Overview

This trial is active, not recruiting.

Condition morbid obesity
Treatment brygb
Sponsor Rijnstate Hospital
Start date September 2015
End date September 2018
Trial size 130 participants
Trial identifier NCT02545647, 2015-0624

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
65 patients undergo a standard Roux-en-Y gastric bypass
(Active Comparator)
65 patients undergo a banded RYGB (BRYGB)
brygb banded RYGB
65 patients undergo a banded RYGB

Primary Outcomes

Measure
Percentage total body weight loss (%TBWL)
time frame: 3 years

Secondary Outcomes

Measure
Percentage excess weight loss (%EWL)
time frame: 3 years
percentage total body weight regain (%TBWR)
time frame: 3 years
Decrease in type 2 diabetes mellitus
time frame: 3 years
Quality of life
time frame: 3 years
Decrease in dyslipidaemia
time frame: 3 years
Decrease in hypertension
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Banded Versus Non-banded Roux-en-y Gastric Bypass, a Randomised Controlled Trial
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)
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Rijnstate Hospital.