To research in three groups whether there is a significant difference between RYGB and BRYGB patients.
ID
Source
Brief title
Condition
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage Total Body Weight Loss (%TBWL) after three years.
Secondary outcome
a. Percentage Excess Weight Loss (%EWL), and Body Mass Index (BMI)
b. Percentage total body weight regain
c. Reduction of co-morbidities due to morbid obesity
d. Quality of life: SF-36 en BAROS
e. Incidence of dumping syndrome
f. Difference in complication rates
g. Differences between the two devices: all endpoints written above, operating
time and complications, implantation time and the costs.
Background summary
Morbid Obesity has become a worldwide health problem. Especially the related
co-morbidities like type II diabetes mellitus, hypertension and sleep apnea
syndrome, artrosis and dyslipidemia lead not only to an increased morbidity but
also to an increased mortality. The Roux-en-Y Gastric Bypass (RYGB) has proven
itself as an effective treatment for morbid obesity in the long term.
Unfortunately not all patients prosper with a RYGB, while a number of patients
seem to regain weight after a few years. Recently published literature shows
that adding a small silicone band to the RYGB might lead to increased weight
loss and less weight regain in the long term (Banded RYGB or BRYGB). Two types
of silicone bands are currently available: the GaPB ring and the Minimizer
ring.
This study researches whether placing a silicone band around a primary
performed RYGB indeed leads to increased weight loss and less weight regain.
Also we want to research whether there is a difference between the two types of
silicone bands available.
Study objective
To research in three groups whether there is a significant difference between
RYGB and BRYGB patients.
Study design
Randomized controlled, single centre trial. 130 Patients will be randomized in
2 different groups: the standard Roux-en-Y gastric bypass and the banded
gastric bypass with minimizer ring.
Intervention
Group 1:The RYGB is created with a vertical pouch using a 40fr gastric tube
(volume 30-50ml), an biliopancreatic limb of 75 cm and alimentary limb of
150cm. Group 2: Same procedure as group 1 adding the Minimizer ring.
Study burden and risks
Ring-related disadventages in comparison with the standard Roux-en-Y gastric
bypass:
- erosion, migration, infection, stenosis
- dysfagia and reflux
All patients who participate the study will be asked to fill in 2 questionairs
before every visit at the outpatient department: BAROS, SF-36 and GERD-HRQL
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
Fried Guidelines for bariatric surgery:;- age between 18-65 year
- BMI >40 kg/m2 without comorbidities
- BMI > 35 and <40 kg/m2 with obesity related comorbidities
- At least 5 years of overweight
- Proved failed conservative treatments for obesity
- Good motivation to follow the postoperative program
Exclusion criteria
- Fried Guidelines for bariatric surgery
- Specific exclusion criteria for this study: previous bariatric surgery, language barrier, genetic disorder which influences medical advice, patients with obesity due to an other disease e.g. Cushing or medication. Chronic bowel disease e.g. M. Crohn or collitis ulcerosa. Renal failure (MDRD<30) or liver function disorder (ASAT/ALAT twice the normal range). Pregnancy. Patients with therapy-resistancy for refluxdisease, despite the use of proton pomp inhibitors (omeprazol 2 times a day 40mg).
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 | NL51242.091.14 |