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

Weight Loss Clinical Trial

Official title:

Randomized Study Comparing the Effects of Gastric Bypass Using a Long BP-limb vs. a Long Alimentary Limb in Morbid Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514799
• Other study ID #: 2011_HG_Aleris_limb_length
• Status: Completed
• Phase: N/A
• Start date: August 29, 2011
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2020
• Source: Aleris Obesity
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 1, 2020
• Est. primary completion date: November 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid
• Weight Loss

Intervention

Procedure:
• gastric bypass
two techniques of gastric bypass for studying the effects of making a long BP-limb

Locations

Country	Name	City	State
Sweden	Aleris Obesity Skåne	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Aleris Obesity

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight reduction	absolute BW reduction, percentage of patients reaching BMI below 30,	5 years
Secondary	gastrointestinal function	SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables	5 years