NCT05242835 Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery
| NCT ID | NCT05242835 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laval University |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 151 participants |
| Start Date | 2023-02-03 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 151 participants in total. It began in 2023-02-03 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Laurent Biertho, MD
PRINCIPAL INVESTIGATOR
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Frequently Asked Questions
Who can join the NCT05242835 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05242835 currently recruiting?
Yes, NCT05242835 is actively recruiting participants. Contact the research team at melanie.nadeau@criucpq.ulaval.ca for enrollment information.
Where is the NCT05242835 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT05242835 clinical trial?
NCT05242835 is sponsored by Laval University. The principal investigator is Laurent Biertho, MD at Institut universitaire de cardiologie et de pneumologie de Québec, University Laval. The trial plans to enroll 151 participants.
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