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

This study has been terminated.
(Recruiting problems)
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00740662
First received: August 22, 2008
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Morbid Obesity
Weight Loss
Procedure: Distal gastric bypass

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study for the Quantification of a Compensatory Increase in Small Bowel Length After Roux-en-Y Gastric Bypass in Morbid Obese Patients by Pre- and Postoperative Length-Measuring With MRI Compared to Intraoperative Length-Measuring

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Small bowel length in vivo compared to measurements by MRI [ Time Frame: preoperative, previous to hospital discharge, 6 and 12 months postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compensatory increase of the common channel (small bowel) after distal bypass [ Time Frame: 12 months postoperative ] [ Designated as safety issue: No ]
  • Correlation of longterm weight regain with increase of common channel length [ Time Frame: 12 months postoperative ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: January 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Distal gastric bypass
Procedure: Distal gastric bypass
Distal gastric bypass

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Morbid obese patients scheduled for distal gastric bypass

Criteria

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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740662

Locations
Switzerland
Department of Visceral and Transplantsurgery, Bern University Hopsital
Bern, Switzerland, 3010
Institute of diagnostic, interventional and pediatric Radiology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Director: Jean-Marc Heinicke, MD Department of Visceral and Transplant Surgery, Bern University Hospital
Principal Investigator: Philipp C Nett, Dr DRNN, Inselspital, Bern University Hospital, Switzerland
  More Information

Publications:
Responsible Party: Jean-Marc Heinicke, MD, Department of Visceral and Transplantsurgery, Bern University Hospital
ClinicalTrials.gov Identifier: NCT00740662     History of Changes
Other Study ID Numbers: KEK248_07
Study First Received: August 22, 2008
Last Updated: December 19, 2012
Health Authority: Switzerland: Independent Local Research Ethic Commission

Keywords provided by University Hospital Inselspital, Berne:
morbid obesity
small bowel
gastric bypass
weight loss

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 17, 2014