Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

Study Overview
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Brief Summary
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Sleeve gastrectomy (SG) has become the most commonly performed weight loss surgery, accounting for 60% of all bariatric operations worldwide. While technically easier with less side-effects and nutritional risks than other operations, SG is also associated with a higher risk of failure (20 to 40%). In such case, the most effective option consists in adding an intestinal bypass called the Biliopancreatic Diversion with Duodenal Switch (BPD-DS). This surgery is, however, technically challenging and yields a significant risk of complications, nutritional deficiencies or gastro-intestinal side-effects. Recently, a simplified version of the Standard DS, called Single-Anastomosis Duodenoileal Switch (SADI-S) was endorsed by surgical societies as one of the approved bariatric procedures. There is currently no prospective or randomized data to support the effectiveness of this new procedure, especially as a revisional approach. The Overall Objective of this randomized controlled trial project is to establish the clinical benefits of the SADI-S as a revisional surgery after SG, while also considering critical issues related to sex and gender. The investigator Overall Hypothesis is that the SADI-S represents a relevant revisional option for weight loss and metabolic recovery in women and men suffering from severe obesity who had a previous SG. The investigator propose to address the following research question. Research Question: What are the clinical effects of SADI-S compared to standard DS when used as a revisional procedure after SG, in patients with obesity? Participants who need revisional surgery after SG will be enrolled in a prospective, randomized, double-blind (patient-evaluator), non-inferiority trial comparing SADI-S vs DS. The primary outcome will be 12-month excess weight loss. Secondary outcomes will be perioperative complications, risk of malnutrition, quality of life and gastrointestinal side effects. The investigator hypothesize that SADI-S offers similar weight loss compared to standard DS, but a lower risk of complications and nutritional deficiencies. With the increase in the number of bariatric operations performed worldwide and the recent endorsement of the SADI-S as a regular procedure, reliable clinical data are urgently needed. The present proposal will directly address this knowledge gap.

Official Title
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Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

Conditions
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Obesity, Obesity, Morbid

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: had sleeve gastrectomy a minimum of 18 months before still meet the NIH criteria for bariatric surgery (BMI≥35kg/m2 with major comorbidities or BMI≥40kg/m2) or patients with EWL<50% or significant weight regain (≥20%EWL) Exclusion Criteria: general contra-indication for bariatric surgery BMI<35kg/m2 pregnancy cirrhosis abnormal bowel habits including irritable bowel syndrome and inflammatory bowel disease

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: biliopancreatic diversion with duodenal switch<br>Patient randomized for a the standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb) | Procedure: Standard duodenal switch<br>* Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)<br>* Other names: BPD-DS;|
| Experimental: Single-anastomosis duodeno-ileal anastomosis<br>Patient randomized for a single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel) | Procedure: Single-anastomosis duodenal switch<br>* Single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)<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 | Percentage of excess weight loss mobilized in response to surgery | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peroperative complications | Complications graded with Clavien classification | from baseline up to 60 months | 
| Risk of malnutrition | Risk of malnutrition assessed through measurement of its risk being mild (albumin<35g\L), moderate (albumin<30g/L) or severe (albumin<25g/L) | from baseline to 60 months | 
| Change in quality of life (SF-36) | 36-item short form survey evaluating quality of life on a scale form 0 to 100 | from baseline to 60 months | 
| Change in quality of life (BAROS) | Bariatric Analyses and Reporting Outcomes System score form -7 to 9 | from baseline to 60 months | 
| Change in quality of life (QLaval) | Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7 | from baseline to 60 months | 
| Gastro-intestinal side effects | Evaluation of gastro-intestinal side effects with the Gastro-Intestinal Quality of Life Index from 0 to 144 | from baseline to 60 months | 
| Change in nutritional status (calcium) | Change in nutritional status based on blood analysis of calcium (mmol/L) | from baseline to 60 months | 
| Change in nutritional status (ferritin) | Change in nutritional status based on blood analysis of ferritin (ug/L) | from baseline to 60 months | 
| Change in nutritional status (TIBC) | Change in nutritional status based on blood analysis of TIBC (umol/L) | from baseline to 60 months | 
| Change in nutritional status (iron) | Change in nutritional status based on blood analysis of iron (umol/L) | from baseline to 60 months | 
| Change in nutritional status (prealbumin) | Change in nutritional status based on blood analysis of prealbumin (g/L) | from baseline to 60 months | 
| Change in nutritional status (transferrin) | Change in nutritional status based on blood analysis transferrin (g/L) | from baseline to 60 months | 
| Change in nutritional status (vitamin A) | Change in nutritional status based on blood analysis of vitamin A (umol/L) | from baseline to 60 months | 
| Change in nutritional status (vitamin D3) | Change in nutritional status based on blood analysis of vitamin D3 (nmol/L) | from baseline to 60 months | 
| Change in nutritional status (parathormone) | Change in nutritional status based on blood analysis parathormone (ng/L) | from baseline to 60 months | 
| Change in food intake | Evaluation of the change in food intake using a web-based food frequency questionnaire (kcal/day) | from baseline to 60 months | 
| Change in eating behavior | Change of eating behavior using the Three-Factor Eating Questionnaire evaluating cognitive restraint of eating on a scale from 0 to 20, disinhibition on a scale from 0 to 16 and hunger on a scale from 0 to 15 | from baseline to 60 months | 
| Change in food addiction | Change of eating behavior using the Yale Food Addiction Scale that includes a symptom count scale from 0 to 7 reflecting the number of addiction-like criteria endorsed and a dichotomous evaluation that indicates whether a threshold of three or more symptoms plus clinically significant impairment or distress has been met | from baseline to 60 months | 
| Change in binge eating behavior | Change of eating behavior using the Binge Eating scale from 0 to 46 | from baseline to 60 months | 
| Evolution of obesity related diseases | Remission rate for comorbidities, including T2D, hypertension, dyslipidemia, sleep apnea according to the ASMBS definition of outcomes reporting | 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