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

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
BRYGB
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rijnstate Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard RYGB

Banded RYGB

Arm Description

65 patients undergo a standard Roux-en-Y gastric bypass

65 patients undergo a banded RYGB (BRYGB)

Outcomes

Primary Outcome Measures

Percentage total body weight loss (%TBWL)
weight loss is measured in kilogram.

Secondary Outcome Measures

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

Full Information

First Posted
September 3, 2015
Last Updated
June 30, 2016
Sponsor
Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02545647
Brief Title
Banded Versus Non-banded Roux-en-y Gastric Bypass
Acronym
Bandolera
Official Title
Banded Versus Non-banded Roux-en-y Gastric Bypass, a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard RYGB
Arm Type
No Intervention
Arm Description
65 patients undergo a standard Roux-en-Y gastric bypass
Arm Title
Banded RYGB
Arm Type
Active Comparator
Arm Description
65 patients undergo a banded RYGB (BRYGB)
Intervention Type
Device
Intervention Name(s)
BRYGB
Other Intervention Name(s)
banded RYGB
Intervention Description
65 patients undergo a banded RYGB
Primary Outcome Measure Information:
Title
Percentage total body weight loss (%TBWL)
Description
weight loss is measured in kilogram.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Percentage excess weight loss (%EWL)
Description
excess weight loss is measured in kilogram.
Time Frame
3 years
Title
percentage total body weight regain (%TBWR)
Description
Weight regain is measured in kilogram.
Time Frame
3 years
Title
Decrease in type 2 diabetes mellitus
Description
measuring glycated hemoglobin, decrease in diabetic medication
Time Frame
3 years
Title
Quality of life
Description
measuring BAROS score
Time Frame
3 years
Title
Decrease in dyslipidaemia
Description
decrease in medication for hypercholesterolaemie. Measuring cholesterol spectrum.
Time Frame
3 years
Title
Decrease in hypertension
Description
Measuring blood pressure
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
ZIP/Postal Code
6800WC
Country
Netherlands

12. IPD Sharing Statement

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

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