 20% to <1. Ulcers went from 5% to 0. Severe diarrhea stopped as did our copper and zinc problems. In 5 years and 1000 cases there have been no internal hernias.
This is not to say there are no problems. With 300cm common channel you will still get around .5% of patients who develop diarrhea that is uncontrollable post operatively and need a revision to a longer channel. Also, we have finally had a first malnutrition patient who required TPN prior to a limb lengthening revision. Additionally, I detailed a unique cause of nausea when food goes down afferent limb and stays there. Nausea starts when the small bowel dilates approximately five minutes after eating.
This has to be contrasted with Roux limb long term complications. Internal hernias(1% per year) and perforations (1% per cohort) happen anytime day or night sometimes with no warning. SADI complication on the other hand happen but they come in to your office and can be handled easily and worked up.
5. Why SADI versus traditional DS? What are the advantages of SADI and disadvantages of DS?
The big misinformation that all practitioners of Roux limb bariatric surgery maintain that they have found the secret to low internal hernia rates. Yet, none ever publish their data. There are now 5 long term papers showing 1% per year rate of internal hernias with no change in the incidence through time. SADI on the other hand has no incidence of internal hernias.
Also, the lowest rate of ulcers ever reported for roux limb approaches is 2%. Most papers it is in the 5% range. SADI has a 0.15% incidence of ulcer formation and no perforations. That means at minimum the ulcer rate is 13 time higher for Roux limb approaches.
In our mind it is unacceptable to perform a Roux limb based bariatric surgery unless there are extenuating circumstances as the complication rates are just too high for this approach (I know this sounds extreme but the numbers don’t lie).
6. Do you believe that SADI is appropriate as a revisional procedure (Sleeve to SADI or RYGB to SADI)? What percent excess weight loss should a patient expect in a revisional case to SADI?
This is interesting since I have been asked to speak many times on this in the recent past and we currently have a paper under review right now with 100 patients. The weight loss for sleeve to SADI is very good with 70% EWL at 2 years. We also find patient do just as patients who have SADI as a primary surgery. This lets us in many instances stage difficult patients or delay the DS portion of the surgery.
Perhaps the most amazing thing is that when you just do a DS patient have very little nausea and pain. We now perform this as an outpatient surgery. This fact is revolutionary. We have taken the most common failure (sleeve failure) and can perform a revision procedure (DS only) and not only can we send them home the same day but they can do as well as a primary patient. No longer does revisional surgery have to be scary with high complications. And it has better long term weight loss than Sleeve to GBP.
7. DS is composed of 3 parts a) Sleeve b) Duodenoilesotomy c) Ileoileostomy. Do you believe with SADI and you are only doing 2 out of the 3 steps and thus an incomplete procedure?
The traditional DS is called a biliopancreatic diversion with duodenal switch. All we are doing is eliminating the biliopancreatic diversion, we are still doing the duodenal switch. While this is a small change it has not altered the weight loss and has reduced the complication rate by huge amounts. History, has shown that progress is made by small steps not giant leaps. This is a small modification that has huge implications.
8. Have you converted a SADI to DS due to insufficient weight loss?
We have tried this on one patient and it did not work. In retrospect shortening the amount of intestine from 300 all common channel to 150 common channel and 150 roux limb only gets the patients marginal malabsorption benefits. At most this would be 20 to 30 fat only calories a day over what they did have. This is simply not how this surgery works. For reasons that are still unclear the DS allows fat cells to metabolize fat stores and use them for daily energy. I like to say that the DS is a fat cell metabolic procedure and not a malabsorption procedure (unless your referring to vitamin uptake) and therefore adding more malabsorption will not work.
1. When do you offer BPD/DS to your patients? Any specific BMI? Age? Comorbidites?
In my practice, BPD/DS is offered as a primary bariatric procedure for patients with a BMI >50 or as a revisional procedure for patients with BMI >40. However, there is limited data with similar malnutrition outcomes in patients with BMI 40-50. It is important to add patient’s weight loss expectations to the selection criteria since some patients are not comfortable with losing 70-90 % EWL. Age limit in my current practice is 18-50. Comorbidities, especially type 2 diabetes mellitus and hyperlipidemia play a role in patient selection, but the most important factors include compliance, ability to afford vitamins and frequent postoperative tests, absence of Barrett’s esophagus, absence of osteoporosis or nephrolithiasis. Although rare, patients with known malrotation of the gut may also be good candidates for BPD/DS because the small bowel lays on the patients’ right side and a duodenoileostomy created in the right upper quadrant places less stretch on the mesentery of the alimentary limb.
2. What bougie size do you use? What limb lengths? Do you alter your procedure according to age, BMI or length of bowel of your patient?
I have adopted a common channel of 125 cm with an alimentary limb of 150 cm. These measurements are constant for all patients irrespective of their BMI, age, primary or revisional procedure, or length of bowel. Sleeve is made to accommodate a 50 F Bougie.
3. What is the expected long term weight loss? What about resolution of comorbidities?
Expected weight loss for BPD/DS ranges 70-90% EWL 4,5. At least 90% of patients with type 2 diabetes cease diabetic medications by 12 to 36 months. Between 50% and 80% of hypertensive patients are cured, with another 10% experiencing improvement. Up to 98% of patients with obstructive sleep apnea experience resolution 3.
4. What are the potential long term complications and what incidence do you see in your current practice?
Potential long-term complication risk for BPD/DS varies in the literature. These include anastomotic stricture/ulcer (<5%), internal hernia (up to 7%), bowel obstruction, vitamin and protein deficiency (2-7%).
