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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01514799
Recruitment Status : Unknown
Verified March 2015 by Aleris Obesity.
Recruitment status was:  Recruiting
First Posted : January 23, 2012
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
Aleris Obesity

Brief Summary:

Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough. 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 proximal (oral) portion of the jejunum from food contact with the effects when preventing the jejunum from contact with bile and pancreatic juice.

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

Condition or disease Intervention/treatment
Morbid Obesity Weight Loss Procedure: gastric bypass

Detailed Description:

Two variations of gastric bypass are compared:

Method 1:A 200 cm BP-limb (distance Treitz to EA)+ 150 cm common channel (EA to ileocecal valve) + Roux-Y-limb variable Method 2: 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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Study Comparing the Effects of Gastric Bypass Using a Long BP-limb vs. a Long Alimentary Limb in Morbid Obesity
Study Start Date : June 2011
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. body weight reduction [ Time Frame: 2 years ]
    absolute BW reduction, percentage of patients reaching BMI below 30,

Secondary Outcome Measures :
  1. gastrointestinal function [ Time Frame: 2 years ]
    SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01514799

Contact: Hjortur Gislason, MD, PhD +4748891375
Contact: Jan L Hedenbro, MD, PhD +46705132572

Aleris Obesity Skåne Recruiting
Lund, Sweden, SE 222 70
Contact: Jan L Hedenbro, MD PhD    +46705132572   
Principal Investigator: Hjortur Gislason, MD PhD         
Sponsors and Collaborators
Aleris Obesity

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Aleris Obesity Identifier: NCT01514799     History of Changes
Other Study ID Numbers: 2011_HG_Aleris_limb_length
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Aleris Obesity:
gastric bypass
morbid obesity
gut function
weight loss

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