- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01015469
Banded Versus Conventional Laparoscopic Roux-en-Y (GABY) (GABY)
International, Multi Centre, Open, Prospective, Randomized Study: Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Burkhart Frankenberger
- Phone Number: +49-511-38814-0
- Email: info@clintrio.com
Study Contact Backup
- Name: Maria Noraman
- Phone Number: +49-511-38814-0
- Email: m.noraman@clintrio.com
Study Locations
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Hallein, Austria, 5400
- Active, not recruiting
- Hospital Hallein (Scientific Review Board)
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Brugge, Belgium, 8000
- Recruiting
- Hospital AZ St.-Jan AV
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Contact:
- Bruno Dillemans, MD
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Dendermonde, Belgium, 9200
- Recruiting
- AZ Sint-Blasius
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Contact:
- Jaques Himpens, MD
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Sint-Niklaas, Belgium, 9100
- Recruiting
- AZ Nikolaas
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Contact:
- Luc Lemmens, MD
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Berlin, Germany, 14059
- Recruiting
- Privatpraxis Chirurgie bei Schlossparkklinik
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Contact:
- Volker Lange, Prof.
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Freiburg, Germany, 79106
- Recruiting
- Albert-Ludwigs-University
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Contact:
- Konrad W Karcz, MD
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Hamburg, Germany, 20246
- Recruiting
- Universitätsklinikum Hamburg-Eppendorf (UKE)
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München, Germany, 81679
- Recruiting
- Chirurgische Klinik München-Bogenhausen GmbH
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Villingen-Schwenningen, Germany, 78011
- Recruiting
- Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
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Contact:
- Norbert Runkel, Prof.
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Heerlen, Netherlands, 6401
- Recruiting
- Atruim Medical Centre
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Contact:
- Jan W.M. Greve, MD
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Lodz, Poland, 90-152
- Recruiting
- Medical University of Lodz
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Contact:
- Tomasz Szewczyk, MD
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Lisboa, Portugal, 1150-199
- Recruiting
- Centro Hospitalar de Lisboa Central
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Contact:
- Rui Ribeiro, MD
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Santa Maria de Feira, Portugal, 4520-211
- Recruiting
- Hospital de Sao Sebastiano
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Contact:
- Mario Nora, MD
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Jeddah, Saudi Arabia, 2172
- Recruiting
- International Medical Center
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Contact:
- Walid Bukhari, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Group A
Conventional laparoscopic Roux-en-Y gastric bypass (Golden Standard)
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Conventional laparoscopic Roux-en-Y gastric bypass
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Experimental: Group B
Conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring
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conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (GaBP-Ring)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postoperative reduction of body mass index (BMI) and maintenance related to used bariatric procedure
Time Frame: 0, 3, 6, 12 months and 2, 3, 4, 5 years
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0, 3, 6, 12 months and 2, 3, 4, 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Konrad W Karcz, MD, Albert-Ludwigs-University of Freiburg
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IT5448081
- EudraCT-No. 2009-016718-26
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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