Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities

Morbid Obesity Clinical Trial

— Elegance  

Official title:

'Effect of Long biLiopancrEatic Limb lenGth in lAparoscopic Roux-eN-Y Gastric Bypass on Weight Loss and Comorbidities in Patients With Morbid obEsity: a Prospective Randomized Control Trial'

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686997
• Other study ID #: Elegance01
• Status: Completed
• Phase: N/A
• First received: September 13, 2012
• Last updated: June 2, 2016
• Start date: July 2012
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Roux-en-Y Gastric Bypass

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	Weight reduction	excess weight loss (%EWL)	2 years	No
Secondary	Decrease in comorbidities	diabetes mellitus, hypertension, hypercholesterolemia, arthrosis	2 years	No
Secondary	Quality of life	SF-36 and BAROS	2 years	No
Secondary	Complications and re-operations	bleeding, wound infections, intra-abdominal abcess, anastomosis leakage, vitamine deficiencies	2 years	Yes