Rijnstate Hospital
Arnhem, 6800WC, Netherlands
NCT Number: NCT02545647
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Arnhem, 6800WC, Netherlands
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
65 patients undergo a banded RYGB
Other names: banded RYGB
Time frame: 3 years
weight loss is measured in kilogram.
Time frame: 3 years
excess weight loss is measured in kilogram.
Time frame: 3 years
Weight regain is measured in kilogram.
Time frame: 3 years
measuring glycated hemoglobin, decrease in diabetic medication
Time frame: 3 years
measuring BAROS score
Time frame: 3 years
decrease in medication for hypercholesterolaemie. Measuring cholesterol spectrum.
Time frame: 3 years
Measuring blood pressure
Rijnstate Hospital
Other
Banded Versus Non-banded Roux-en-y Gastric Bypass, a Randomised Controlled Trial
Acronym: Bandolera
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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