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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Aleris Obesity.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514799
First Posted: January 23, 2012
Last Update Posted: March 17, 2015
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.
Information provided by (Responsible Party):
Aleris Obesity
January 18, 2012
January 23, 2012
March 17, 2015
June 2011
June 2016   (Final data collection date for primary outcome measure)
body weight reduction [ Time Frame: 2 years ]
absolute BW reduction, percentage of patients reaching BMI below 30,
Same as current
Complete list of historical versions of study NCT01514799 on ClinicalTrials.gov Archive Site
gastrointestinal function [ Time Frame: 2 years ]
SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables
Same as current
Not Provided
Not Provided
 
Effects of Long Biliopancreatic Limb vs. Long Alimentary Limb in Superobesity, a Randomized Study
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. 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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Morbid Obesity
  • Weight Loss
Procedure: gastric bypass
two techniques of gastric bypass for studying the effects of making a long BP-limb
  • Active Comparator: standard length bp limb, long alimentary limb
    our normal way of doing a gastric bypass
    Intervention: Procedure: gastric bypass
  • Experimental: Long BP limb
    Intervention: Procedure: gastric bypass
Nergård BJ, Lindqvist A, Gislason HG, Groop L, Ekelund M, Wierup N, Hedenbro JL. Mucosal glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide cell numbers in the super-obese human foregut after gastric bypass. Surg Obes Relat Dis. 2015 Nov-Dec;11(6):1237-46. doi: 10.1016/j.soard.2015.03.021. Epub 2015 Apr 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
June 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01514799
2011_HG_Aleris_limb_length
No
Not Provided
Not Provided
Aleris Obesity
Aleris Obesity
Not Provided
Not Provided
Aleris Obesity
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP