Extended Pouch Roux-en-Y Gastric Bypass Study

June 2, 2016 updated by: Rijnstate Hospital

Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: 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 a restrictive/extended pouch on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the restrictive/extended pouch 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 (normal pouch) and restrictive/extended pouch RYGB.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

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

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6800WC
        • Rijnstate Hospital

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

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard RYGB
Procedure: Standard RYGB
Experimental: Extended Pouch RYGB
Restrictive/extended pouch RYGB
Procedure: Extended Pouch RYGB

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
Change in comorbidities
Time Frame: 2 years

Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups:

  1. comorbidity resolved
  2. comorbidity improved
  3. comorbidity unchanged
  4. comorbidity worsened

This will be done for diabetes mellitus, hypertension, dislipedimia and OSAS.
2 years
Change in comorbidities
Time Frame: 2 years

Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups:

  1. comorbidity resolved
  2. comorbidity improved
  3. comorbidity unchanged
  4. comorbidity worsened

This will be done for diabetes mellitus, hypertension, dislipidemia and OSAS.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 2 years
Complications will be divided in short-term complications (within 30 days after operation) and long-term complications (after 30 days). All adverse event will be registered.
2 years
Quality of life
Time Frame: 2 years
The quality of life will be assessed by using the BAROS.
2 years

Collaborators and Investigators

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

Sponsor

Rijnstate Hospital

Investigators

  • Principal Investigator: Jens Homan, MD, Rijnstate Hospital Arnhem

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

August 1, 2014

Primary Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

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

  • ExtPouch

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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