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

March 16, 2015 updated by: Jan Hedenbro, Aleris Obesity

Effects of Long Biliopancreatic Limb vs Long Alimentary Limb in Superobesity

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden
        • Recruiting
        • Aleris Obesity
        • Contact:
        • Contact:
          • Jan Hedenbro
        • Sub-Investigator:
          • Bent Johnny Nergaard, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI > 50

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Distal gastrojejunal bypass
RYGB with 200 cm BP limb and 150 cm common limb
Procedure: Distal gastrojejunal bypass
RYGB with 200 cm BP limb and 150 cm common limb, effect on EWL, QoL and complications
Active Comparator: RYGB
RYGB with 60 cm BP limb and 150 cm alimentary limb
Procedure: RYGB
RYGB with 60 cm BP limb and 150 cm alimentary limb, effect on

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight reduction
Time Frame: 2 years from end of inclusion
Body weight reduction is currently the best substitute endpoint to correlate with the hard endpopints such as death, comorbidities etc.
2 years from end of inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient assessed quality of life
Time Frame: 2 years from end of inclusion
We employ SF-36, Op-9, GSRS, TFEQ scales
2 years from end of inclusion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term complications
Time Frame: 0-30 days postoperatively
Time to discharge, leaks, bleeding
0-30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aleris Obesity

Collaborators

Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT01514799

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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