Duodenal Switch With a Standard Versus Long Alimentary Limb

Not Applicable

Completed

• Conditions: Bariatric Surgery Candidate; Obesity, Morbid; Metabolism Disorder
• Interventions: Procedure: Long alimentary limb BPD-DS

• Registration Number: NCT03097926
• Lead Sponsor: Laval University

Brief Summary

The aim of this study was to determine if Biliopancreatic Diversion with Duodenal Switch (BPD-DS) with a longer strict alimentary limb at the expense of a shorter biliopancreatic limb will offer significant weight lost, but with lesser gastrointestinal complaints, protein deficiency, vitamin and trace element deficit compared to standard BPD-DS.

Detailed Description

This two-group, randomized, single-blind pilot study is conducted in a university-affiliated tertiary care center. The study protocol was approved by our ethic committee. Enrollment and randomization of the patients occurred between May 20163 and June 2015. Patients are undergoing follow-up evaluation. Patients were initially referred to our center for a bariatric surgery evaluation. Eligible patients were 18 years of age or older and met the criteria for a laparoscopic biliopancreatic diversion. Patients were excluded if they had a BMI ≥ 50 mg/m², a pacemaker, cirrhosis or if they were planing pregnancy in the next 2 years. Each patient was required to provide written informed consent. Patients were randomly assigned in a 1:1 ratio to undergo a standard biliopancreatic diversion (control group) or a modified biliopancreatic diversion with a longer strict alimentary limb (study group). A sealed envelope with the assignation was given to the surgeon in the operation room just before the procedure. Patients are followed every 6 months after surgery, up to 24-months for clinical evaluation, resolution of comorbidities, evaluation of side-effects, quality of life, bioimpedance testing and bloodwork.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-03-26
• Study First Posted: 2017-03-31
• Status Verified: 2018-03
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-03-23
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Candidates for a biliopancreatic diversion, BMI above 35 with comorbidities or above 40 without comorbidities

Exclusion Criteria

• BMI ≥ 50 mg/m², pacemaker, cirrhosis or planning pregnancy in the next 2 years, hypoalbuminemia, irritable bowel syndrome.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard BPD-DS	Long alimentary limb BPD-DS	Standard BPD-DS with a 250-cm alimentary limb and 100-cm common channel
Long alimentary limb BPD-DS	Long alimentary limb BPD-DS	BPD-DS with a 100-cm common channel, a 100-cm biliary limb, the remaining bowel as the strict alimentary channel

Primary Outcome Measures

Name	Time	Method
Total weight change	6, 12, 18, 24 months	Changes in total body weight, in kg, from baseline

Secondary Outcome Measures

Name	Time	Method
Changes in Quality of life	6, 12, 18, 24 months	Measure of Quality of life using Short-Form 36
Changes in Gastro-intestinal side-effects scores	6,12,18,24 months	Gastro-intestinal symptoms assessed by measuring changes in GI Score