aparoscopic Gastric Bypass: Common Channel trial

Recruiting

• Conditions: Morbid Obesity; 10018424; Overweight; 10003018; 10017998

• Registration Number: NL-OMON39011
• Lead Sponsor: Sint Franciscus Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 444

Inclusion Criteria

•Age 18-60 years
•BMI > 40, or >35 kg/m2 with co-morbidity
•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
•All patients with informed consent and willing to enter the follow up program after the operation.

Exclusion Criteria

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 1-year<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>