Clinical Trial

Standard Versus "Single Loop" Bypass After Parietal Gastrectomy

Active, Not Recruiting
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Summary
Bilio-pancreatic bypass (BPD-DS) is the most effective type of bariatric surgery in terms of weight loss and treatment of obesity-related comorbidities such as type 2 diabetes. Nevertheless, the spread of this procedure is limited by the technical difficulties and long-term nutritional complications inherent in this operation. Recently, a simplified "Duodenal Switch" technique has been proposed. This technique is known as "Single Anastomosis Duodeno-Ileal bypass" (SADI) and involves connecting the duodenum to the ileum, 250 cm upstream of the ileo-caecal valve, via an "omega" loop. This surgery is technically simpler and possibly less risky (particularly from a nutritional point of view) than the "standard" technique developed at the IUCPQ. This explains the enthusiasm in the surgical community for SADI, although the scientific evidence is very limited. The investigator has therefore initiated a prospective randomized study to compare standard bypass with single loop bypass as primary surgery. In this study, the investigator aims to evaluate the results of SADI versus standard bypass, as 2nd-stage surgery after parietal gastrectomy. The hypothesis is that SADI will be accompanied by fewer digestive and nutritional side effects, but also by a lower weight loss and a lower rate of recovery from comorbidities.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-04.
Trial Details
NCT Number NCT07115836
Lead Sponsor Laval University
Collaborators: Fondation de l'Institut universitaire de cardiologie et pneumologie de Québec
Conditions Obesity, Morbid, Obesity
Enrollment 63 participants
Start Date 2017-01-06
Primary Completion 2025-01-06 (estimated)
Study Completion 2028-01-06 (estimated)
Updated on ClinicalTrials.gov 2025-12-08