OPTIMIZE-An observational study in morbidly obese patients to evaluate laparoscopic gastric sleeve resections an Roux-en-Y gastric bypass surgery in clinical and health-economic terms
- Conditions
- E66.82
- Registration Number
- DRKS00004182
- Lead Sponsor
- niversitätsklinikum Hamburg EppendorfKlinik für Allgemein-, Viszeral,- und Thoraxchirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 306
Inclusion Criteria
informed consent obtained
BMI > 40 or
BMI > 35 an the following co-morbidities
planned laparoscopic gastric sleeve resections or Roux-en-Y- bypass surgery
Insurance approval status: approved
Exclusion Criteria
BMI > 55
Patient has planned two-stage procedures
patient has prior bariatric procedures (including gastric-banding)
Patient has serious mental co-morbidities
Patient has serious physical comorbidities
insurance approval:rejected
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the curve of the quality of life (QOL) in the first post-operative year assessed by quality of life questionnaires (EQ-5D-5L),BAROS,M-A-QoLQ II, IWQOL- Lite)<br>Visits: Preoperative,Month 1, Month3, Month 6, Month 9, Month 12.
- Secondary Outcome Measures
Name Time Method Sec Outcome:<br>Excess weight loss in the first post operative year; changes in medication, changes in associated diseases, surgical complications Health resource utilization,Return to normal activity/functionality<br>Visits :Preoperative,Month 1, Month3, Month 6, Month 9, Month 12. <br>Methods: quality of life assessment questionnaires (s.a.), physical examination