NCT02545647

Banded Versus Non-banded Roux-en-y Gastric Bypass

Banded Versus Non-banded Roux-en-y Gastric Bypass, a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Rijnstate Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
DEVICE	BRYGB	65 patients undergo a banded RYGB

Timeline

• Start date: 2015-08-01
• Primary completion: 2019-05-01
• Completion: 2023-05-01
• First posted: 2015-09-10
• Last updated: 2024-06-21

Locations

1 site across 1 country: Netherlands