Single Anastomosis Versus Standard Duodenal Switch - a Prospective Randomized Single-blinded Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Age ≥18 years and ≤60 years

• Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35

• Give written informed consent

Locations
Other Locations
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
RECRUITING
Québec
Contact Information
Primary
Suzy Laroche
suzy_laroche@ssss.gouv.qc.ca
418-656-8711
Backup
Mélanie Nadeau, MSc
melanie.nadeau@criucpq.ulaval.ca
418-656-8711
Time Frame
Start Date: 2015-09-01
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 120
Treatments
Active_comparator: BPD-DS
Biliopancreatic diversion with Duodenal Switch (BPD-DS), with Sleeve gastrectomy, including a 100cm common channel and 150cm stric alimentary limb
Experimental: SADI
Single-Anastomosis Duodeno-Ileal anastomosis (SADI) with Sleeve Gastrectomy, including a 250cm common channel
Sponsors
Collaborators: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Leads: Laval University

This content was sourced from clinicaltrials.gov