Clinical trial NCT01015469: Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)
Official title: International, Multi Centre, Open, Prospective, Randomized Study: Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Morbid Obesity Requiring Bariatric Surgery
Keywords: bariatric
surgery
obesity
Roux-en-Y
gastric
medical device
bypass
adiposity
GaBP-Ring
BMI
banded
laparoscopic
Lead sponsor: ClinTrio Ltd.
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: postoperative reduction of body mass index (BMI) and maintenance related to used bariatric procedure
timeFrame: 0, 3, 6, 12 months and 2, 3, 4, 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hallein
country: Austria
facility: Hospital Hallein (Scientific Review Board)
city: Brugge
country: Belgium
facility: Hospital AZ St.-Jan AV
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Berlin
country: Germany
facility: Privatpraxis Chirurgie bei Schlossparkklinik
city: Freiburg
country: Germany
facility: Albert-Ludwigs-University
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE)
city: München
country: Germany
facility: Chirurgische Klinik München-Bogenhausen GmbH
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
city: Heerlen
country: Netherlands
facility: Atruim Medical Centre
city: Lodz
country: Poland
facility: Medical University of Lodz
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Central
city: Santa Maria de Feira
country: Portugal
facility: Hospital de Sao Sebastiano
city: Jeddah
country: Saudi Arabia
facility: International Medical Center
Study officials:
affiliation: Albert-Ludwigs-University of Freiburg
name: Konrad W Karcz, MD
role: PRINCIPAL_INVESTIGATOR
References: