Single Anastomosis Versus Standard Duodenal Switch
Recruiting now · Not applicable
Conditions studied: Obesity, Morbid Obesity
In brief
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.
Key facts
- Study ID
- NCT04767490
- Run by
- Laval University
- People needed
- 120
- Starts
- 2015-09-01
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2024-08-09
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years and ≤60 years
- Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35
- Give written informed consent
You may not qualify if…
- 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 it is running
- Institut Universitaire de Cardiologie et de Pneumologie de Québec — Québec, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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