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

Sponsor

Aleris Obesity (Industry)

Overall Status

Completed

CT.gov ID

NCT01514799

Collaborator

(none)

140

Enrollment

Location

Arms

101.1

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity Weight Loss	Procedure: gastric bypass	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised study between long and standard biliopancreatic limb in gstric bypass surgeryRandomised study between long and standard biliopancreatic limb in gstric bypass surgery

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Randomisation in the OR, (closed envelopes, blocks of six) no further info to ward or follow-up unit. No specific info as to randomisation outcome given to patients, all patients follow same protocol. Code number in operative charts.

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

Actual Study Start Date :

Aug 29, 2011

Actual Primary Completion Date :

Nov 20, 2015

Actual Study Completion Date :

Feb 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

body weight reduction [5 years]
absolute BW reduction, percentage of patients reaching BMI below 30,

Secondary Outcome Measures

gastrointestinal function [5 years]
SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Aleris Obesity Skåne	Lund		Sweden	SE 222 70

Sponsors and Collaborators

Aleris Obesity

Investigators

Principal Investigator: Jan L Hedenbro, Lunds Universitets Diabetescentrum

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aleris Obesity

ClinicalTrials.gov Identifier:

NCT01514799

Other Study ID Numbers:

2011_HG_Aleris_limb_length

First Posted:

Jan 23, 2012

Last Update Posted:

Feb 25, 2020

Last Verified:

Feb 1, 2020

Keywords provided by Aleris Obesity

Additional relevant MeSH terms:

Obesity

Obesity, Morbid

Weight Loss

Study Results

No Results Posted as of Feb 25, 2020