Intraoperative Measuring of Small Bowel Length Compared to Measuring by Magnetic Resonance Imaging (MRI) in Morbid Obese Patients

Terminated

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

• Registration Number: NCT00740662
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

An important step during a gastric bypass operation for the treatment of morbid obesity is the measuring of the small bowel length. At several reoperations we found a length increase of the lowest part of the small intestine of up to 80% compared to the measured length at the initial operation. On the one hand, this reflects a normal technical error of small bowel measuring due to the variable state of contraction of the bowel, but on the other hand, it could also be due to a compensatory increase in intestinal length after the operation. New protocols allow measuring of the small bowel length by MRI. Comparing the preoperative and later on several postoperative measurements by MRI with the initial intraoperative length measuring should allow to validate the new MRI protocol and in the same time quantify the eventual small bowel length increase. We plan to include 20 patients in this study.

Detailed Description

Background:

An important step during a gastric bypass operation for the treatment of morbid obesity is the measuring of the small bowel length in order to define the lengths of the alimentary, biliopancreatic and common channel. The measuring itself is technically simple but has always an error due to the variable state of contraction of the small bowel. In distal gastric bypass a common channel length of 100 to 150 cm is chosen which induces an iatrogenic short bowel syndrome. At several reoperations we found a length increase of the common channel of up to 80% compared to the measured length at the initial operation. Former studies seem to indicate that an adaptation of small bowel length may occur in animals with short bowel syndrome or after intestinal bypass surgery. Longterm results of gastric bypass surgery often show weight regain after 3 to 5 years which could be due to the afore mentioned compensatory mechanism.

Newer MRI protocols allow for non-invasive measurement of the small bowel length. Comparing the preoperative and later on several postoperative measurements by MRI with the initial intraoperative length measuring should allow to validate the new MRI protocol and in the same time quantify the eventual small bowel length increase.

Objective:

In-vivo verification of small bowel length measurements made by MRI, quantification of a possible increase of the common channel length in the long run after distal gastric bypass.

Methods:

The preoperative small bowel length measurement by MRI is compared to the length measured intraoperatively. MRIs before discharge postoperatively as well as after 6 and 12 months are used to detect an eventual increase of the common channel length.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-22
• Study First Posted: 2008-08-25
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• morbid obese patient
• scheduled for distal gastric bypass
• informed consent for operation and study obtained

Exclusion Criteria

• history of former small bowel resection
• weight > 150 kg
• history of claustrophobia
• general contraindications for MRI (pacer, joint prosthesis, ear implant, etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Distal gastric bypass	Distal gastric bypass

Primary Outcome Measures

Name	Time	Method
Small bowel length in vivo compared to measurements by MRI	preoperative, previous to hospital discharge, 6 and 12 months postoperative

Secondary Outcome Measures

Name	Time	Method
Compensatory increase of the common channel (small bowel) after distal bypass	12 months postoperative
Correlation of longterm weight regain with increase of common channel length	12 months postoperative

Trial Locations

Locations (2)

Department of Visceral and Transplantsurgery, Bern University Hopsital; 🇨🇭 Bern, Switzerland

Institute of diagnostic, interventional and pediatric Radiology, Bern University Hospital; 🇨🇭 Bern, Switzerland