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Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

RecruitingNAAges 18 Years - 60 YearsAllLaval University
NCT05242835 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, esp

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📋 Eligibility rules (as published)
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
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What it tests

  • Standard duodenal switch
  • Single-anastomosis duodenal switch
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Where

1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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