Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Roux-en-Y Gastric Bypass

• Registration Number: NCT01686997
• Lead Sponsor: Rijnstate Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-18
• Primary Completion: 2016-01
• Study Completion: 2016-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-02
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primairy standard RYGB	Roux-en-Y Gastric Bypass	Roux limb 150 cm and Biliopancreatic limb 75 cm
Redo Long biliopancreatic limb RYGB	Roux-en-Y Gastric Bypass	Roux limb 75 cm and Biliopancreatic limb 150 cm
Redo standard RYGB	Roux-en-Y Gastric Bypass	Roux limb 150 cm and Biliopancreatic limb 75 cm
Primairy long biliopancreatic limb RYGB	Roux-en-Y Gastric Bypass	Roux limb 75 cm and Biliopancreatic Limb 150 cm

Primary Outcome Measures

Name	Time	Method
Weight reduction	2 years	excess weight loss (%EWL)

Secondary Outcome Measures

Name	Time	Method
Decrease in comorbidities	2 years	diabetes mellitus, hypertension, hypercholesterolemia, arthrosis
Quality of life	2 years	SF-36 and BAROS
Complications and re-operations	2 years	bleeding, wound infections, intra-abdominal abcess, anastomosis leakage, vitamine deficiencies

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands