Improving outcomes for patients with failed sleeve gastrectomy using a new surgical approach
Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 151 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT05242835 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals who had sleeve gastrectomy at least 18 months prior and still meet the NIH criteria for bariatric surgery.
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.
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 performed: While there is limited prospective data on the SADI-S approach, similar studies on revisional bariatric surgeries have shown promising results.
Eligibility criteria
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 this trial is running
Québec, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.