Single Anastomosis Versus Standard Duodenal Switch

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join if…

• 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

• Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, Quebec, Canada

Who to contact

Suzy Laroche · 418-656-8711 · suzy_laroche@ssss.gouv.qc.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04767490.