aparoscopic Sleeve Gastrectomy versus laparoscopic Roux-en-Y Gastric bypass trial for Morbid Obesity.
- Conditions
- obese weight100184241000301810017998morbid obesity
- Registration Number
- NL-OMON35688
- Lead Sponsor
- Sint Franciscus Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 750
• Age 18-60 years
• BMI> 40, or > 35 kg/m2 with pronounced co-morbidity, for more than 3 years
• Conservative therapy - preferably under the guidance of a physician or self help group - has failed or showed only transient results
• Psychological screening excluding psychiatric and psychological disorders
• Written informed consent and willing to enter the follow up program after surgery.
Prior bariatric surgery
• Prior major abdominal surgery (like colonic resection, septic abdomen, aorta surgery, which might jeopardise the technical feasibility of LSG or LRYGB)
• BMI > 60 kg/m2
• ASA (American Society for Anesthesiologists) classification >= IV
• Pregnant women
• Endocrine causes, alcohol or drug abuse
• Severe concomitant disease (carcinomas, neurodegenerative disorders or other disorders presently representing being considered exclusion criteria for bariatric surgery )
• The inability of reading/understanding and filling out questionnaires
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints: The primary and-point is %EWL at 5-years<br /><br>follow-up period. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary end-points are health related QOL, morbidity/mortality, readmission,<br /><br>reoperations, re-do surgery.</p><br>