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

Phase 4

• Conditions: Morbid Obesity Requiring Bariatric Surgery
• Interventions: Procedure: Conventional laparoscopic Roux-en-Y gastric bypass; Procedure: conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring

• Registration Number: NCT01015469
• Lead Sponsor: ClinTrio Ltd.

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-17
• Study First Posted: 2009-11-18
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-16
• Last Update Posted: 2011-02-17
• Primary Completion: 2014-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 384

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Conventional laparoscopic Roux-en-Y gastric bypass	Conventional laparoscopic Roux-en-Y gastric bypass (Golden Standard)
Group B	conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring	Conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (14)

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Belgium

Hospital AZ St.-Jan AV; 🇧🇪 Brugge, Belgium

Atruim Medical Centre; 🇳🇱 Heerlen, Netherlands

Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH; 🇩🇪 Villingen-Schwenningen, Germany

Hospital de Sao Sebastiano; 🇵🇹 Santa Maria de Feira, Portugal

Privatpraxis Chirurgie bei Schlossparkklinik; 🇩🇪 Berlin, Germany

AZ Sint-Blasius; 🇧🇪 Dendermonde, Belgium

Albert-Ludwigs-University; 🇩🇪 Freiburg, Germany

Chirurgische Klinik München-Bogenhausen GmbH; 🇩🇪 München, Germany

Medical University of Lodz; 🇵🇱 Lodz, Poland

Centro Hospitalar de Lisboa Central; 🇵🇹 Lisboa, Portugal

Universitätsklinikum Hamburg-Eppendorf (UKE); 🇩🇪 Hamburg, Germany

International Medical Center; 🇸🇦 Jeddah, Saudi Arabia

Hospital Hallein (Scientific Review Board); 🇦🇹 Hallein, Austria