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

Not Applicable

Completed

• Conditions: Morbid Obesity; Weight Loss
• Interventions: Procedure: gastric bypass

• Registration Number: NCT01514799
• Lead Sponsor: Aleris Obesity

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.

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 Timeline

• Study Start: 2011-08-29
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Primary Completion: 2015-11-20
• Status Verified: 2020-02
• Study Completion: 2020-02-01
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long BP limb	gastric bypass	200 cm BP limb
standard length bp limb, long alimentary limb	gastric bypass	our normal way of doing a gastric bypass 60 cm BP limb

Primary Outcome Measures

Name	Time	Method
body weight reduction	5 years	absolute BW reduction, percentage of patients reaching BMI below 30,

Secondary Outcome Measures

Name	Time	Method
gastrointestinal function	5 years	SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables

Trial Locations

Locations (1)

Aleris Obesity Skåne; 🇸🇪 Lund, Sweden