The main objective is the %TBWL 5 years after surgery. Secondary objectives include Percentage Excess Weight Loss (%EWL); decrease of comorbidities such as diabetes mellitus (DM), hypertension, and hypercholesterolemia; improvement of quality of…
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
%TBWL after 5 years
Secondary outcome
- (%EWL)
- Decrease of comorbidities such as diabetes mellitus, hypertension, and
hypercholesterolemia
- Improvement of quality of life: SF-36 and OBESI-Q questionnaires
- Incidence and severity of dumping syndrome
-Incidence and severity of reflyx symptoms: GERD-HRQoL questionnaire
- Incidence and complications due to silicone band
Background summary
Zie K1
Study objective
The main objective is the %TBWL 5 years after surgery. Secondary objectives
include Percentage Excess Weight Loss (%EWL); decrease of comorbidities such as
diabetes mellitus (DM), hypertension, and hypercholesterolemia; improvement of
quality of life: incidence and severity of dumping syndrome; incidence and
severity of reflux symptoms; incidence and complications due to band
application.
Study design
A prospective randomized controlled trial
Intervention
One group receives *standard* Omega Loop Gastric Bypass (OLGB) and one group
receives banded OLGB (bOLGB), which means adjustment of a MiniMizer Ring around
the gastric pouch.
Study burden and risks
Expected advantages of bOLGB versus OLGB:
1. Increase of weight reduction, and due to that decrease of
comorbidities and/or
mortality due to overweight.
2. Long term decrease of weight regain.
3. Decrease of incidence of dumping.
Possible disadvantages of bOLGB versus OLGB:
1. Band-related complications such as erosion, infection, stenosis, or
pouch dilatation.
2. Functional gastro-intestinal complains such as dysphagia and reflux.
Zilvermeeuw 1
Almelo 7609PP
NL
Zilvermeeuw 1
Almelo 7609PP
NL
Listed location countries
Age
Inclusion criteria
Patients who are eligible for OLGB surgery will be included for this study
according the national guidelines for bariatric surgery.
Exclusion criteria
- Bariatric surgery in the past
- Patients
- Chronical inflammatoiry diseases
- Kidney- or liver dysfunction
- Pregnancy at the start or during the experiment
- Patients with therapeutic resistance in severe clinical complains of reflux
- Allergie for silicone
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 | NL80550.100.22 |