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

Morbid Obesity Clinical Trial

— Bandolera  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02545647
• Other study ID #: 2015-0624
• Status: Active, not recruiting
• Phase: N/A
• First received: September 3, 2015
• Last updated: June 30, 2016
• Start date: September 2015
• Est. completion date: September 2019

Study information

• Verified date: June 2016
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: September 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Device:
• BRYGB
65 patients undergo a banded RYGB

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage total body weight loss (%TBWL)	weight loss is measured in kilogram.	3 years	No
Secondary	Percentage excess weight loss (%EWL)	excess weight loss is measured in kilogram.	3 years	No
Secondary	percentage total body weight regain (%TBWR)	Weight regain is measured in kilogram.	3 years	No
Secondary	Decrease in type 2 diabetes mellitus	measuring glycated hemoglobin, decrease in diabetic medication	3 years	No
Secondary	Quality of life	measuring BAROS score	3 years	No
Secondary	Decrease in dyslipidaemia	decrease in medication for hypercholesterolaemie. Measuring cholesterol spectrum.	3 years	No
Secondary	Decrease in hypertension	Measuring blood pressure	3 years	No