5. Why traditional DS versus SADI? What are the advantages of DS and disadvantages of SADI?
Advantages of traditional DS over SADI-S:
i. Potential higher leak rates for SADI-S or any DS loop configuration. This may be attributed to activated pancreatic enzymes and bile flowing past the duodenoileal anastomosis 1
ii. Duodenoileostomy leaks are more severe with SADI-S due to lack of bile/pancreatic fluid diversion.
iii. Duodenoileostomy leaks are not amenable to endoscopic covered stent placement due to loop configuration. Covered stents will obstruct the biliary-pancreatic limb.
iv. Although very rare, single anastomosis DS may still result in bile reflux as opposed to traditional DS.
b. Expected weight loss and long-term weight regain
i. No long-term literature to support equivalency or superiority of SADI-S over DS. Except for 1 study with 5-year data in 100 SADI-S patients7, follow-up remains limited to 1 year for most of the publications. Most DS long term literature quote 70-90% EWL.
ii. The common channel length affects overall weight loss, particularly in patients with BMI >=50. Several authors report significantly less weight loss in patients with longer (250 or 300 cm) common channels of SADI-S compared to the 100 or 150 cm in DS, even when employing equivalent total alimentary limb lengths8,10. This potentially reflects the additive impact of greater fat calorie absorption that accompanies the SADI-S longer common channel.
iii. Pathophysiological studies comparing DS and SADI-S: breath test for fat malabsorption showed pathological results in 77.78% of patients of DS and 60% of SADI-S after 3 months. At 12 months, these pathological results were found in 85.7% of DS patients, but no SADI-S patients had fat malabsorption. Biliary salts malabsorption was found in 10% of patients of DS after 3 months, and in 14.3% after 12 months. None SADI-S patients had biliary salts malabsorption at any point of follow up. Are SADI-S patients experiencing bowel adaptation? If so, may this result in long term weight regain when compared to traditional DS? 2.
iv. No studies to date addressing long term ineffective weight loss or weight regain after SADI-S. Hess and Marceau showed only a 0.5-2.7% revision rate for inadequate weight loss for BPD/DS 6. One may infer that this number will be higher for SADI-S due to its longer common channel.
c. Nutrition deficiency: Limited but relevant published data comparing nutritional outcomes for SADI-S and DS suggests no significant difference in rates of vitamin deficiencies when employing common channel lengths of at least 150 cm and total alimentary limb length is 300 cm.
d. Revision Rate
i. The reported rate of revisions for complications ranges from 0.5–4.9% for the BPD/DS 6. In a seriesof 100 SADI-S patients with at least 5-year follow-up, the rate of revision was 7%, while an earlier report on the same group with a shorter (2-yr) follow-up for half of the patients reported a 2% revision rate, suggesting that the risk of revision increases overtime from 2 to 7%. 7
ii. A rare but unique complication to a loop reconstruction often requiring revision to a RY configuration is retrograde filling of the afferent limb which may lead to chronic nausea with SADI-S. This is obviously absent in a RY configuration 9.
e. Internal hernia: SADI-S supporters claim less risk of internal hernia by avoiding a second intestinal anastomosis. Although this may be obvious, there are no studies comparing internal hernia rate with traditional DS. Moreover, most traditional DS studies reporting on internal hernias: 1) do not specify if “Petersen’s space” was closed; and 2) show that only a small percentage of internal hernias is at the ileoileostomy anastomosis.
6. Do you believe that DS is appropriate as a revisional procedure (Sleeve to DS or RYGB to DS)? What percent excess weight loss should a patient expect in a revisional case to DS?
DS is the optimal revisional procedure for sleeve gastrectomy patients with 1) weight regain; 2) insufficient weight loss <50 % EWL; 3) adequate postoperative weight loss but BMI >40. DS should be cautiously offered to RYGB patients due to is relatively high perioperative morbidity rate. In this case, I prefer a two-stage revision. I anecdotally would expect less EWL for DS when done as a revisional procedure as opposed to primary procedure (approximately 50-75%).
7. Have you revised DS to a longer length of common channel due to nutritional deficiencies?
With a 125 cm common channel and stringent patient selection criteria, I did not have to perform any revision for malnutrition or diarrhea.
8. DS is a relatively a more morbid procedure. With current evidence of effectiveness of SADI, do you think DS will go instinct?
DS withstood the test of time as the most effective procedure for weight loss with studies over 10-year outcomes. I believe the major part of its acute morbidity is related to the lack of surgical training and steep learning curve. The most challenging part of the procedure is the duodenal dissection and the duodenoileostomy irrespective of the RY or loop configuration. The second intestinal anastomosis is less challenging with rare anastomosis related acute complication rate. Leakage at the ileoileostomy appears to be a rare event with none reported in the series of 61 patients who underwent traditional double-anastomosis DS by Cottam et al. and 1 reported in a series of 1000 patients by Biertho et al 11.
The negative stigma about the complexity of the traditional DS has kept away most bariatric surgeons from offering it to their patients and played a “protective role” by having patients referred to high volume surgeons/centers specialized in DS. I believe, this has kept the complication rate low. This has been demonstrated in pancreas surgery literature where outcomes are better at higher volume centers/surgeons as compared to low volume centers/surgeons. For that reason, we should be careful in popularizing a procedure as “the easier alternative to double anastomosis DS” which may encourage unqualified/untrained surgeons to prematurely adopt it. This may increase the incidence of perioperative acute complication rate worldwide.
Finally, there is no doubt that SADI-S has its technical advantages over traditional double anastomosis DS and may result in less long-term complications (bowel obstruction, internal hernia, malnutrition or diarrhea), but this may come at an expense of less expected weight loss, higher long-term weight regain rate, higher revision rate and higher duodenoileostomy leak rate. For now, and until long term loop DS evidence shows the contrary, the double anastomosis DS remains the king and sits on the iron throne.
