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

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ClinicalTrials.gov Identifier: NCT01686997
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Rijnstate Hospital

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 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.


Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Roux-en-Y Gastric Bypass Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: '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'
Study Start Date : July 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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


Secondary Outcome Measures :
  1. Decrease in comorbidities [ Time Frame: 2 years ]
    diabetes mellitus, hypertension, hypercholesterolemia, arthrosis

  2. Quality of life [ Time Frame: 2 years ]
    SF-36 and BAROS

  3. Complications and re-operations [ Time Frame: 2 years ]
    bleeding, wound infections, intra-abdominal abcess, anastomosis leakage, vitamine deficiencies



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Ages Eligible for Study:   18 Years to 65 Years   (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

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

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): NCT01686997


Locations
Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Principal Investigator: F.J. Berends, MD, PhD Rijnstate Hospital

Responsible Party: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT01686997     History of Changes
Other Study ID Numbers: Elegance01
First Posted: September 18, 2012    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:
Obesity
Weight Loss
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes