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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Aleris Obesity
Sponsor:
Information provided by (Responsible Party):
Aleris Obesity
ClinicalTrials.gov Identifier:
NCT01514799
First received: January 18, 2012
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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 Intervention
Morbid Obesity
Weight Loss
Procedure: gastric bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Aleris Obesity:

Primary Outcome Measures:
  • body weight reduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    absolute BW reduction, percentage of patients reaching BMI below 30,


Secondary Outcome Measures:
  • gastrointestinal function [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables


Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514799

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

Locations
Sweden
Aleris Obesity Skåne Recruiting
Lund, Sweden, SE 222 70
Contact: Jan L Hedenbro, MD PhD    +46705132572    jan.hedenbro@aleris.se   
Principal Investigator: Hjortur Gislason, MD PhD         
Sponsors and Collaborators
Aleris Obesity
  More Information

No publications provided

Responsible Party: Aleris Obesity
ClinicalTrials.gov Identifier: NCT01514799     History of Changes
Other Study ID Numbers: 2011_HG_Aleris_limb_length
Study First Received: January 18, 2012
Last Updated: September 19, 2013
Health Authority: Sweden: Etikprövningsnämnden i Lund

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

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

ClinicalTrials.gov processed this record on September 11, 2014