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

February 16, 2011 updated by: ClinTrio Ltd.

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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

384

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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)

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
0, 3, 6, 12 months and 2, 3, 4, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ClinTrio Ltd.

Investigators

  • Principal Investigator: Konrad W Karcz, MD, Albert-Ludwigs-University of Freiburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Estimate)

February 17, 2011

Last Update Submitted That Met QC Criteria

February 16, 2011

Last Verified

February 1, 2011

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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