NCT04767490 Single Anastomosis Versus Standard Duodenal Switch
| NCT ID | NCT04767490 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laval University |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2015-09-01 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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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 120 participants in total. It began in 2015-09-01 with a primary completion date of 2025-09-01.
⚠ 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
Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS. The overall objective of this study is to assess in a prospective randomized blinded trial, the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.
Eligibility 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
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 NCT04767490 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 NCT04767490 currently recruiting?
Yes, NCT04767490 is actively recruiting participants. Contact the research team at suzy_laroche@ssss.gouv.qc.ca for enrollment information.
Where is the NCT04767490 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT04767490 clinical trial?
NCT04767490 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 120 participants.
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