Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities (Elegance)

Rijnstate Hospital

Status: Completed

Conditions: Morbid Obesity

Treatments: Procedure: Roux-en-Y Gastric Bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT01686997

Elegance01

Details and patient eligibility

About

Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity.

The objective of this study is to investigate the effect of variations in the length of biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that longer biliopancreatic limb results in more weight reduction.

The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (short biliopancreatic limb) and long biliopancreatic limb RYGB.

Enrollment: 280 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient eligible for bariatric surgery according Fried guidelines

Primary Gastric bypass

• BMI 35 - 40 with a comorbidity
• or BMI > 40

Redo- operation

• medical history: gastric sleeve/ mason / gastric band
• all BMI levels

Exclusion criteria

• Exclusion criteria for bariatric surgery (Fried Guidelines)
• Patients with language problems that interveins to follow medical advises
• Genetic diseases that intervens to follow medical advises
• Chronic bowel diseases
• Nephrologic (MDRD <30) of liver diseases (AST/ALT more than twice the norm)
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 4 patient groups

Primairy long biliopancreatic limb RYGB

Active Comparator group

Description:

Roux limb 75 cm and Biliopancreatic Limb 150 cm

Treatment:

Procedure: Roux-en-Y Gastric Bypass

Redo Long biliopancreatic limb RYGB

Active Comparator group

Description:

Roux limb 75 cm and Biliopancreatic limb 150 cm

Treatment:

Procedure: Roux-en-Y Gastric Bypass

Primairy standard RYGB

Active Comparator group

Description:

Roux limb 150 cm and Biliopancreatic limb 75 cm

Treatment:

Procedure: Roux-en-Y Gastric Bypass

Redo standard RYGB

Active Comparator group

Description:

Roux limb 150 cm and Biliopancreatic limb 75 cm

Treatment:

Procedure: Roux-en-Y Gastric Bypass