Improving outcomes for patients with failed sleeve gastrectomy using a new surgical approach
Official title: Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery
Run by Laval University · NCT05242835 · Data updated 2026-11-12
This study is testing a new type of surgery called SADI-S to see if it can help people who didn't have success with their previous sleeve gastrectomy lose weight and improve their health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 151 (estimated) |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Status | Recruiting |
| Started | February 3, 2023 |
| Main results expected | January 2027 |
| Study ends | March 2027 |
| Registry record updated | December 8, 2025 |
| Trial ID | NCT05242835 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who had sleeve gastrectomy at least 18 months prior and still meet the NIH criteria for bariatric surgery.
✕Probably not a fit
Patients who are not eligible include those with a BMI below 35 kg/m2, pregnant individuals, or those with certain medical conditions like cirrhosis or inflammatory bowel disease.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of the Single-Anastomosis Duodenoileal Switch (SADI-S) as a revisional surgery for patients who have experienced failure after sleeve gastrectomy. The study aims to compare this newer, simplified surgical technique with the standard duodenal switch procedure. By focusing on patients who meet specific criteria related to their previous weight loss surgery, the trial seeks to provide evidence on the safety and efficacy of SADI-S in managing obesity. The goal is to address the significant rates of failure associated with sleeve gastrectomy and improve patient outcomes.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective surgical option for patients struggling with weight regain after sleeve gastrectomy.
How similar studies have gone: While there is limited prospective data on the SADI-S approach, similar studies on revisional bariatric surgeries have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Laurent Biertho, MD — Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study coordinator: Mélanie Nadeau, MSc
- Email: melanie.nadeau@criucpq.ulaval.ca
- Phone: 418-656-8711
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.