Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)

Study Overview
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Brief Summary
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Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY). The aim of this novel study is to evaluate, if an additional restrictive silastic ring can avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive better postoperative weight loss and significantly improved long-term weight maintenance. The study will not investigate the GaBP-Ring as medical product but the effect of the GaBP-Ring on weight loss in comparison to gastric bypass alone.

Detailed Description
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GABY is designed as an international, multi center, open, prospective, randomized study to compare two methods of bariatric surgery: Banded versus conventional laparoscopic Roux-en-Y gastric bypass. At least 16 international high volume centres of excellence in bariatric surgery and at least 384 patients (24 patients at each center) in total will be included into this study. At least 320 patients must have completed the study after 5 years. Surgery will be performed according to standardized operating protocol. The group A (control group) will follow the worldwide golden standard of bariatric surgery (gastric bypass). Patients randomised to group B will receive in addition a restrictive silastic ring. The ring is a launched medical product and is registered in the European Community.

Official Title
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International, Multi Centre, Open, Prospective, Randomized Study: Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)

Conditions
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Morbid Obesity Requiring Bariatric Surgery

Intervention / Treatment
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* Procedure: Conventional laparoscopic Roux-en-Y gastric bypass
* Procedure: conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 40 kg /m2 to ≤ 50 kg/m2 Eating habit: sweet eater and volume eater Signed informed consent Patients with one or more of the following comorbidities: Hypertension, Diabetes mellitus Type 2, Hyperlipidemia, Hyperuricemia, Sleep apnea, Degenerative diseases of: Spine osteochondrosis, hip, knee, feet Exclusion Criteria: History of obesity surgery History of major abdominal surgery with consecutive malabsorption (no resections of the stomach, small and large bowel (exception: appendectomy) Patients not eligible to implement silastic ring size 6.5 cm History of drug or alcohol abuse History of major psychiatric illness conflicting with patient's compliance History of recent or chronic steroid medication Autoimmune disease Inflammatory bowel disease or malabsorptive disease Liver cirrhosis (CHILD B + C) Active viral or bacterial disease (e.g. HIV, Hepatitis B or C, Tbc etc.) Pregnant women or women with childbearing potential without efficient contraception History of cancer in the last five years Need of long-term anticoagulant medication for any reason Any medication with ingredient ASA

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 |
| --- | --- |
| Active Comparator: Group A<br>Conventional laparoscopic Roux-en-Y gastric bypass (Golden Standard) | Procedure: Conventional laparoscopic Roux-en-Y gastric bypass<br>* Conventional laparoscopic Roux-en-Y gastric bypass<br>|
| Experimental: Group B<br>Conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring | Procedure: conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring<br>* conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (GaBP-Ring)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative reduction of body mass index (BMI) and maintenance related to used bariatric procedure |  | 0, 3, 6, 12 months and 2, 3, 4, 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic, bariatric, surgery, obesity, Roux-en-Y, gastric, medical device, bypass, adiposity, GaBP-Ring, BMI, banded