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

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Roux-en-Y Gastric Bypass
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Bariatric surgery, Roux-en-Y Gastric Bypass

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rijnstate Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Primairy long biliopancreatic limb RYGB

Redo Long biliopancreatic limb RYGB

Primairy standard RYGB

Redo standard RYGB

Arm Description

Roux limb 75 cm and Biliopancreatic Limb 150 cm

Roux limb 75 cm and Biliopancreatic limb 150 cm

Roux limb 150 cm and Biliopancreatic limb 75 cm

Roux limb 150 cm and Biliopancreatic limb 75 cm

Outcomes

Primary Outcome Measures

Weight reduction
excess weight loss (%EWL)

Secondary Outcome Measures

Decrease in comorbidities
diabetes mellitus, hypertension, hypercholesterolemia, arthrosis
Quality of life
SF-36 and BAROS
Complications and re-operations
bleeding, wound infections, intra-abdominal abcess, anastomosis leakage, vitamine deficiencies

Full Information

First Posted
September 13, 2012
Last Updated
June 2, 2016
Sponsor
Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01686997
Brief Title
Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities
Acronym
Elegance
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 Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Bariatric surgery, Roux-en-Y Gastric Bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primairy long biliopancreatic limb RYGB
Arm Type
Active Comparator
Arm Description
Roux limb 75 cm and Biliopancreatic Limb 150 cm
Arm Title
Redo Long biliopancreatic limb RYGB
Arm Type
Active Comparator
Arm Description
Roux limb 75 cm and Biliopancreatic limb 150 cm
Arm Title
Primairy standard RYGB
Arm Type
Active Comparator
Arm Description
Roux limb 150 cm and Biliopancreatic limb 75 cm
Arm Title
Redo standard RYGB
Arm Type
Active Comparator
Arm Description
Roux limb 150 cm and Biliopancreatic limb 75 cm
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y Gastric Bypass
Primary Outcome Measure Information:
Title
Weight reduction
Description
excess weight loss (%EWL)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Decrease in comorbidities
Description
diabetes mellitus, hypertension, hypercholesterolemia, arthrosis
Time Frame
2 years
Title
Quality of life
Description
SF-36 and BAROS
Time Frame
2 years
Title
Complications and re-operations
Description
bleeding, wound infections, intra-abdominal abcess, anastomosis leakage, vitamine deficiencies
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F.J. Berends, MD, PhD
Organizational Affiliation
Rijnstate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
30073496
Citation
Homan J, Boerboom A, Aarts E, Dogan K, van Laarhoven C, Janssen I, Berends F. A Longer Biliopancreatic Limb in Roux-en-Y Gastric Bypass Improves Weight Loss in the First Years After Surgery: Results of a Randomized Controlled Trial. Obes Surg. 2018 Dec;28(12):3744-3755. doi: 10.1007/s11695-018-3421-7.
Results Reference
derived

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Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities

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