Single Anastomosis Versus Standard Duodenal Switch

Study Overview
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Brief Summary
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Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Recently, a  simplified  technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS. The overall objective of this study is to assess in a prospective randomized blinded trial, the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.

Detailed Description
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Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Our team, with more than 4000 BPD-DS performed since the early 1990's, is recognized internationally for its expertise with this specific procedure. Recently, a  simplified  technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS. This new procedure, called Single Anastomosis Duodenal Switch has the potential benefit of decreasing the complexity of the standard BPD-DS by avoiding one of the two intestinal anastomoses usually needed. This could potentially decrease the rate of peri-operative complications and increase access to this type of surgery. However, the length of the common channel (250cm) is more than doubled compared to standard BPD-DS, which could also change significantly the outcomes of the procedure itself. Indeed, the length of the common channel conditions the absorption of fat and fat-soluble vitamins. Currently, the scientific literature regarding this procedure is scarce, with only one author who published his 2-years outcomes, in a cohort study of 100 patients. In addition, this report presents major limitations. In example, the length of the omega loop was increased from 200 to 250cm during the course of the study, in order to decrease the rate of protein deficiency and reoperation for malnutrition. This and other limitations make it hard to assess the actual results of the technique. The overall objective of this study is to assess in a stronger study design (i.e. a prospective randomized single blinded trial), the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.

Official Title
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Single Anastomosis Versus Standard Duodenal Switch - a Prospective Randomized Single-blinded Trial

Conditions
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Obesity, Morbid Obesity

Intervention / Treatment
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* Procedure: Standard Duodenal Switch
* Procedure: Single Anastomosis Duodenal Switch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years and ≤60 years Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35 Give written informed consent Exclusion Criteria: Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study: Presence of the following baseline comorbidities: Inflammatory bowel disease (IBD), Cirrhosis History of gastric or duodenal ulcers Preoperative hypoalbuminemia (<35 g/L) History of severe renal, hepatic, cardiac or pulmonary disease Past esophageal, gastric or bariatric surgery Type 1 Diabetes Pregnancy Evidence of psychological problem that may affect the capacity to understand the project and to comply with the medical recommendations History of drug use or alcohol abuse in the last 6 months History of gastro-intestinal inflammatory diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BPD-DS<br>Biliopancreatic diversion with Duodenal Switch (BPD-DS), with Sleeve gastrectomy, including a 100cm common channel and 150cm stric alimentary limb | Procedure: Standard Duodenal Switch<br> <br> * Other names: BPD-DS;|
| Experimental: SADI<br>Single-Anastomosis Duodeno-Ileal anastomosis (SADI) with Sleeve Gastrectomy, including a 250cm common channel | Procedure: Single Anastomosis Duodenal Switch<br> <br> * Other names: SADI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess weight loss | Excess weight loss at 2 years of follow-up %EWL (Excess weight loss based on an ideal BMI = 25.) and change in BMI as compared to preoperative reference values | 2 years | 
| Rate of protein deficiency or insufficiency | Rate of protein deficiency (<35gr/l) or insufficiency (<30gr/l) | from baseline up to 60 months | 
| Mortality rate | Rate of mortality | from baseline up to 60 months | 
| BMI | change in BMI at 2 years follow-up as compared to preoperative reference values | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | overall and surgery-specific complications | from baseline up to 60 months | 
| Cure rate of comorbidities | Remission rate for comorbidities, including T2D, Hypertension, dyslipidemia, sleep apnea | from baseline up to 60 months | 
| Rate of minerals and vitamin deficiencies | Rate of deficiency and insufficiency in mineral and vitamins | from baseline up to 60 months | 
| Body composition by bioimpedance measures | body fat composition (%) assessed by biompedance | from baseline up to 60 months | 
| Change in quality of life | 36-item short form survey score from 0 to 100 | from baseline up to 60 months | 
| Change in quality of life | Bariatric Analysis and Reporting Outcomes System score from -7 to 9 | from baseline up to 60 months | 
| Change in quality of life | Laval Questionnaire score from 0 to 7 | from baseline up to 60 months | 
| Change in quality of life | GastroIntestinal Quality of Life Index from 0 to 144 | from baseline up to 60 months | 
| Change in gatroesophageal reflux symptom | GastroEsophageal Reflus Disease Score from 0 to 72 | from baseline to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery