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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2011 by ClinTrio Ltd.
Sponsor:
Information provided by:
ClinTrio Ltd.
ClinicalTrials.gov Identifier:
NCT01015469
First received: November 17, 2009
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: International, Multi Centre, Open, Prospective, Randomized Study: Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)

Resource links provided by NLM:


Further study details as provided by ClinTrio Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 384
Study Start Date: February 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015469

Contacts
Contact: Burkhart Frankenberger +49-511-38814-0 info@clintrio.com
Contact: Maria Noraman +49-511-38814-0 m.noraman@clintrio.com

Locations
Austria
Hospital Hallein (Scientific Review Board) Active, not recruiting
Hallein, Austria, 5400
Belgium
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         
Germany
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.         
Netherlands
Atruim Medical Centre Recruiting
Heerlen, Netherlands, 6401
Contact: Jan W.M. Greve, MD         
Poland
Medical University of Lodz Recruiting
Lodz, Poland, 90-152
Contact: Tomasz Szewczyk, MD         
Portugal
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.
Investigators
Principal Investigator: Konrad W Karcz, MD Albert-Ludwigs-University of Freiburg
  More Information

No publications provided

Responsible Party: Burkhart Frankenberger - Director-, ClinTrio Ltd.
ClinicalTrials.gov Identifier: NCT01015469     History of Changes
Other Study ID Numbers: IT5448081, EudraCT-No. 2009-016718-26
Study First Received: November 17, 2009
Last Updated: February 16, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ClinTrio Ltd.:
bariatric
surgery
obesity
Roux-en-Y
gastric
medical device
bypass
adiposity
GaBP-Ring
BMI
banded
laparoscopic

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014