Clinical Trial: Magnetic Resonance (MR) Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: MR Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients

Brief Summary:

It is essential to know intestinal length and anastomotic type in post-operative short bowel syndrome patients. These parameters can help predict long-term intestinal failure with long-term parenteral nutrition usually needed for smallest lengths. Sometimes these parameters are unfortunately missing for lack of intraoperative measurement. Thus, it is necessary to develop non-invasive and reproducible techniques to assess small bowel length. This is the reason why the investigators will evaluate magnetic resonance (MR)-enterography and barium follow-through in this indication. There are at this time only two small studies evaluating barium follow-through for intestinal length measurement, and none evaluating MR-enterography. However, a major advantage of the latter is the lack of radiation exposure and possibility to perform 3D.

This will be an open labelled single center crossover study. Short bowel syndrome patients of the investigators center will be included after consent. The sequence of exams (MR enterography followed by barium follow-through or vice-versa) will be randomly assigned. Peroperative short bowel length measurement will be available for all patients. There will be one month between the two exams.

The main objective of this study is to assess the performance of MR-enterography in short bowel measurement in short bowel syndrome patients, the gold standard being peroperative length. Secondary objectives are to assess the performance of barium follow-through in short bowel measurement in these patients, and to show that barium follow-through does not perform better than MR-enterography. For that purpose the investigators will include 50 patients over 2 years.

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Nice

Current Primary Outcome: Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test [ Time Frame: at 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Assessment of the lack of difference between surgical and barium follow through small bowel length measurement with a comparison sample test [ Time Frame: at 3 months ]

Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nice

Dates:
Date Received: August 2, 2010
Date Started: July 2010
Date Completion: July 2012
Last Updated: August 17, 2010
Last Verified: June 2010