1. Nelson, L., Moon, R.C., Teixeira, A.F., Galvao, M., Ramos, A., and Jawad, M.A. Safety and effectiveness of single anastomosis duodenal switch procedure: preliminary result from a single institution. Arq Bras Cir Dig. 2016; 29: 80–84
2. Physiopathological Differences After Duodenal Switch And Single Anastomosis Duodeno Ileal Bypass (SADI-S). Amador Garcia Ruiz, Alejandro Bravo Salva, Jordi Elvira López, Jordi Pujol Gebelli. Surgery for Obesity and Related Diseases, Vol. 13, Issue 10, S8
3. Bariatric Surgery Outcomes. Kristoffel R. Dumon,MDa, Kenric M. Murayama,M. Surg Clin N Am 91 (2011) 1313–1338
4. Buchwald, H. and Oien, D.M. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013; 23: 427–436
5. Marceau, P., Biron, S., Hould, F.S. et al. Duodenal switch: long-term results. Obes Surg. 2007; 17: 1421–1430
6. Revision and reversal after biliopancreatic diversion for excessive side effects or ineffective weight loss: a review of the current literature on indications and procedures Philippe A. Topart, M.D., et al. Surgery for Obesity and Related Diseases 11 (2015) 965–972
7. Sanchez-Pernaute, A., Rubio, M.A., Cabrerizo, L., Ramos-Levi, A., Perez-Aguirre, E., and Torres, A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S) for obese diabetic patients. Surg Obes Relat Dis. 2015; 11: 1092–1098
8. Surve, A., Zaveri, H., Cottam, D. et al. A retrospective comparison of biliopancreatic diversion with duodenal switch with single anastomosis duodenal switch (SIPS-stomach intestinal pylorus sparing surgery) at a single institution with two year follow-up. Surg Obes Relat Dis. 2017; 13: 415–42
9. Surve, A., Zaveri, H., and Cottam, D. Retrograde filling of the afferent limb as a cause of chronic nausea after single anastomosis loop duodenal switch. Surg Obes Relat Dis. 2016; 12: e39–e42
10.McConnell DB, O’Rourke RW, Deveney CW. Common channel length predicts outcomes of biliopancreatic diversion alone and with the duodenal switch surgery. Am J Surg 2005;189 (5):536–40.
11.Biertho, L., Lebel, S., Marceau, S. et al. Perioperative complications in a consecutive series of 1000 duodenal switches. Surg Obes Relat Dis. 2013; 9: 63–68
Commentary by Dr. Pullatt and Dr. White:
Disclosure- In our Institute we perform the Standard Laparoscopic Double Anastomosis Duodenal Switch.
Despite convincing evidence that both BPD-DS [1,2] and SADI [3,4] result in superior excess weight loss and resolution of weight-related medical comorbidities when compared directly against procedures including the gold-standard Roux-en-Y gastric bypass, these operations remain vastly underutilized both in the United States, comprising 0.7% of all bariatric procedures , and only slightly higher at 1.1% worldwide according to a recent IFSO survey . The posited explanations for this are many, including increased perioperative morbidity compared to sleeve and gastric bypass, and increased technical challenges with the requisite duodenal dissection, duodenal-ileal anastomosis, and in the case of double-anastomosis DS an ileoileostomy, as well as the metabolic complications unique to the malabsorptive component of these procedures that require stringent patient selection and close longitudinal follow-up.
Contributing to the underutilization of duodenal switch in both of its current forms, and perhaps even the obfuscation of data collection and analysis, is an honest and legitimate confusion regarding the nomenclature of these procedures that needs to be acknowledged. Despite being referenced as bilio-pancreatic diversion with duodenal switch, or BPD-DS, the current form of the double-anastomosis duodenal switch bears little resemblance to the original BPD described and practiced by Scopinaro  in the 1970’s. The modification of the BPD developed in the 1980’s and published in the late 1990’s by Hess and Hess  included a generous sleeve gastrectomy with preservation of the lesser curvature and pylorus, with a duodenoileal anastomosis that proved to have less marginal ulceration and less issues with gastric motility and dumping. As such, the BPD and BPD-DS as it came to be named are physiologically and metabolically distinct operations. Gagner recently suggested dropping the BPD prefix from BPD-DS, and highlights that the oft-dramatic morbidity and mortality data of the original BPD is frequently included in studies of the double-anastomosis duodenal switch .
Consider then the single-anastomosis duodenal switch. Proposed as a novel technique and modification of the double-anastomosis DS by Sanchez et al in 2007 , the more measured restrictive component of a generous sleeve gastrectomy, the mechanical, metabolic, and ulcer-reducing features of pyloric preservation, and the malabsorption-inducing bypass of the duodenum and jejunum of the double-anastomosis DS were retained. Arguably the key featuresof the operation remained the same, with a simple alteration to the reconstruction of the duodenoileostomy from a Roux-en-Y to a loop configuration. With minor variations in sleeve calibration and common channel length generating differently named procedures in the literature including SADI, SADI-S, SIPS, SADS, and Loop DS, confusion among physicians is understandable, and confusion among patients is almost assured. For simplification, and acknowledging that the two are derivations of the same basic procedure, duodenal switch with specification of single or double-anastomosis i.e. SA-DS or DA-DS should be considered. The conversation regarding limb length and sleeve caliber to optimize and individualize the operation can then proceed from a re-centered position.
There are, undoubtedly, differences between the two techniques, and Dr. Cottam and Dr. Waked have presented fabulous arguments in favor of each. DA-DS is currently the only one of the two endorsed by the ASMBS , and therefore the only one reimbursed by insurance in most states and able to be performed without participating in a clinical trial, under IRB approval, or on a cash-pay basis in the US. As such, performance and subsequent data collection for SA-DS is limited to a small handful of institutions. In their latest position statement regarding SA-DS in May of 2016, Dr. Kim as the representative of the Clinical Issues Committee cites insufficient data regarding the safety, efficacy, and procedure-specific complications to consider reclassifying the procedure from investigational to endorsed , the same type of endorsement that set off the dramatic rise in the performance of sleeve gastrectomy . This example shows the power of such an endorsement and highlights the need for a restrained and deliberate approach to a review of quality and mature evidence for any new procedure or technique. Perhaps though, with new data in the last several years it is time to reconsider SA-DS.
Despite its dramatically limited application thus far, the forthcoming data on SA-DS is encouraging. A large multicenter review on SA-DS has found early complication rates as low as 1% ,with 1328 patients having 9 DI leaks (0.6%), 2 marginal ulcerations, 5 DI strictures, 2 cases of alkaline reflux, and no internal hernias at 2 years. Another series of over 1000 individuals had an early complication rate of 7% , on par with the 7% rate attributed to DA-DS in a similar large retrospective series . Early data from a US single institution series discussed in more detail below , and referenced by Dr. Waked above, found a leak rate at the DI in SA-DS of 3% (4/111), with postulation that admixed pancreatic enzymes and bile passing through the anastomosis may contribute to this higher leak rate. Despite the low number overall, this discrepancy between DI leaks will certainly need to be evaluated and monitored as more data becomes available.
Having already achieved ASMBS-endorsed status and with now decades of supportive data, the efficacy and superiority over other Bariatric operations with respect to weight loss and comorbidity resolution of DA-DS is not in question. However, a fair discussion regarding the limited worldwide acceptance of DA-DS, even by its staunchest supporters, has to acknowledge the steep learning curve, longer operative times, and early complication rate that constrain its popularity. Compared to SA-DS, anastomotic complications and internal hernia risk are heightened with the addition of an ileoileostomy, however marginal ulceration of the DI is not a commonly reported major pitfall of the DA-DS as purported above, particularly when compared with RYGB.
Published in February, Moon et al  provide two-year outcome data directly comparing their series of SA-DS vs DA-DS. At 6 and 12 months the % total weight loss between groups was virtually identical, only slightly favoring DA-DS (48.4%) vs SA-DS (44.2%) at 24 months, albeit a non-statistically significant difference. A similar series with two-year comparative outcome data found superior weight loss in DA-DS with 94% excess weight loss (EWL) at two years compared to 87.1% EWL for SA-DS. However, this same study also found significant differences between DA-DS and SA-DS in both early (21% vs 1%) and late (32.2% vs 10.8%) complications . It has been suggested that the longer common channel in a SA-DS may lead to bowel adaptation and higher chance of weight regain, but this seems speculative at this point. Further, improvement or resolution of all measured medical comorbidities was equivalent at all time periods in both of the aforementioned studies. Overall comparable rates of fat-soluble vitamin deficiencies were noted as well. This data echoes other earlier reports on the noninferiority of SA-DS by Torres  and Bouchard . Notably, every series directly comparing the two have found significantly shorter operative times for SA-DS, by 39-48 minutes [17,20]. Readmissions and revisions occur with both operations, and are not discrepant enough to draw any striking conclusions. The growing body of literature, albeit at still relatively short-term follow up, seems to support both the safety and efficacy of SA-DS, as well as noninferiority when compared to DA-DS.
One of the more salient discussion points from this debate and certainly a point of agreement from both sides is the question of duodenal switch as revisional procedure. A large meta-analysis of 7-year data after sleeve gastrectomy showed weight recidivism of 27.8% , confirming what many surgeons have noted anecdotally. DA-DS has previously been vetted as an efficacious staged or revisional procedure from both sleeve gastrectomy and lap band [22-24]. However, even in its relative infancy, SA-DS has also been shown to be safe and provide tremendous additional excess weight loss in revisions from lap band  and sleeve [26,27].
Whether single or double anastomosis duodenal switch is the superior procedure is difficult to determine at this point. The points of contrast seem to be slightly better weight loss with DA-DS, but faster operations with a shorter learning curve and what appears to be a better safety profile with SA-DS. In this case, the operation chosen can be tailored to the specific needs of the individual patient, but the discussion should possibly re-framed to consider that both variants of duodenal switch confer markedly better weight loss and metabolic outcomes than the procedures that make up >99% of the bariatric operations being performed today. The growing body of literature would suggest that the safety and efficacy of SA-DS have been substantiated, and this operation should be reclassified and added to the current scope of bariatric and metabolic practice for its success as both a primary and revisional procedure. In direct comparison to DA-DS, it is reasonable to believe that an endorsement and subsequent dissemination of SA-DS that is technically easier to perform and appears to have at best a much better, and at worst equivalent, safety profile could alter the landscape of the field and see the sustained growth of malabsorptive procedures. We also need to critically assess the need for a Roux Limb post pyloric as this may be overengineering an already effective operation with the non-significant risk of Internal Hernia over the life time of the patient. Of course a roux limb leak may be much easier to manage than a leak at the DI anastomosis in a DA-DS. Long term studies will discern if the weight loss difference may be clinically significant between the two groups.
 Skogar ML, Sundbom M. Duodenal Switch Is Superior to Gastric Bypass in Patients with Super Obesity when Evaluated with the Bariatric Analysis and Reporting Outcome System (BAROS). Obes Surg. 2017;27(9):2308–2316.
 Topart P, Becouarn G, Ritz P. Weight loss is more sustained after biliopancreatic diversion with duodenal switch than Roux-en-Y gastric bypass in superobese patients. Surg Obes Relat Dis. 2013; 9: 526-530.
 Cottam A, Cottam D, Medlin W, Richards C, Cottam S, Zaveri H, Surve A. A matched cohort analysis of single anastomosis loop duodenal switch versus Roux-en-Y gastric bypass with 18-mont follow-up. Surg Endosc.2016; 9: 3958-64.
