Banded Versus Non-banded Roux-en-y Gastric Bypass (Bandolera)

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

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: Device: BRYGB

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Arnhem, Netherlands, 6800WC
    • Rijnstate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard RYGB; 65 patients undergo a standard Roux-en-Y gastric bypass
Active Comparator: Banded RYGB; 65 patients undergo a banded RYGB (BRYGB)	Device: BRYGB; 65 patients undergo a banded RYGB; Other Names: banded RYGB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage total body weight loss (%TBWL)	weight loss is measured in kilogram.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage excess weight loss (%EWL)	excess weight loss is measured in kilogram.	3 years
percentage total body weight regain (%TBWR)	Weight regain is measured in kilogram.	3 years
Decrease in type 2 diabetes mellitus	measuring glycated hemoglobin, decrease in diabetic medication	3 years
Quality of life	measuring BAROS score	3 years
Decrease in dyslipidaemia	decrease in medication for hypercholesterolaemie. Measuring cholesterol spectrum.	3 years
Decrease in hypertension	Measuring blood pressure	3 years

Collaborators and Investigators

• Sponsor: Rijnstate Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: September 7, 2015
• First Posted (Estimated): September 10, 2015

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 2015-0624