Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Biliopancreatic Diversion (BPD)- Duodenal Switch for Superobesity

Study Overview
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Brief Summary
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The purpose of this study is to compare the outcome in a broad perspective after laparoscopic Roux-en-Y gastric bypass and laparoscopic BPD-duodenal switch in the treatment of superobesity (body mass index [BMI] > 50 kg/m2).

Detailed Description
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Surgery is the only treatment of morbid obesity that has proven to result in efficient and long lasting weight loss. There are few studies comparing different surgical techniques, especially in a randomized setting. Superobesity (BMI > 50 kg/m2) demands an efficient surgical approach to result in satisfying weight loss. Laparoscopic techniques have been established to perform Roux-en-Y Gastric bypass and Biliopancreatic Diversion with Duodenal Switch which both are good options for treating superobesity. This study aims to compare the outcome after surgery in a broad perspective (weight loss, metabolic normalization, gastro-intestinal side effects, eating patterns, body composition, health economics). Patients will be randomized to either surgical procedure and will be followed for five years.

Official Title
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Laparoscopic Roux-en-Y Gastric Bypass vs. Laparoscopic BPD-Duodenal Switch for Superobesity (BMI > 50 kg/m2)- A Randomized Clinical Trial

Conditions
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Obesity, Diabetes, Hypertension

Intervention / Treatment
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* Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch
* Procedure: Laparoscopic Roux-en-Y Gastric Bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 50-60 kg/m2 Exclusion Criteria: Prior obesity operation Prior major abdominal surgical procedure Severe disabling cardiopulmonary disease Malignancy Oral steroid treatment Condition associated with poor compliance

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Laparoscopic Biliopancreatic diversion with Duodenal switch | Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch<br> <br> |
| Active Comparator: 2<br>Laparoscopic Roux-en-Y Gastric Bypass | Procedure: Laparoscopic Roux-en-Y Gastric Bypass<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | 5 y | 
| Metabolic normalization |  | 5y | 
| Gastro-intestinal side effects |  | 5y | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health economics |  | 5y | 
| Vitamin/mineral deficiencies |  | 5y | 
| Body composition |  | 5y | 
| Quality of life |  | 5y | 
| Eating pattern |  | 5y | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Surgery, Gastric bypass, Biliopancreatic diversion with Duodenal switch, Laparoscopy