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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01686997
First Posted: September 18, 2012
Last Update Posted: June 3, 2016
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.
Information provided by (Responsible Party):
Rijnstate Hospital
September 13, 2012
September 18, 2012
June 3, 2016
July 2012
January 2016   (Final data collection date for primary outcome measure)
Weight reduction [ Time Frame: 2 years ]
excess weight loss (%EWL)
Same as current
Complete list of historical versions of study NCT01686997 on ClinicalTrials.gov Archive Site
  • Decrease in comorbidities [ Time Frame: 2 years ]
    diabetes mellitus, hypertension, hypercholesterolemia, arthrosis
  • Quality of life [ Time Frame: 2 years ]
    SF-36 and BAROS
  • Complications and re-operations [ Time Frame: 2 years ]
    bleeding, wound infections, intra-abdominal abcess, anastomosis leakage, vitamine deficiencies
Same as current
Not Provided
Not Provided
 
Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities
'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'

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Morbid Obesity
Procedure: Roux-en-Y Gastric Bypass
  • Active Comparator: Primairy long biliopancreatic limb RYGB
    Roux limb 75 cm and Biliopancreatic Limb 150 cm
    Intervention: Procedure: Roux-en-Y Gastric Bypass
  • Active Comparator: Redo Long biliopancreatic limb RYGB
    Roux limb 75 cm and Biliopancreatic limb 150 cm
    Intervention: Procedure: Roux-en-Y Gastric Bypass
  • Active Comparator: Primairy standard RYGB
    Roux limb 150 cm and Biliopancreatic limb 75 cm
    Intervention: Procedure: Roux-en-Y Gastric Bypass
  • Active Comparator: Redo standard RYGB
    Roux limb 150 cm and Biliopancreatic limb 75 cm
    Intervention: Procedure: Roux-en-Y Gastric Bypass
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
April 2016
January 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01686997
Elegance01
No
Not Provided
Not Provided
Rijnstate Hospital
Rijnstate Hospital
Not Provided
Principal Investigator: F.J. Berends, MD, PhD Rijnstate Hospital
Rijnstate Hospital
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP