To investigate the effect of variations in the length of bilipancreatic limb on weightreduction in morbidly obese patients undergoing RYGB-surgery.
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal therapeutic procedures
Synonym
Health condition
(morbide) obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Weight reduction; excess weight loss (%EWL).
Secondary outcome
a. Decrease in comorbidities: diabetes mellitus, hypertension,
hypercholesterolemia, artrosis
b. Quality of life: SF-36 and BAROS
c. Complicaties and re-operations: bleeding, woundinfections, intra-abdominal
abces, anastomosis leakage, vitamine definciencies
Background summary
Morbid obesity is an increasing medical problem in the western countries. It's
related to comorbidities as diabetes mellitus, hypertension, OSAS, artrosis and
hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective
surgical therapy for morbidly obese patients. A part of these patients will
have disappointing results, and have weight regain on the long term. Some
studies show more weight reduction by increasing the biliopancreatic limb in
patients with morbid obesity.
Study objective
To investigate the effect of variations in the length of bilipancreatic limb on
weightreduction in morbidly obese patients undergoing RYGB-surgery.
Study design
A prospective, single centre, randomized control trial
Intervention
Standard RYGB with biliopancreatic limb of 50 cm and Roux limb of 175 cm versus
Long biliopancreatic limb RYGB with biliopancreatic limb of 150 cm and Roux
limb of 50 cm.
Study burden and risks
The study will be a part of the regular medical care. There will be no extra
(invasive) research moments for particpating patients.
Wagnerlaan 55
Arnhem 6800TA
NL
Wagnerlaan 55
Arnhem 6800TA
NL
Listed location countries
Age
Inclusion criteria
- Patient eligible for bariatric surgery according Fried guidelines;Primary Gastric bypass
- BMI 35 - 40 with a comorbidity
- or BMI > 40;Redo- operation
- medical history: gastric sleeve/ mason / gastric band
- all BMI levels
Exclusion criteria
- Exclusion criteria for bariatric surgery (Fried Guidelines)
- Patients with language problems that intervens to follow medical advises
- Genetic diseases that intervens to follow medical advises
- Chronic bowel diseases
- Nefrologic (MDRD <30) of liver diseases (AST/ALT more than twice the norm)
- Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40139.091.12 |