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

February 24, 2020 updated by: Aleris Obesity

Randomized Study Comparing the Effects of Gastric Bypass Using a Long BP-limb vs. a Long Alimentary Limb in Morbid Obesity

Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough for proper weight control. Bypassing a longer segment of the gut may be more beneficial. Which part to bypass is not clear.

The investigators want to compare the effects between preventing a 60 cm proximal (oral) portion of the jejunum from food contact with the effects when preventing a 200 cm part of the jejunum from contact with bile and pancreatic juice.

Endpoints are quality of life, gastrointestinal function, and weight development.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two variations of gastric bypass are compared:

Method 1 (test method):A 200 cm BP-limb (distance Treitz to EA) + 150 cm common channel (EA to ileocecal valve) + Roux-Y-limb variable Method 2 (standard method): A 60 cm BP limb + 150 cm Roux-Y-limb + common channel variable.

Patients are evaluated according to the principles of the Scandinavian Obesity surgery registry (SOReg) with the addition of two additional questionnaires.

FU time is set at 5 years.

Study Type

Interventional

Enrollment (Actual)

140

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, SE 222 70
        • Aleris Obesity Skåne

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 50-65
  • Age 18-55
  • Conservative attempts at weight reduction failed

Exclusion Criteria:

  • Inability to speak and understand the Swedish language
  • Residence outside the county of Skåne
  • Psychotic disease
  • Inflammatory bowel disease

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
Active Comparator: standard length bp limb, long alimentary limb
our normal way of doing a gastric bypass 60 cm BP limb
Procedure: gastric bypass
two techniques of gastric bypass for studying the effects of making a long BP-limb
Experimental: Long BP limb
200 cm BP limb
Procedure: gastric bypass
two techniques of gastric bypass for studying the effects of making a long BP-limb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body weight reduction
Time Frame: 5 years
absolute BW reduction, percentage of patients reaching BMI below 30,
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastrointestinal function
Time Frame: 5 years
SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables
5 years

Collaborators and Investigators

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

Sponsor

Aleris Obesity

Investigators

  • Principal Investigator: Jan L Hedenbro, Lunds Universitets Diabetescentrum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 29, 2011

Primary Completion (Actual)

November 20, 2015

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 20, 2012

First Posted (Estimate)

January 23, 2012

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011_HG_Aleris_limb_length

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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