Effects of Long Biliopancreatic Limb Versus Long Alimentary Limb in Superobesity, a Randomized Study
- Conditions
- Severe Obesity
- Registration Number
- NCT02033577
- Lead Sponsor
- Aleris Obesity
- Brief Summary
Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different.
Study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.
- Detailed Description
Randomisation in the OR between long biliopancreatic limb and long alimentary limb. GAstric component identical.
Perioperative biopsies to assess mucosal properties at the gastrojejunostomy and the enteroanastomosis. Repeat biopsies (gastroscopy) at one year to identify changes in the mucosa at the Gastroenteroanastomosis.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- BMI > 50
- Psychiatric disease
- Inflammatory bowel disease
- inability to understand Swedish
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Body weight reduction 2 years from end of inclusion Body weight reduction is currently the best substitute endpoint to correlate with the hard endpopints such as death, comorbidities etc.
- Secondary Outcome Measures
Name Time Method Patient assessed quality of life 2 years from end of inclusion We employ SF-36, Op-9, GSRS, TFEQ scales
Trial Locations
- Locations (1)
Aleris Obesity
🇸🇪Lund, Sweden
Aleris Obesity🇸🇪Lund, SwedenBent Johnny Nergaard, MDSub InvestigatorJan HedenbroContact