Clinical Trial

Single Anastomosis Versus Standard Duodenal Switch

Study acronym: SADI
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated August 9, 2024 (before its estimated September 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2021-02-21.
Trial Details
NCT Number NCT04767490
Lead Sponsor Laval University
Collaborators: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Conditions Obesity, Morbid Obesity
Enrollment 120 participants
Start Date 2015-09-01
Primary Completion 2025-09-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2024-08-09