To investigate the effect of a banded-extended RYGB on weightloss and weigtregain on the long term.
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
Weightregain after three years
Total body Weight Loss (%TBWL)
Secondary outcome
- Weight reduction; percentage Excess Weight Loss (%EWL) en Excess Body Mass
Index Loss (%EBMIL)
- Complications and reoperations; eg bleeding, wound infections,
intra-abdominal abcess, anastomotic leakage, vitamin deficiencies
- Reduction of comorbidities; type 2 diabetes, hypertension,
hypercholesterolemia, artrosis, Obstructive Sleep Apnoea Syndrome (OSAS)
- Quality of life; BAROS and SF-36, food tolerance
- Length common channel
- Defecation pattern
- Reflux
Background summary
The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for
morbid obesity by reducing weight and comorbidities. Extending the pouch may
improve weightloss without the increase of complications. Some patients regain
weight after initiale good weightloss after RYGB. Placing a minimizer around
the pouch may prevent this weighregain.
Study objective
To investigate the effect of a banded-extended RYGB on weightloss and
weigtregain on the long term.
Study design
A prospective, single center, randomized controlled study
Intervention
The standard RYGB versus extended pouch RYGB vs banded-extended RYGB.
Study burden and risks
Possible disadvantages of the Banded-extended-RYGB compared to the S-RYGB
- Sometimes removal of the band can be nessecary due to erosion or displacement.
- Reflux
- Dysphagia
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
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 improve after
surgery
- Medical history of overweight for atleast 5 years
- Proven failed attempts to lose weight in a conservative way, or initial goed
result with relapse
- 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
- Pregnacy
- Bariatric surgery in the medical history
- Patients with a language barrier which can have affect on medical follow up
and treatment
- 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)
- 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 | NL62168.091.17 |