Effects of Long Biliopancreatic Limb Versus Long Alimentary Limb in Superobesity, a Randomized Study (BMI>50)

Effects of Long Biliopancreatic Limb vs Long Alimentary Limb in Superobesity

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.

Study Overview

• Status: Unknown
• Conditions: Severe Obesity
• Intervention / Treatment: Procedure: Distal gastrojejunal bypass; Procedure: RYGB

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Hedenbro, MD,PhD; Phone Number: +46705132572; Email: jan.hedenbro@aleris.se
• Study Contact Backup: Name: Hjortur G Gislason, MD,PhD; Phone Number: +4748891375; Email: hjortur.gislason@aleris.no

Study Locations

• Sweden
  • Lund, Sweden
    • Recruiting
    • Aleris Obesity
    • Contact: Bent Johnny Nergaard, MD; Phone Number: +4792861730; Email: bjnergard@me.com
    • Contact: Jan Hedenbro
    • Sub-Investigator: Bent Johnny Nergaard, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI > 50

Exclusion Criteria:

• Psychiatric disease
• Inflammatory bowel disease
• inability to understand Swedish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distal gastrojejunal bypass; RYGB with 200 cm BP limb and 150 cm common limb	Procedure: Distal gastrojejunal bypass; RYGB with 200 cm BP limb and 150 cm common limb, effect on EWL, QoL and complications
Active Comparator: RYGB; RYGB with 60 cm BP limb and 150 cm alimentary limb	Procedure: RYGB; RYGB with 60 cm BP limb and 150 cm alimentary limb, effect on

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient assessed quality of life	We employ SF-36, Op-9, GSRS, TFEQ scales	2 years from end of inclusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term complications	Time to discharge, leaks, bleeding	0-30 days postoperatively

Collaborators and Investigators

• Sponsor: Aleris Obesity
• Collaborators: Lund University

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: January 9, 2014
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 13, 2014

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 16, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: NCT01514799