Single Anastomosis Versus Standard Duodenal Switch
Single Anastomosis Versus Standard Duodenal Switch - a Prospective Randomized Single-blinded Trial
Laval University
120 participants
Sep 1, 2015
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria13
- 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
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Interventions
Locations(1)
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NCT04767490