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

This study is currently recruiting participants.
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

November 17, 2009
February 16, 2011
February 2009
March 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01015469 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Banded Versus Conventional Laparoscopic Roux-en-Y (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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Morbid Obesity Requiring Bariatric Surgery
  • Procedure: Conventional laparoscopic Roux-en-Y gastric bypass
    Conventional laparoscopic Roux-en-Y gastric bypass
  • 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)
  • Active Comparator: Group A
    Conventional laparoscopic Roux-en-Y gastric bypass (Golden Standard)
    Intervention: Procedure: Conventional laparoscopic Roux-en-Y gastric bypass
  • Experimental: Group B
    Conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring
    Intervention: Procedure: conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
384
March 2015
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Burkhart Frankenberger +49-511-38814-0 info@clintrio.com
Contact: Maria Noraman +49-511-38814-0 m.noraman@clintrio.com
Austria,   Belgium,   Germany,   Netherlands,   Poland,   Portugal,   Saudi Arabia
 
NCT01015469
IT5448081, EudraCT-No. 2009-016718-26
No
Burkhart Frankenberger - Director-, ClinTrio Ltd.
ClinTrio Ltd.
Not Provided
Principal Investigator: Konrad W Karcz, MD Albert-Ludwigs-University of Freiburg
ClinTrio Ltd.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP