The Sleeve versus Bypass trial
- Conditions
- <p>morbid obesity / morbiede obesitas bariatric surgery/ bariatrische chirurgie</p>Morbid obesity10017998
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 620
All morbidly obese patients who have been approved for bariatric surgery by the preoperative multidisciplinary team can be included in the sleeve versus bypass trial. Informed consent is mandatory. The criteria for bariatric surgery are age 18-60 years , BMI> 40, or > 35 kg/m2 with obesity-related-comorbidity (such as type 2 diabetes, hypertension, hypercholesterolemia, severe arthrosis and OSAS) for more than 3 years, conservative therapy (preferably under the guidance of a physician or self-help group) that has failed or showed only transient results, completion of psychological screening, excluding patients with psychiatric and psychological disorders, written informed consent and willingness to conclude the lifelong follow up program after surgery.
Exclusion criteria for this study are: diagnosed gastro oesophageal reflux disease (GERD) [16], severe sweet eating [17] prior bariatric surgery, prior major abdominal surgery (such as colonic resection, abdominal sepsis, aortic surgery, which might jeopardise the technical feasibility of LSG or LRYGB) and the inability of reading or understanding the questionnaires.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>Sustainable weight loss. The amount of weight loss is expressed as percentage excess weight loss (%EWL), and calculated with the formula %EWL = (pre-operative weight ¨C current weight) / (pre-operative weight- ideal weight) X 100%. For this formula a BMI of 25 kg/m2 was taken as the upper limit of normal, i.e. the ideal weight.</p><br>
- Secondary Outcome Measures
Name Time Method