Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities

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 variations in the length of biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that longer biliopancreatic limb 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 (short biliopancreatic limb) and long biliopancreatic limb RYGB.

Official Title
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'Effect of Long biLiopancrEatic Limb lenGth in lAparoscopic Roux-eN-Y Gastric Bypass on Weight Loss and Comorbidities in Patients With Morbid obEsity: a Prospective Randomized Control Trial'

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Roux-en-Y Gastric Bypass


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 Redo- operation medical history: gastric sleeve/ mason / gastric band all BMI levels 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: Primairy long biliopancreatic limb RYGB<br>Roux limb 75 cm and Biliopancreatic Limb 150 cm | Procedure: Roux-en-Y Gastric Bypass<br> <br> |
| Active Comparator: Redo Long biliopancreatic limb RYGB<br>Roux limb 75 cm and Biliopancreatic limb 150 cm | Procedure: Roux-en-Y Gastric Bypass<br> <br> |
| Active Comparator: Primairy standard RYGB<br>Roux limb 150 cm and Biliopancreatic limb 75 cm | Procedure: Roux-en-Y Gastric Bypass<br> <br> |
| Active Comparator: Redo standard RYGB<br>Roux limb 150 cm and Biliopancreatic limb 75 cm | Procedure: 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 |
| --- | --- | --- |
| Weight reduction | excess weight loss (%EWL) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in comorbidities | diabetes mellitus, hypertension, hypercholesterolemia, arthrosis | 2 years | 
| Quality of life | SF-36 and BAROS | 2 years | 
| Complications and re-operations | bleeding, wound infections, intra-abdominal abcess, anastomosis leakage, vitamine deficiencies | 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