Morbid obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Age 18-65 Years - BMI * 35 with co-morbidity or BMI * 40 - Signed informed consent - Approval by the multidisciplinary team
Exclusion criteria
Exclusion criteria: -History of obesity surgery -History of major abdominal surgery with consecutive malabsorption (no restrictions of the stomach, small and large bowel (exception appendectomy) -Patients not eligible to implement the adjustable band - History of/or present alcohol or drug abuse - History of major psychiatric illness conflicting with the patient compliance - History of recent or chronic steroid medication - Autoimmune disease - Inflammatory bowel disease or malabsorptive disease - Liver cirrhosis (CHILD B + C) - Active viral or bacterial disease (HIV, Hepetitis B or C, Tbc etc) - Pregnancy - History of cancer in the last 5 years - Need of long term anticoagulant medication for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: similar or less complication rate of short term complications of a standard Roux- and Y gastric bypass and similar or less percentages of band erosion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: similar or more excess weight loss compared to RYGB. | — |
Countries
Netherlands