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

June 2, 2016 updated by: Rijnstate Hospital

'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'

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Primairy long biliopancreatic limb RYGB
Roux limb 75 cm and Biliopancreatic Limb 150 cm
Procedure: Roux-en-Y Gastric Bypass
Active Comparator: Redo Long biliopancreatic limb RYGB
Roux limb 75 cm and Biliopancreatic limb 150 cm
Procedure: Roux-en-Y Gastric Bypass
Active Comparator: Primairy standard RYGB
Roux limb 150 cm and Biliopancreatic limb 75 cm
Procedure: Roux-en-Y Gastric Bypass
Active Comparator: Redo standard RYGB
Roux limb 150 cm and Biliopancreatic limb 75 cm
Procedure: Roux-en-Y Gastric Bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight reduction
Time Frame: 2 years
excess weight loss (%EWL)
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Investigators

  • Principal Investigator: F.J. Berends, MD, PhD, Rijnstate Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 13, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimate)

September 18, 2012

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Elegance01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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