Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)
NCT ID: NCT01015469
Last Updated: 2011-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
384 participants
INTERVENTIONAL
2009-02-28
2015-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Conventional laparoscopic Roux-en-Y gastric bypass (Golden Standard)
Conventional laparoscopic Roux-en-Y gastric bypass
Conventional laparoscopic Roux-en-Y gastric bypass
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
conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (GaBP-Ring)
Interventions
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Conventional laparoscopic Roux-en-Y gastric bypass
Conventional laparoscopic Roux-en-Y gastric bypass
conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring
conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (GaBP-Ring)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
60 Years
ALL
No
Sponsors
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ClinTrio Ltd.
OTHER
Responsible Party
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ClinTrio Ltd.
Principal Investigators
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Konrad W Karcz, MD
Role: PRINCIPAL_INVESTIGATOR
Albert-Ludwigs-University of Freiburg
Locations
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Hospital Hallein (Scientific Review Board)
Hallein, , Austria
Hospital AZ St.-Jan AV
Bruges, , Belgium
AZ Sint-Blasius
Dendermonde, , Belgium
AZ Nikolaas
Sint-Niklaas, , Belgium
Privatpraxis Chirurgie bei Schlossparkklinik
Berlin, , Germany
Albert-Ludwigs-University
Freiburg im Breisgau, , Germany
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, , Germany
Chirurgische Klinik München-Bogenhausen GmbH
München, , Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, , Germany
Atruim Medical Centre
Heerlen, , Netherlands
Medical University of Lodz
Lodz, , Poland
Centro Hospitalar de Lisboa Central
Lisbon, , Portugal
Hospital de Sao Sebastiano
Santa Maria de Feira, , Portugal
International Medical Center
Jeddah, , Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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Bruno Dillemans, MD
Role: primary
Jaques Himpens, MD
Role: primary
Luc Lemmens, MD
Role: primary
Volker Lange, Prof.
Role: primary
Konrad W Karcz, MD
Role: primary
Oliver Mann, MD
Role: primary
Günther Meyer, MD
Role: primary
Norbert Runkel, Prof.
Role: primary
Jan W.M. Greve, MD
Role: primary
Tomasz Szewczyk, MD
Role: primary
Rui Ribeiro, MD
Role: primary
Mario Nora, MD
Role: primary
Walid Bukhari, MD
Role: primary
Other Identifiers
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EudraCT-No. 2009-016718-26
Identifier Type: -
Identifier Source: secondary_id
IT5448081
Identifier Type: -
Identifier Source: org_study_id
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