Comparing two types of duodenal switch surgeries for obesity treatment
Single Anastomosis Versus Standard Duodenal Switch - a Prospective Randomized Single-blinded Trial
NA · Laval University · NCT04767490
This study is testing a new type of weight loss surgery to see if it works better than the standard surgery for people with severe obesity.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Laval University (other) |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT04767490 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a new surgical technique called Single Anastomosis Duodenal Switch compared to the standard Duodenal Switch procedure for treating morbid obesity. The study aims to assess outcomes such as weight loss and remission of Type 2 Diabetes through a prospective randomized blinded approach. The new technique simplifies the surgery by reducing the number of intestinal connections, which may lower complication rates and improve access to this treatment. Participants will be closely monitored and evaluated to determine the long-term effects of each procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 with a BMI of 35 or higher who meet the criteria for bariatric surgery.
Not a fit: Patients with significant comorbidities, previous bariatric surgeries, or certain psychological issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less complex and safer surgical option for patients with morbid obesity.
How similar studies have performed: While the scientific literature on this new technique is limited, it builds on established bariatric procedures that have shown success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years and ≤60 years * Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35 * Give written informed consent Exclusion Criteria: Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study: * Presence of the following baseline comorbidities: * Inflammatory bowel disease (IBD), * Cirrhosis * History of gastric or duodenal ulcers * Preoperative hypoalbuminemia (\<35 g/L) * History of severe renal, hepatic, cardiac or pulmonary disease * Past esophageal, gastric or bariatric surgery * Type 1 Diabetes * Pregnancy * Evidence of psychological problem that may affect the capacity to understand the project and to comply with the medical recommendations * History of drug use or alcohol abuse in the last 6 months * History of gastro-intestinal inflammatory diseases
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: Suzy Laroche
- Email: suzy_laroche@ssss.gouv.qc.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.
Conditions: Obesity, Morbid Obesity, bariatric surgery