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Effects of Long Biliopancreatic Limb Versus Long Alimentary Limb in Superobesity, a Randomized Study (BMI>50)

Primary Purpose

Severe Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Distal gastrojejunal bypass
RYGB
Sponsored by
Aleris Obesity
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI > 50

Exclusion Criteria:

  • Psychiatric disease
  • Inflammatory bowel disease
  • inability to understand Swedish

Sites / Locations

  • Aleris ObesityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Distal gastrojejunal bypass

RYGB

Arm Description

RYGB with 200 cm BP limb and 150 cm common limb

RYGB with 60 cm BP limb and 150 cm alimentary limb

Outcomes

Primary Outcome Measures

Body weight reduction
Body weight reduction is currently the best substitute endpoint to correlate with the hard endpopints such as death, comorbidities etc.

Secondary Outcome Measures

Patient assessed quality of life
We employ SF-36, Op-9, GSRS, TFEQ scales

Full Information

First Posted
January 9, 2014
Last Updated
March 16, 2015
Sponsor
Aleris Obesity
Collaborators
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT02033577
Brief Title
Effects of Long Biliopancreatic Limb Versus Long Alimentary Limb in Superobesity, a Randomized Study
Acronym
BMI>50
Official Title
Effects of Long Biliopancreatic Limb vs Long Alimentary Limb in Superobesity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aleris Obesity
Collaborators
Lund University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different. Study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.
Detailed Description
Randomisation in the OR between long biliopancreatic limb and long alimentary limb. GAstric component identical. Perioperative biopsies to assess mucosal properties at the gastrojejunostomy and the enteroanastomosis. Repeat biopsies (gastroscopy) at one year to identify changes in the mucosa at the Gastroenteroanastomosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Distal gastrojejunal bypass
Arm Type
Experimental
Arm Description
RYGB with 200 cm BP limb and 150 cm common limb
Arm Title
RYGB
Arm Type
Active Comparator
Arm Description
RYGB with 60 cm BP limb and 150 cm alimentary limb
Intervention Type
Procedure
Intervention Name(s)
Distal gastrojejunal bypass
Intervention Description
RYGB with 200 cm BP limb and 150 cm common limb, effect on EWL, QoL and complications
Intervention Type
Procedure
Intervention Name(s)
RYGB
Intervention Description
RYGB with 60 cm BP limb and 150 cm alimentary limb, effect on
Primary Outcome Measure Information:
Title
Body weight reduction
Description
Body weight reduction is currently the best substitute endpoint to correlate with the hard endpopints such as death, comorbidities etc.
Time Frame
2 years from end of inclusion
Secondary Outcome Measure Information:
Title
Patient assessed quality of life
Description
We employ SF-36, Op-9, GSRS, TFEQ scales
Time Frame
2 years from end of inclusion
Other Pre-specified Outcome Measures:
Title
Short-term complications
Description
Time to discharge, leaks, bleeding
Time Frame
0-30 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI > 50 Exclusion Criteria: Psychiatric disease Inflammatory bowel disease inability to understand Swedish
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Hedenbro, MD,PhD
Phone
+46705132572
Email
jan.hedenbro@aleris.se
First Name & Middle Initial & Last Name or Official Title & Degree
Hjortur G Gislason, MD,PhD
Phone
+4748891375
Email
hjortur.gislason@aleris.no
Facility Information:
Facility Name
Aleris Obesity
City
Lund
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bent Johnny Nergaard, MD
Phone
+4792861730
Email
bjnergard@me.com
First Name & Middle Initial & Last Name & Degree
Jan Hedenbro
First Name & Middle Initial & Last Name & Degree
Bent Johnny Nergaard, MD

12. IPD Sharing Statement

Learn more about this trial

Effects of Long Biliopancreatic Limb Versus Long Alimentary Limb in Superobesity, a Randomized Study

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