Extended Pouch Roux-en-Y Gastric Bypass Study

Study Overview
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Brief Summary
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Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity. The objective of this study is to investigate the effect of a restrictive/extended pouch on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the restrictive/extended pouch results in more weight reduction. The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB.

Official Title
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Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a Prospective Randomized Control Trial

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Extended Pouch RYGB
* Procedure: Standard RYGB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient eligible for bariatric surgery according Fried guidelines Primary Gastric bypass BMI 35 - 40 with a comorbidity or BMI > 40 Exclusion Criteria: Exclusion criteria for bariatric surgery (Fried Guidelines) Patients with language problems that interveins to follow medical advises Genetic diseases that intervens to follow medical advises Chronic bowel diseases Nephrologic (MDRD <30) of liver diseases (AST/ALT more than twice the norm) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard RYGB<br>Standard RYGB | Procedure: Standard RYGB<br> <br> |
| Experimental: Extended Pouch RYGB<br>Restrictive/extended pouch RYGB | Procedure: Extended Pouch RYGB<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight reduction | Excess weight loss (%EWL) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in comorbidities | Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups: comorbidity resolved comorbidity improved comorbidity unchanged comorbidity worsened This will be done for diabetes mellitus, hypertension, dislipedimia and OSAS. | 2 years | 
| Change in comorbidities | Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups: comorbidity resolved comorbidity improved comorbidity unchanged comorbidity worsened This will be done for diabetes mellitus, hypertension, dislipidemia and OSAS. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery, Roux-en-Y Gastric Bypass