Duodenal Switch With a Standard Versus Long Alimentary Limb

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomized Trial of Duodenal Switch With a Standard Versus Long Alimentary Limb.

Conditions
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Obesity, Morbid, Bariatric Surgery Candidate, Metabolism Disorder

Intervention / Treatment
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* Procedure: Long alimentary limb BPD-DS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard BPD-DS<br>Standard BPD-DS with a 250-cm alimentary limb and 100-cm common channel | Procedure: Long alimentary limb BPD-DS<br>* BPD-DS with a long strict alimentary limb and a 100-cm common channel.<br>|
| Experimental: Long alimentary limb BPD-DS<br>BPD-DS with a 100-cm common channel, a 100-cm biliary limb, the remaining bowel as the strict alimentary channel | Procedure: Long alimentary limb BPD-DS<br>* BPD-DS with a long strict alimentary limb and a 100-cm common channel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total weight change | Changes in total body weight, in kg, from baseline | 6, 12, 18, 24 months | 

Secondary Outcome Measures

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