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Extended Pouch Roux-en-Y Gastric Bypass Study

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Extended Pouch RYGB
Standard RYGB
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Bariatric surgery, Roux-en-Y Gastric Bypass

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rijnstate Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard RYGB

Extended Pouch RYGB

Arm Description

Standard RYGB

Restrictive/extended pouch RYGB

Outcomes

Primary Outcome Measures

Weight reduction
Excess weight loss (%EWL)

Secondary Outcome Measures

Change in comorbidities
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: comorbidity resolved comorbidity improved comorbidity unchanged comorbidity worsened This will be done for diabetes mellitus, hypertension, dislipedimia and OSAS.
Change in comorbidities
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: comorbidity resolved comorbidity improved comorbidity unchanged comorbidity worsened This will be done for diabetes mellitus, hypertension, dislipidemia and OSAS.

Full Information

First Posted
August 13, 2014
Last Updated
June 2, 2016
Sponsor
Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02218957
Brief Title
Extended Pouch Roux-en-Y Gastric Bypass Study
Official Title
Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a Prospective Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Bariatric surgery, Roux-en-Y Gastric Bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard RYGB
Arm Type
Active Comparator
Arm Description
Standard RYGB
Arm Title
Extended Pouch RYGB
Arm Type
Experimental
Arm Description
Restrictive/extended pouch RYGB
Intervention Type
Procedure
Intervention Name(s)
Extended Pouch RYGB
Intervention Type
Procedure
Intervention Name(s)
Standard RYGB
Primary Outcome Measure Information:
Title
Weight reduction
Description
Excess weight loss (%EWL)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in comorbidities
Description
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: comorbidity resolved comorbidity improved comorbidity unchanged comorbidity worsened This will be done for diabetes mellitus, hypertension, dislipedimia and OSAS.
Time Frame
2 years
Title
Change in comorbidities
Description
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: comorbidity resolved comorbidity improved comorbidity unchanged comorbidity worsened This will be done for diabetes mellitus, hypertension, dislipidemia and OSAS.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Complications
Description
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.
Time Frame
2 years
Title
Quality of life
Description
The quality of life will be assessed by using the BAROS.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Homan, MD
Organizational Affiliation
Rijnstate Hospital Arnhem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6800WC
Country
Netherlands

12. IPD Sharing Statement

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Extended Pouch Roux-en-Y Gastric Bypass Study

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