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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
  Purpose

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 Intervention
Morbid Obesity
Procedure: Roux-en-Y Gastric Bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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'

Resource links provided by NLM:


Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • Weight reduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    excess weight loss (%EWL)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 280
Study Start Date: July 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686997

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

No publications provided

Responsible Party: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT01686997     History of Changes
Other Study ID Numbers: Elegance01
Study First Received: September 13, 2012
Last Updated: March 5, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:
Bariatric surgery
Roux-en-Y Gastric Bypass

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014