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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01015469
Recruitment Status : Unknown
Verified February 2011 by ClinTrio Ltd..
Recruitment status was:  Recruiting
First Posted : November 18, 2009
Last Update Posted : February 17, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Requiring Bariatric Surgery Procedure: Conventional laparoscopic Roux-en-Y gastric bypass Procedure: conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International, Multi Centre, Open, Prospective, Randomized Study: Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)
Study Start Date : February 2009
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2015

Arm Intervention/treatment
Active Comparator: Group A
Conventional laparoscopic Roux-en-Y gastric bypass (Golden Standard)
Procedure: Conventional laparoscopic Roux-en-Y gastric bypass
Conventional laparoscopic Roux-en-Y gastric bypass

Experimental: Group B
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
conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (GaBP-Ring)

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01015469

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Contact: Burkhart Frankenberger +49-511-38814-0
Contact: Maria Noraman +49-511-38814-0

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Hospital Hallein (Scientific Review Board) Active, not recruiting
Hallein, Austria, 5400
Hospital AZ St.-Jan AV Recruiting
Brugge, Belgium, 8000
Contact: Bruno Dillemans, MD         
AZ Sint-Blasius Recruiting
Dendermonde, Belgium, 9200
Contact: Jaques Himpens, MD         
AZ Nikolaas Recruiting
Sint-Niklaas, Belgium, 9100
Contact: Luc Lemmens, MD         
Privatpraxis Chirurgie bei Schlossparkklinik Recruiting
Berlin, Germany, 14059
Contact: Volker Lange, Prof.         
Albert-Ludwigs-University Recruiting
Freiburg, Germany, 79106
Contact: Konrad W Karcz, MD         
Universitätsklinikum Hamburg-Eppendorf (UKE) Recruiting
Hamburg, Germany, 20246
Contact: Oliver Mann, MD         
Chirurgische Klinik München-Bogenhausen GmbH Recruiting
München, Germany, 81679
Contact: Günther Meyer, MD         
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Recruiting
Villingen-Schwenningen, Germany, 78011
Contact: Norbert Runkel, Prof.         
Atruim Medical Centre Recruiting
Heerlen, Netherlands, 6401
Contact: Jan W.M. Greve, MD         
Medical University of Lodz Recruiting
Lodz, Poland, 90-152
Contact: Tomasz Szewczyk, MD         
Centro Hospitalar de Lisboa Central Recruiting
Lisboa, Portugal, 1150-199
Contact: Rui Ribeiro, MD         
Hospital de Sao Sebastiano Recruiting
Santa Maria de Feira, Portugal, 4520-211
Contact: Mario Nora, MD         
Saudi Arabia
International Medical Center Recruiting
Jeddah, Saudi Arabia, 2172
Contact: Walid Bukhari, MD         
Sponsors and Collaborators
ClinTrio Ltd.
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Principal Investigator: Konrad W Karcz, MD Albert-Ludwigs-University of Freiburg

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Responsible Party: Burkhart Frankenberger - Director-, ClinTrio Ltd. Identifier: NCT01015469    
Other Study ID Numbers: IT5448081
EudraCT-No. 2009-016718-26
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: February 2011
Keywords provided by ClinTrio Ltd.:
medical device
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms