To investigate the effect of variations in the pouch shape and size in RYGB on weightreduction.
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; total body weight loss (%TBWL) and excess weight loss (%EWL)
Secondary outcome
a. decrease in comorbidities: diabetes mellitus, hypertension,
hypercholesterolemia, artrosis
b. quality of life: SF-36 and BAROS
c. Complications and re-operations: bleeding, woundinfections, intra-abdominal
abces, anastomotic leakage, vitamin deficiencies, reflux
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-and-Y Gastric Bypass (RYGB) is an effective
surgical therapy for morbidly obese patients. A part of these patientes will
have disappointing result, and have weight regain on the long term. Some
studies show more weight reduction by changing the shape of the pouch.
Study objective
To investigate the effect of variations in the pouch shape and size in RYGB on
weightreduction.
Study design
A prospective, single centre, randomized control trial
Intervention
Standard RYGB with a 40-50cc pouch versus an extended pouch in RYGB.
Study burden and risks
the study will be a part of the regular medical care. There will be no extra
(invasive) research moments for participating patients; only questionnairies.
Wagnerlaan 55
Arnhem 6800TA
NL
Wagnerlaan 55
Arnhem 6800TA
NL
Listed location countries
Age
Inclusion criteria
- Age between 18 and 60 years
- BMI >40 kg/m2 without comorbidities
- BMI >35 and <40 kg/m2 with comorbidities of which expect to be improve after surgery
- Medical history of overweight for atleast 5 years
- Proven failed attempts to lose weight in a conservative way, or initial good result with relapse in weight
- The intention to fully follow the postoperative program
Exclusion criteria
- Mental disorder, psychotic disorders, severe depression and personality disorders
- Never had professional medical guidance with weight loss
- Not able to participate in long-term medical checks
- Alcohol or drug abuse
- Diseases that form a threat on life expectancy on the short term of perioperative
- Patients who can not take care for themselfs, or pateint who do not have any social network to take this responsibility
- Bariatric surgery in the medical history
- Patients with a language barrier which can have affect on medical follow up and treatment
- Any kind of genetic disorders which can be of influence on medical advice
- Patients with a disease not related to morbid obesity , eg Cushing or medication related
- Chronic bowel diseases; eg M. Crohn or Colitis Collitis
- Renal impairment ( MDRD < 30 ) or hepatic dysfunction ( ASAT / ALAT twice the normal values)
- Pregnancy
- Patients with therapy-resistant reflux symptoms. Defined as persistent symptoms despite the use of maxiaml dosage proton-pump-inhibitors (PPI) ( Pantozol 2d40mg/Omeprazol 2d40mg )
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 | NL46852.091.13 |