Skip to content

Laparoscopic Sleeve Gastrectomy versus laparoscopic Roux-en-Y Gastric bypass trial for Morbid Obesity.

Laparoscopic Sleeve Gastrectomy versus laparoscopic Roux-en-Y Gastric bypass trial for Morbid Obesity. - sleeve versus bypass trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35688
Enrollment
750
Registered
2012-07-03
Start date
2012-11-15
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

morbid obesity obese weight

Interventions

Intervention: LSG Control: LRYGB

Sponsors

Sint Franciscus Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: The primary and-point is %EWL at 5-years follow-up period.

Secondary

MeasureTime frame
Secondary end-points are health related QOL, morbidity/mortality, readmission, reoperations, re-do surgery.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)