Morbid Obesity
Conditions
Brief summary
A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.
Detailed description
A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB. The Study design is a prospective, randomized, single center study. Study population: patients who qualify for a RYGB are eligible to participate. The primary RYGB patients may participate if there is a BMI of 35 kg / m2 with a morbidly obesity-related comorbidity or a BMI of 40kg / m2 or higher. Intervention: The standard RYGB with a vertical pouch over a 40 french feeding tube with a volume of 30-50 ml, is compared with a banded-RYGB (BRYGB)
Interventions
DEVICEBRYGB
65 patients undergo a banded RYGB
Sponsors
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* all patients who are eligible for a primary RYGB
Exclusion criteria
* Bariatric surgery in history * Patients with a language barrier which may affect the compliance with medical advice * Any kind of genetic disorders which can be of influence on the monitoring of medical advice * Patients with a disease not related to morbid obesity, such as Cushing or drug related. * Chronic bowel disease for example Crohn's disease or colitis Colitis. * Renal impairment (MDRD \<30) or hepatic dysfunction (liver function twice the normal values) * Pregnancy * Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage total body weight loss (%TBWL) | 3 years | weight loss is measured in kilogram. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage total body weight regain (%TBWR) | 3 years | Weight regain is measured in kilogram. |
| Decrease in type 2 diabetes mellitus | 3 years | measuring glycated hemoglobin, decrease in diabetic medication |
| Percentage excess weight loss (%EWL) | 3 years | excess weight loss is measured in kilogram. |
| Decrease in dyslipidaemia | 3 years | decrease in medication for hypercholesterolaemie. Measuring cholesterol spectrum. |
| Decrease in hypertension | 3 years | Measuring blood pressure |
| Quality of life | 3 years | measuring BAROS score |
Countries
Netherlands
Outcome results
None listed