 Sanchez-Pernaute A, Arrue del Cid E, Herrera M, Matia P, Aguirre E, Serrano I, Eguizabal P, Torres A. Prospective nonrandomized comparison between single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) and gastric bypass, for the treatment of morbid obesity. Surg Obes Relat Dis. 2016; 12: S22-S23
 “Estimate of Bariatric Surgery Numbers, 2011-2017.” ASMBS, June 2018. asmbs.org/resources/estimate-of-bariatric-surgery-numbers
 Angrisani L, Santonicola A, Iovino P, et al. Bariatric Surgery and Endoluminal Procedures: IFSO Worldwide Survey 2014. Obes Surg. 2017;27(9):2279–2289
 Scopinaro N, Gianetta E, Pandolfo N, Anfossi A, Berretti B, Bachi V. Bilio-pancreatic bypass. Proposal and preliminary experimental study of a new type of operation for the functional surgical treatment of obesity. Minerva Chir. 1976; 31: 560-566
 Hess DS, Hess DW. Biliopancreatic diversion with a duodenal switch. Obes Surg. 1998 Jun; 8(3):267-282
 Gagner M. For whom the bell tolls? It is time to retire the classic BPD (Bilio-Pancreatic Diversion) operation. Surg Obes Relat Dis. 2019; in press
 Sánchez-Pernaute A, Rubio Herrera MA, Pérez-Aguirre E, et al. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007;17(12):1614–8
 “Endorsed Procedures and Devices.” ASMBS, March 2019. asmbs.org/resources/endorsed-procedures-and-devices?/resources/approved-procedures
 “Position statement on single-anastomosis duodenal switch.” ASMBS. May 2016. asmbs.org/resources/position-statement-single-anastomosis-duodenal-switch
 Surve A, Cottam D, Sanchez-Pernaute A, Torres A, et al. The incidence of complications associated with loop duodeno-ileostomy after single-anastomosis duodenal switch procedures among 1328 patients: a multicenter experience. Surg Obes Relat Dis. 2018; 14(5):594-601
 Topart P, Becouarn G. The single anastomosis duodenal switch modifications: a review of the current literature on outcomes.Surg Obes Relat Dis. 2018; 13(8):1306-1312
 Biertho L, Lebel S, Marceau S, et al. Perioperative complications in a consecutive series of 1000 duodenal switches. Surg Obes Relat Dis. 2013; 9(1):63-68
 Moon RC, Gaskins L, Teixeira AF, Jawad MA. Safety and Effectiveness of Single-Anastomosis Duodenal Switch Procedure: 2-Year Result from a Single US Institution. Obes Surg. 2018; 28(6): 1571-1577
 Moon RC, Kirkpatrick V, Gaskins L, Teixeira A, Jawad MA. Safety and effectiveness of single- versus double-anastomosis duodenal switch at a single institution. Surg Obes Relat Dis. 2019; 15(2):245-252
 Surve A, Zaveri H, Cottam D, Belnap L, Cottam A, Cottam S. A retrospective comparison of biliopancreatic diversion with duodenal switch with single anastomosis duodenal switch (SIPS-stomach intestinal pylorus sparing surgery) at a single institution with two year follow-up. Surg Obes Relat Dis. 2017;13:415–22
 Sanchez-Pernaute A, Rubio M, Cabrerizo L, Ramos-Levi A, Perez-Aguirre E, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S) for obese diabetic patients. Surg Obes Relat Dis. 2015; 11: 1092-1098.
 Bouchard P, Bougie A, Abri M, et al. Single Anastomosis Duodeno-ileal Bypass with Sleeve Gastrectomy (SADI-S): Safety, Preliminary Outcomes from a Single Institution Prospective Cohort Study. Surg Obes Relat Dis. 2018; 14(11):S102-103
 Clapp B, Wynn M, Martyn C, Foster C, O’Dell M, Tyroch A. Long term (7 or more years) outcomes of the sleeve gastrectomy: a meta-analysis. Surg Obes Relat Dis. 2018; 14(6):741-747
 Shimizu H, Annaberdyev S, Motamarry I, Kroh M, Schauer PR, Brethauer SA. Revisional bariatric surgery for unsuccessful weight loss and complications. Obes Surg. 2013; 23:1766–73.
 Himpens J, Dobbeleir J, Peeters G. Long-term results of laparoscopic sleeve gastrectomy for obesity. Ann Surg. 2010;252:319–24.
 Morales MP, Wheeler AA, Ramaswamy A, Scott JS, de la Torre RA. Laparoscopic revisional surgery after Roux-en-Y gastric bypass and sleeve gastrectomy. Surg Obes Relat Dis2010; 6:485–90.
 Wu A, Tian J, Cao L, Gong F, Wu A, Dong G. Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) as a revisional surgery. Surg Obes Relat Dis. 2018; 14(11):1686-1690
 Sanchez-Pernaute A, Rubio MA, Conde M, Arrue E, Perez-Aguirre E, Torres A. Single-Anastomosis duodenoileal bypass as a second step after sleeve gastrectomy. Surg Obes Relat Dis.2015; 11(2):351-355
 Moon RC, Fuentes AS, Teixeria AF, Jawad MA. Conversions after Sleeve Gastrectomy for Weight Regain: to Single and Double Anastomosis Duodenal Switch and Gastric Bypass at a Single Institution. Obes Surg. 2019; 29(1):48-53
Tarek Waked, MD, FACS, FASMBS
Director of Metabolic & Bariatric Surgery
Nanticoke Memorial Hospital
Dr. Daniel Cottam
Director of the Bariatric Medicine Institute
Salt Lake City, USA
Rana C Pullatt MD MS MRCS FACS FASMBS
Diplomate in Obesity Medicine
Clinical Director Bariatric & Robotic Surgery
Medical University of South Carolina
Director Bariatric Surgery VISN-7
Benjamin L White, MD
Medical University of South Carolina
Bariatric surgery has well known long term complications albeit these happen in a small percentage of patients, it is very important for us as Bariatric surgeons to be equipped and ready to handle different spectrum of complications.
I’m presenting a case of a middle aged female whom I had performed a robotic gastric bypass for about a year and a half ago. Her starting preoperative weight was 302 lbs with a BMI of 50.3 kg/m2. She did very well but unfortunately came back for follow up only at 3 months but did not show up for later follow ups.
