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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01686997
First received: September 13, 2012
Last updated: March 5, 2014
Last verified: March 2014

September 13, 2012
March 5, 2014
July 2012
December 2015   (final data collection date for primary outcome measure)
Weight reduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    diabetes mellitus, hypertension, hypercholesterolemia, arthrosis
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    SF-36 and BAROS
  • Complications and re-operations [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.
 
Active, not recruiting
280
December 2018
December 2015   (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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01686997
Elegance01
No
Rijnstate Hospital
Rijnstate Hospital
Not Provided
Principal Investigator: F.J. Berends, MD, PhD Rijnstate Hospital
Rijnstate Hospital
March 2014

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