The banded mini gastric bypass trial
Completed
- Conditions
- weight-loss surgery10017998
- Registration Number
- NL-OMON51858
- Lead Sponsor
- Ziekenhuisgroep Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>%TBWL after 5 years</p><br>
- Secondary Outcome Measures
Name Time Method <p>- (%EWL)<br /><br>- Decrease of comorbidities such as diabetes mellitus, hypertension, and<br /><br>hypercholesterolemia<br /><br>- Improvement of quality of life: SF-36 and OBESI-Q questionnaires<br /><br>- Incidence and severity of dumping syndrome<br /><br>-Incidence and severity of reflyx symptoms: GERD-HRQoL questionnaire<br /><br>- Incidence and complications due to silicone band</p><br>