She now presented to the ER after she had lost a significant amount of weight and currently weighs 145 lbs with a BMI of 24.2 kg/m2. Unfortunately started smoking and alcohol drinking however stopped drinking 2 months prior to presentation. She reported 2 days of worsening upper abdominal pain and chills and feeling unwell at home. She had a WBCs of 15.7 and the attached CT scan images which suggested a perforated marginal ulcer (Fig 1-3).
As such and being an uncontained perforation , We decided to proceed to the operating room for a diagnostic laparoscopy and omental patch repair of the ulcer. However on entering the abdominal cavity we realized that this complication is more catastrophic than a mere perforated ulcer. There were several abscess cavities in the Left upper quadrant encasing the gastrojejunal anastomosis and the roux limb, these were drained and this unroofed an almost completely disrupted gastrojejunal anastomosis at 270 degrees only attached by a 5mm segment in the posteromedial aspect. The thought was to repair the anastomosis but due to the marked inflammation and edema of the roux limb this was impossible.
A healthy part of the roux limb was identified just below that area and would reach the pouch without tension. The patient had been completely stable at this point and on no pressors as such I Decided to recreate the anastomosis to hopefully avoid the risk of resuturing an already diseased segment which increases the chances of postoperative leaks.
We then tried to dissect a fresh part of the pouch however this was markedly adherent with inflammatory adhesions to the gastric remnant and it was felt unsafe to proceed with proximal dissection of the pouch . As such the Roux limb only was divided and the health Roux limb was re-anastomosed to the pouch. Initially we tried a straight stapler however due to the thickness of the tissue we decided to do a two layer hand sewn anastomosis using an absorbable barbed suture which worked well in this case. This was done over an 18 F nasogastric tube.
Because this is a high risk anastomosis and relying on oral feeding postoperatively is likely not the safest option , the decision was made to place a feeding tube in the gastric remnant.
The patient recovered well from anesthesia and was admitted to the floor. An UGI study was obtained on POD#5 (Fig.4) which did not show any leaks as such, the patient was started on water only PO and feeding through the G-tube. She was discharged home on POD#6 in a good condition
Hany Takla, MD , FACS
General and Bariatric Surgeon
Middlesex Surgical associates
Winchester hospital, Winchester , MA
Clinical instructor Tufts school of medicine
Links to the post:
Upper gastrointestinal-tract defects (UGID) in the bariatric surgery patient pose a daunting problem for the surgeon tasked with management. UGID may present as acute perforations, staple line leaks or longstanding fistula. Recently, endoscopic management of UGID has become more mainstream and an emerging body of evidence supports the use of endoscopic options in the bariatric patient with an UGID. At our institution, endoscopic therapy is now offered as first-line treatment in the majority of bariatric patients with UGIDs and graduates of our fellowship program are capable of both endoscopic and surgical management of these issues. Here we briefly review endoscopic options available for management of UGID in the bariatric surgery population (Table 1).
Through the scope clips (TTSC) are small and easily deployed through the 2.8 mm working channel of an upper endoscope. These clips work well in small, acute perforations where the small closing force provided by the clips is sufficient to bring the fresh mucosal edges together. They do not provide full thickness closure, but are widely available in most endoscopy units.
Larger Over-the-Scope clips such as the OTSC (Ovesco Endoscopy, Tubingen, Germany) and the Padlock Clip (US Endoscopy, Mentor, OH) are capable of full thickness closure of defects up to 2cm in size (Figure 1). These biocompatible nitinol clips are affixed to the tip of the endoscope, and then delivered under direct visualization at the orifice of the UGID. They are less widely available, require endoscope removal to affix and can be difficult to remove, but they can close larger defects with full thickness bites of tissue.
Self-expanding covered metal stents are approved by the United States Food and Drug Administration for the purpose of opening and stenting obstructing malignant lesions in the esophagus. A widely accepted off-label use of these stents is to divert the enteric stream away from the UGID to allow for both source control and time for the defect to heal. Stents are capable of covering larger, more complex defects, but they may migrate and do eventually require endoscopic removal. The Niti-S Beta stent (TaeWoong medical, South Korea) has a unique double bump shape designed to prevent migration when placed for bariatric UGID management, but the device is not available in the US. The radial wall tension stents place on a UGID is somewhat counterintuitive to the healing process, but literature suggests they can be effectively used to manage UGID in the bariatric patient.
Endoscopic suturing of an UGID is possible with either the Overstitch, or the recently released Overstitch Sx (Apollo Endosurgery, Austin, TX). The Overstitch requires a double channel Olympus upper endoscope, but the Overstitch Sx is capable of affixing to the distal tip of more than 40 different types of upper endoscopes (Figure 2). These endoscopic suturing platforms are capable of taking full-thickness bites and allow the endoscopist a large range of freedom with regards to suturing patterns, suture material, bite location and tension of the closure. The devices take practice to use effectively and require luminal working space to maneuver, but are capable of closing larger and more complex UGID than over-the scope clips.
Endolumenal Vacuum (E-VAC) therapy has recently become a viable option for management of UGID with associated abscess cavities or UGID too complex to close. Commercially available versions (Endo-SPONGE, B. Braun Melsungen AG, Melsungen, Germany)are not available in the US, so the device must be constructed by the endoscopist by suturing a piece of black Granufoam (KCI Medical, Pennsauken Township, NJ)to a nasogastric tube and endoscopically delivering it via the oropharynx to the UGID cavity (Figure 3). The E-VAC is then brought out through the nose and placed to continuous suction. The sponge is changed endoscopically every 2-7 days until the cavity closes down. Most patients remain in the hospital to undergo continuous suction and repeated E-VAC changes.
Many endoscopic modalities have proven quite effective at the management of UGID in the bariatric surgery patient. Whichever method is used, the provider must be familiar with its application, advantages, and limitations. Additionally, any patient who is demonstrating clinical instability, shock, or generalized sepsis should be treated with traditional surgical approaches. All periprocedural aspects of the patient’s care should be addressed, including maximizing nutrition, treating infection with source control and antibiotics, relieving downstream obstructions, and removing foreign bodies within the UGID. No single therapy represents the perfect solution to all clinical scenarios, and often we will employ various therapies in sequence and/or in parallel to achieve long-term closure.
Eric M. Pauli, MD FACS FASGE
Associate Professor of Surgery
Penn State Milton S. Hershey Medical Center, Hershey, USA
Joshua Winder, MD
General Surgery Resident
Penn State Milton S. Hershey Medical Center, Hershey, USA
An example of the OTSC (Ovesco Endoscopy, Tubingen, Germany) on the right, and the Padlock Clip (US Endoscopy, Mentor, OH) on the left.
Therefore, I scoped using a colonoscope and looked at the remaining rectum and polyp was about 1 cm from our transection site (where tattoo was).
A. The Overstitch (Apollo Endosurgery, Austin, TX) as it appears on the tip of an endoscope. B. The recently released Overstitch Sx (Apollo Endosurgery, Austin, TX).
Endolumenal vacuum (E-vac). This was created by cutting a black sponge to the size of the abscess cavity and suturing it to the tip of an NG tube.
An analysis of 130,772 patients in USA was conducted to study the routine practice of bariatric surgeons in addressing the hiatus hernia during laparoscopic sleeve gastrectomy (SG) and Roux en Y Gastric bypass (RYGB). Majority of the cases done were SG (69.5%) compared to RYGB (30.5%). Interestingly simultaneous hiatus hernia repair (HHR) was more common in the SG patients (21%) compared to the RYGB (10.8%) in spite of less GERD in these patients. This practice in management of HH will confound the result interpretation in long term, particularly that related to GERD.
Docimo S Jr, Rahmana U, Bates A, Talamini M, Pryor A, Spaniolas K. Concomitant Hiatal Hernia Repair Is more Common in Laparoscopic Sleeve Gastrectomy than During Laparoscopic Roux-en-Y Gastric Bypass: an Analysis of 130,772 Cases. Obes Surg. 2019 Feb;29(2):744-746.
What incentivized you to bring up the question of hiatal hernia repair in bariatric patients?
Gastro-esophageal reflux disease (GERD) is prevalent problem in both non-obese patients as well as our morbidly obese population. Many studies have demonstrated links between body mass index and also GERD. Furthermore, hiatal hernias have also been linked to GERD. Our bariatric surgical group decided to evaluate the hiatal hernia repair in bariatric patients considering no significant consensus or guidelines currently exist.
You mention that around 20% of sleeve patients had a concomitant hiatal hernia repair. Do you believe that 20% of the bariatric population have hiatal hernias?
We do believe that a 20% prevalence of hiatal hernias in our bariatric population to be fairly accurate and is in fact likely underestimated. Previous studies evaluating preoperative upper GI contrast studies have noted a prevalence of 37%.1 Some studies even suggest that UGI studies underestimate the incidence of hiatal hernias in our bariatric surgery population. One study in particular demonstrate an incidence of 39% on UGI preoperatively, however, intraoperative examination demonstrated that 61% of their patients undergoing bariatric surgery were noted to have a hiatal hernia.2
3- Does the fact that Sleeve is associated with de novo GERD is leading surgeons to over dissect the hiatus in an attempt to decrease post op reflux?
A recent publication by Sebastianelli et al.3 evaluated patients who underwent upper endoscopy before a sleeve gastrectomy and approximately 5 years after surgery. They noted a prevalence of GERD symptoms, erosive esophagitis, and the use of PPIs at 22%, 10%, and 22% before the SG and at 76%, 41%, and 52% at the time of followup.3 These findings certainly suggest all surgeons performing a sleeve gastrectomy perform their due diligence in regards to evaluating the hiatus for a hiatal hernia. If there is evidence of a hiatal hernia, it should be repaired.
What is your current preoperative work up for your bariatric patients (endoscopy, UGI, every patient, selective)?
Currently we do perform an upper endoscopy on the majority of our patients who are candidates for bariatric surgery. For patients with complaints of reflux, we also place a BRAVO probe for additional evaluation. In those patients with significantly high body mass indexes, we do suggest they undergo an UGI evaluation rather an upper endoscopy.
What is your current practice regarding bariatric patients with a known hiatal hernia or paraesophageal hernia? Do these patients get bypass or sleeve?
For most patients with a known paraesophageal hernia, we typically proceed with a roux-en-y gastric bypass with repair of the hiatal hernia. Small hiatal hernias can be repaired concomitantly with both a roux-en-y gastric bypass and a sleeve gastrectomy and in most situations the decision is made based on a case-by-case basis. Generally, if the patient has a symptomatic (reflux) hiatal hernia, we will more likely perform a roux-en-y gastric bypass. Some controversy still exists regarding concomitant repair of the hiatus during a bariatric surgical procedure. Some suggest that a hiatal hernia repair is more challenging in morbidly obese patients. Therefore, some suggest performing an anterior approach for a small sliding hernia and a posterior and/or anterior repair for larger, para-esophageal hernias.4 Konstantinos Spaniolas, MD, a co-author of the study states, “GERD and hiatal hernias are just a small part of the complex puzzle of shared decision making in bariatric surgery.”
Do you explore the hiatus in every sleeve case?
We interrogate both the anterior and posterior hiatus during our bariatric procedures. If there is a suggestion of a hiatal hernia we do dissect the hiatus and repair the defect concurrently with our bariatric procedure. We also thoroughly evaluate our preoperative imaging and/or upper endoscopy to determine if a hiatal hernia exists.
Do you repair every hiatal hernia in a bypass case?
For hiatal hernias noted intra-operatively during a roux-en-y gastric bypass, we also proceed with a hiatal hernia repair and complete the gastric bypass concomitantly.
1. Che F, Nguyen B, Cohen A, Nguyen NT. Prevalence of hiatal hernia in the morbidly obese. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):920-4.
2. Boules M, Corcelles R, Guerron AD, Dong M, Daigle CR, El-Hayek K, Schauer PR, Brethauer SA, Rodriguez J, Kroh M. The incidence of hiatal hernia and technical feasibility of repair during bariatric surgery. Surgery. 2015 Oct;158(4):911-6; discussion 916-8.
3. Sebastianelli L,, Benois M, Vanbiervliet G, Bailly L, Robert M, Turrin N, Gizard E, Foletto M, Bisello M, Albanese A, Santonicola A, Iovino P, Piche T, Angrisani L8, Turchi L9, Schiavo L, Iannelli A. Barrett's Esophagus: Results of a Multicenter Study. Obes Surg. 2019 Jan 21
4. Boules M, Corcelles R, Guerron AD, Dong M, Daigle CR, El-Hayek K, Schauer PR, Brethauer SA, Rodriguez J, Kroh M. The incidence of hiatal hernia and technical feasibility of repair during bariatric surgery. Surgery. 2015 Oct;158(4):911-6
Salvatore Docimo Jr, DO
Assistant professor of surgery at Stony Brook Medicine, NY,
Salvatore Docimo Jr, DO Assistant professor of surgery at Stony Brook Medicine, NY,
The debate is on: Best revisional procedure for Sleeve Gastrectomy (SG).
With more and more SG being performed worldwide the new debate is the choice of
best revisional operation after initial SG. Lee Y et al performed this systematic review
and looked for articles which compared the efficacy and safety of SADI and BPD-DS
versus RYGB as revisional procedure of choice for SG. There were no prospective
studies found. Only 377 patients from 6 retrospective cohort studies were eligible. The
primary outcome of total weight loss (TWL) was significantly higher in the SADI/BPD-DS
group. A bias of higher initial BMI was noted in that group. The secondary outcomes of
length of stay, adverse events or co-morbidity resolution (diabetes, hypertension and
hypercholesterolemia) showed no difference.
Lee Y, Ellenbogen Y , Doumouras AG , Gmora S , Anvari M , Hong D. Single- or double-
anastomosis duodenal switch versus Roux-en-Y gastric bypass as
a revisionalprocedure for sleeve gastrectomy: A systematic review and meta-analysis.
Surg Obes Relat Dis. 2019 Jan 31. S1550-7289(18)31213-9.
Obesity and metabolic syndrome are associated with colorectal neoplasia (CRN) and cancer (CRC). However, there is no prospective study verifying these claims. Authors were able to gain consent and enrol 168 patients for screening colonoscopy (SC) before bariatric surgery. Data regarding smoking, drinking, fasting blood sugar (FBS), insulin, HbA1c, c-peptide, lipid profile and vitamin D were collected. The cohort was further divided into 40 – 49 years age and 50 – 65 years for comparison. 27.9% patients had CRN out of which 8.9% had advanced CRN and 0.6% had CRC. CRN rate was higher in the ≥ 50 years age group compared to ≤ 50 years age group. Excluding FBS and HbA1c, which were higher in the ≥ 50 years age group, rest of the parameters were comparable. They concluded that in the age >50 years patients, SC should be a part of the pre-operative work up.
Toydemir T. Özgen G, Çalıkoğlu İ, Ersoy Ö, Yerdel MA. A Comparative Study Evaluating the Incidence of Colorectal Neoplasia(s) in Candidates for Bariatric Surgery by Screening Colonoscopy, 40-49 Versus 50-65 Years Old: a Preliminary Study. Obes Surg. 2019 Mar 15.
Gastrooesophageal reflux disease (GERD) after Sleeve gastrectomy (SG) is a controversial and heavily debated topic. This systematic review looks at prevalence of GERD, oesophagitis and barrett’s oesophagus after primary SG in morbid obese patients. They found that in 10,718 patients from 46 studies, the increase in post operative GERD was 19% and an additional 23% developed de novo reflux. Barrett’s oesophagus (BE) was found in 8% of patients and 28% had oesophagitis. Conversion to RYGB was needed in 4% of patients. With the increase in the number of SG performed worldwide they raise a question whether these consequences need to be included in the consent process routinely. They also put the questions out there regarding the need for routine postoperative endoscopic surveillance.
Yeung KTD1, Penney N, Ashrafian L, Darzi A, Ashrafian HA Ann Surg. Does Sleeve Gastrectomy Expose the Distal Esophagus to Severe Reflux?: A Systematic Review and Meta-analysis. Ann Surg. 2019 Mar 20.
Sleeve gastrectomy (SG) and Roux En Y Gastric Bypass (RYGB) are the top two bariatric operations performed worldwide. However, there is no consensus regarding the choice of the procedure for specific group of patients. Data from the 3 nations of 47,101 primary bariatric operations included 70.1% RYGB and 29.9% SG. Significantly more number of RYGB patients satisfied International guidelines for having bariatric surgery compared to SG. Interestingly the rate of severe complications and 30-day mortality was same in both groups. Readmission rate was significantly higher in the RYGB group. There was great variation in weight loss noted in SG patients by different hospital compared to that of RYGB. The total weight loss (TWL) of 20% was significantly higher in the RYGB patients compared to SG. Both procedure were considered safe.
Poelemeijer YQM1,2, Liem RSL3,4, Våge V5, Mala T6, Sundbom M7, Ottosson J8, Nienhuijs SW9 . Gastric Bypass Versus Sleeve Gastrectomy: Patient Selection and Short-term Outcome of 47,101 Primary Operations from the Swedish, Norwegian, and Dutch National Quality Registries. Ann Surg. 2019 Mar 20.