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

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.
 
ClinicalTrials.gov Identifier: NCT02033577
Recruitment Status : Unknown
Verified March 2015 by Jan Hedenbro, Aleris Obesity.
Recruitment status was:  Recruiting
First Posted : January 13, 2014
Last Update Posted : March 17, 2015
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Jan Hedenbro, Aleris Obesity

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.


Condition or disease Intervention/treatment Phase
Severe Obesity Procedure: Distal gastrojejunal bypass Procedure: RYGB Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Long Biliopancreatic Limb vs Long Alimentary Limb in Superobesity
Study Start Date : August 2011
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patient assessed quality of life [ Time Frame: 2 years from end of inclusion ]
    We employ SF-36, Op-9, GSRS, TFEQ scales


Other Outcome Measures:
  1. Short-term complications [ Time Frame: 0-30 days postoperatively ]
    Time to discharge, leaks, bleeding



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 50

Exclusion Criteria:

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

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 ClinicalTrials.gov identifier (NCT number): NCT02033577


Contacts
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Contact: Jan Hedenbro, MD,PhD +46705132572 jan.hedenbro@aleris.se
Contact: Hjortur G Gislason, MD,PhD +4748891375 hjortur.gislason@aleris.no

Locations
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Sweden
Aleris Obesity Recruiting
Lund, Sweden
Contact: Bent Johnny Nergaard, MD    +4792861730    bjnergard@me.com   
Contact: Jan Hedenbro         
Sub-Investigator: Bent Johnny Nergaard, MD         
Sponsors and Collaborators
Aleris Obesity
Lund University

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Responsible Party: Jan Hedenbro, Senior scientist, Aleris Obesity
ClinicalTrials.gov Identifier: NCT02033577    
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms