Clinical trial NCT02545647: Banded Versus Non-banded Roux-en-y Gastric Bypass
Official title: Banded Versus Non-banded Roux-en-y Gastric Bypass, a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Percentage total body weight loss (%TBWL)
timeFrame: 3 years
Secondary outcomes:
measure: Percentage excess weight loss (%EWL)
timeFrame: 3 years
measure: percentage total body weight regain (%TBWR)
timeFrame: 3 years
measure: Decrease in type 2 diabetes mellitus
timeFrame: 3 years
measure: Quality of life
timeFrame: 3 years
measure: Decrease in dyslipidaemia
timeFrame: 3 years
measure: Decrease in hypertension
timeFrame: 3 years
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
References: