APAROSCOPIC GASTRIC BYPASS:Common Channel trial
- Conditions
- Morbid Obesity, Bariatric SurgeryMorbide Obesitas, Bariatrische chirurgie
- Registration Number
- NL-OMON24253
- Lead Sponsor
- G.H.H. Mannaerts, M.D., Ph.D. Gastrointestinal surgeonSint Franciscus Gasthuis Department of surgeryPO Box 3045 PMRotterdam, The NetherlandsT: +31-10-4616161 E: g.mannaerts@sfg.nl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 444
•Age 18-60 years
•BMI > 40, or >35 kg/m2 with co-morbidity
•Psychological screening excluding psychiatric and psychological disorders
•Informed consent and willing to enter the follow up program after the operation.
•Prior bariatric surgery
•Prior major abdominal surgery (like colonic resection, septic abdomen, aorta surgery, or other procedures with a high risk of intra-abdominal adhesions, which might jeopardise the possibility of performing a DLRYGB, standard LRYGB
•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
•DLRYGB or LYRGB is technically not possible as will be determined by the surgeon during surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is sustainable weight loss, which is expressed by the percentage Excess Weight Loss (%EWL) after a follow-up period of 1 year.<br>Excess weight (kg) will be calculated with the formula EW = AW-IW (actual weight- ideal weight), IW=22 x L2 (L=length in meters). The amount of weight loss will be expressed as percentage excess weight loss (%EWL), and calculated with the formula %EWL = (pre-operative BMI – current BMI) / (pre-operative BMI-25) X 100%.
- Secondary Outcome Measures
Name Time Method