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NCT Number: NCT02218957

Extended Pouch Roux-en-Y Gastric Bypass Study

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.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate Hospital

Arnhem, Gelderland, 6800WC, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended Pouch RYGB

Procedure

Standard RYGB

Procedure

Primary outcomes

  1. Weight reduction

    Time frame: 2 years

    Excess weight loss (%EWL)

Secondary outcomes

  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:

    • comorbidity resolved
    • comorbidity improved
    • comorbidity unchanged
    • comorbidity worsened

    This will be done for diabetes mellitus, hypertension, dyslipidemia 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:

    • comorbidity resolved
    • comorbidity improved
    • comorbidity unchanged
    • comorbidity worsened

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

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a Prospective Randomized Control Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2018
First posted
Aug 18, 2014
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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