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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
65 patients undergo a banded RYGB
Rijnstate Hospital
Arnhem, Netherlands
Percentage total body weight loss (%TBWL)
weight loss is measured in kilogram.
Time frame: 3 years
Percentage excess weight loss (%EWL)
excess weight loss is measured in kilogram.
Time frame: 3 years
percentage total body weight regain (%TBWR)
Weight regain is measured in kilogram.
Time frame: 3 years
Decrease in type 2 diabetes mellitus
measuring glycated hemoglobin, decrease in diabetic medication
Time frame: 3 years
Quality of life
measuring BAROS score
Time frame: 3 years
Decrease in dyslipidaemia
decrease in medication for hypercholesterolaemie. Measuring cholesterol spectrum.
Time frame: 3 years
Decrease in hypertension
Measuring blood pressure
Time frame: 3 years
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