Duodenal Switch With a Standard Versus Long Alimentary Limb (Long_limb_DS)

Laval University

Status: Completed

Conditions: Bariatric Surgery Candidate; Obesity, Morbid; Metabolism Disorder

Treatments: Procedure: Long alimentary limb BPD-DS

Study type: Interventional

Funder types: Other

Identifiers

NCT03097926

DS long Limb

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Standard BPD-DS

Active Comparator group

Description:

Standard BPD-DS with a 250-cm alimentary limb and 100-cm common channel

Treatment:

Procedure: Long alimentary limb BPD-DS

Long alimentary limb BPD-DS

Experimental group

Description:

BPD-DS with a 100-cm common channel, a 100-cm biliary limb, the remaining bowel as the strict alimentary channel

Treatment:

Procedure: Long alimentary limb BPD-DS