Morbid Obesity Requiring Bariatric Surgery Clinical Trial
— GABYOfficial title:
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.
| Status | Recruiting |
| Enrollment | 384 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Hospital Hallein (Scientific Review Board) | Hallein | |
| Belgium | Hospital AZ St.-Jan AV | Brugge | |
| Belgium | AZ Sint-Blasius | Dendermonde | |
| Belgium | AZ Nikolaas | Sint-Niklaas | |
| Germany | Privatpraxis Chirurgie bei Schlossparkklinik | Berlin | |
| Germany | Albert-Ludwigs-University | Freiburg | |
| Germany | Universitätsklinikum Hamburg-Eppendorf (UKE) | Hamburg | |
| Germany | Chirurgische Klinik München-Bogenhausen GmbH | München | |
| Germany | Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH | Villingen-Schwenningen | |
| Netherlands | Atruim Medical Centre | Heerlen | |
| Poland | Medical University of Lodz | Lodz | |
| Portugal | Centro Hospitalar de Lisboa Central | Lisboa | |
| Portugal | Hospital de Sao Sebastiano | Santa Maria de Feira | |
| Saudi Arabia | International Medical Center | Jeddah |
| Lead Sponsor | Collaborator |
|---|---|
| ClinTrio Ltd. |
Austria, Belgium, Germany, Netherlands, Poland, Portugal, Saudi Arabia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | postoperative reduction of body mass index (BMI) and maintenance related to used bariatric procedure | 0, 3, 6, 12 months and 2, 3, 4, 5 years | No |