Morbid Obesity, Weight Loss
Conditions
Keywords
gastric bypass, morbid obesity, gut function, weight loss
Brief summary
Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough for proper weight control. Bypassing a longer segment of the gut may be more beneficial. Which part to bypass is not clear. The investigators want to compare the effects between preventing a 60 cm proximal (oral) portion of the jejunum from food contact with the effects when preventing a 200 cm part of the jejunum from contact with bile and pancreatic juice. Endpoints are quality of life, gastrointestinal function, and weight development.
Detailed description
Two variations of gastric bypass are compared: Method 1 (test method):A 200 cm BP-limb (distance Treitz to EA) + 150 cm common channel (EA to ileocecal valve) + Roux-Y-limb variable Method 2 (standard method): A 60 cm BP limb + 150 cm Roux-Y-limb + common channel variable. Patients are evaluated according to the principles of the Scandinavian Obesity surgery registry (SOReg) with the addition of two additional questionnaires. FU time is set at 5 years.
Interventions
PROCEDUREgastric bypass
two techniques of gastric bypass for studying the effects of making a long BP-limb
Sponsors
Aleris Obesity
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Randomisation in the OR, (closed envelopes, blocks of six) no further info to ward or follow-up unit. No specific info as to randomisation outcome given to patients, all patients follow same protocol. Code number in operative charts.
Intervention model description
Randomised study between long and standard biliopancreatic limb in gstric bypass surgery
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* BMI 50-65 * Age 18-55 * Conservative attempts at weight reduction failed
Exclusion criteria
* Inability to speak and understand the Swedish language * Residence outside the county of Skåne * Psychotic disease * Inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| body weight reduction | 5 years | absolute BW reduction, percentage of patients reaching BMI below 30, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gastrointestinal function | 5 years | SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables |
Countries
Sweden
Outcome results
None listed