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

Rijnstate Hospital

Status: Completed

Conditions: Morbid Obesity

Treatments: Device: BRYGB

Study type: Interventional

Funder types: Other

Identifiers

NCT02545647

2015-0624

Details and patient eligibility

About

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.

Full 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)

Enrollment: 130 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Standard RYGB

No Intervention group

Description:

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

Banded RYGB

Active Comparator group

Description:

65 patients undergo a banded RYGB (BRYGB)

Treatment:

Device: BRYGB