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

Severe Obesity Clinical Trial

— BMI>50  

Official title:

Effects of Long Biliopancreatic Limb vs Long Alimentary Limb in Superobesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02033577
• Other study ID #: NCT01514799
• Status: Recruiting
• Phase: N/A
• First received: January 9, 2014
• Last updated: March 16, 2015
• Start date: August 2011
• Est. completion date: August 2016

Study information

• Verified date: March 2015
• Source: Aleris Obesity
• Contact: Jan Hedenbro, MD,PhD
• Phone: +46705132572
• Email: jan.hedenbro[@]aleris.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different.

Study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.

Description:

Randomisation in the OR between long biliopancreatic limb and long alimentary limb. GAstric component identical.

Perioperative biopsies to assess mucosal properties at the gastrojejunostomy and the enteroanastomosis. Repeat biopsies (gastroscopy) at one year to identify changes in the mucosa at the Gastroenteroanastomosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• BMI > 50

Exclusion Criteria:

• Psychiatric disease

• Inflammatory bowel disease

• inability to understand Swedish

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity, Morbid
• Severe Obesity

Intervention

Procedure:
• Distal gastrojejunal bypass
RYGB with 200 cm BP limb and 150 cm common limb, effect on EWL, QoL and complications
• RYGB
RYGB with 60 cm BP limb and 150 cm alimentary limb, effect on

Locations

Country	Name	City	State
Sweden	Aleris Obesity	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Aleris Obesity	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Short-term complications	Time to discharge, leaks, bleeding	0-30 days postoperatively	Yes
Primary	Body weight reduction	Body weight reduction is currently the best substitute endpoint to correlate with the hard endpopints such as death, comorbidities etc.	2 years from end of inclusion	No
Secondary	Patient assessed quality of life	We employ SF-36, Op-9, GSRS, TFEQ scales	2 years from end of inclusion	Yes