This study will evaluate the effectiveness and safety of the use of the gastric ring in preventing weight increase after 2 years
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bodyweight measured as BMI
Secondary outcome
Safety of the gastric ring
Background summary
Up to now no multicentre comparative study between banded and conventional
gastric bypass has been performed.
The GABY study is designed as an international, multicentre, open, prospective,
randomized study to compare two methods of bariatric surgery: Banded versus
conventional laparoscopic Roux-en-Y gastric bypass.
At least 16 international centres of exellence in bariatric surgery will
include at least 384 patients. At least 320 patients must have completed the
study after 5 years.
Surgery will be performed according to a standardized operating protocol. The
controlgroup will follow the worldwide golden standard of bariatric surgery:
gastric bypass. Patients randomized 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 and will be distributed to each centre.
All patients will be treated as under the normal bariatric surgical conditions.
No additional risks are expected for those patients receiving the silastic
ring.
Study objective
This study will evaluate the effectiveness and safety of the use of the gastric
ring in preventing weight increase after 2 years
Study design
Open, randomized
Intervention
Placement of the silastic ring
Study burden and risks
There are no serious side effects known from the silastic gastric ring
Davenstedter Str. 60
30453 Hannover
DE
Davenstedter Str. 60
30453 Hannover
DE
Listed location countries
Age
Inclusion criteria
Age 18-60
BMI >39-50
Signed informed consent
Volume eater / sweet eater
Exclusion criteria
History of obesity surgery
History of major abdominal surgery
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27562.096.09 |