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

Not Applicable

Completed

• Conditions: Morbid Obesity

• Registration Number: NCT02545647
• Lead Sponsor: Rijnstate Hospital

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)

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-07
• Study First Posted: 2015-09-10
• Primary Completion: 2019-05
• Study Completion: 2023-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage total body weight loss (%TBWL)	3 years	weight loss is measured in kilogram.

Secondary Outcome Measures

Name	Time	Method
Percentage excess weight loss (%EWL)	3 years	excess weight loss is measured in kilogram.
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
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

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands