Banded Versus Non-banded Roux-en-y Gastric Bypass

Study Overview
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Brief Summary
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A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.

Detailed Description
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A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB. The Study design is a prospective, randomized, single center study. Study population: patients who qualify for a RYGB are eligible to participate. The primary RYGB patients may participate if there is a BMI of 35 kg / m2 with a morbidly obesity-related comorbidity or a BMI of 40kg / m2 or higher. Intervention: The standard RYGB with a vertical pouch over a 40 french feeding tube with a volume of 30-50 ml, is compared with a banded-RYGB (BRYGB)

Official Title
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Banded Versus Non-banded Roux-en-y Gastric Bypass, a Randomised Controlled Trial

Conditions
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Morbid Obesity

Intervention / Treatment
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* Device: BRYGB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients who are eligible for a primary RYGB Exclusion Criteria: Bariatric surgery in history Patients with a language barrier which may affect the compliance with medical advice Any kind of genetic disorders which can be of influence on the monitoring of medical advice Patients with a disease not related to morbid obesity, such as Cushing or drug related. Chronic bowel disease for example Crohn's disease or colitis Colitis. Renal impairment (MDRD <30) or hepatic dysfunction (liver function twice the normal values) Pregnancy Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard RYGB<br>65 patients undergo a standard Roux-en-Y gastric bypass | |
| Active Comparator: Banded RYGB<br>65 patients undergo a banded RYGB (BRYGB) | Device: BRYGB<br>* 65 patients undergo a banded RYGB<br>* Other names: banded RYGB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage total body weight loss (%TBWL) | weight loss is measured in kilogram. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage excess weight loss (%EWL) | excess weight loss is measured in kilogram. | 3 years | 
| percentage total body weight regain (%TBWR) | Weight regain is measured in kilogram. | 3 years | 
| Decrease in type 2 diabetes mellitus | measuring glycated hemoglobin, decrease in diabetic medication | 3 years | 
| Quality of life | measuring BAROS score | 3 years | 
| Decrease in dyslipidaemia | decrease in medication for hypercholesterolaemie. Measuring cholesterol spectrum. | 3 years | 
| Decrease in hypertension | Measuring blood pressure | 3 years |