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Extended Pouch Roux-en-Y Gastric Bypass Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02218957
Recruitment Status : Unknown
Verified June 2016 by Rijnstate Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 18, 2014
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Rijnstate Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Extended Pouch RYGB Procedure: Standard RYGB Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a Prospective Randomized Control Trial
Study Start Date : August 2014
Estimated Primary Completion Date : October 2017
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard RYGB
Standard RYGB
 Procedure: Standard RYGB
Experimental: Extended Pouch RYGB
Restrictive/extended pouch RYGB
 Procedure: Extended Pouch RYGB


Outcome Measures
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Primary Outcome Measures :
  1. Weight reduction [ Time Frame: 2 years ]
    Excess weight loss (%EWL)


Secondary Outcome Measures :
  1. 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. 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.



Other Outcome Measures:
  1. 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. Quality of life [ Time Frame: 2 years ]
    The quality of life will be assessed by using the BAROS.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218957


Locations
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Netherlands
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800WC
Sponsors and Collaborators
Rijnstate Hospital
Investigators
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Principal Investigator: Jens Homan, MD Rijnstate Hospital Arnhem
More Information
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Responsible Party: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT02218957    
Other Study ID Numbers: ExtPouch
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016
Keywords provided by Rijnstate Hospital:
Bariatric surgery
Roux-en-Y Gastric Bypass
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight