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

NCT01183793 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-08-18

No results posted yet for this study

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.

Conditions

  • Short Bowel Syndrome

Interventions

RADIATION

Barium follow-through and MR-enterography

Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • SCHNEIDER Stephane, PU-PH · Services d'Hépato-Gastroentérologie et Nutrition Clinique

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-10-31
Completion
2012-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01183793 on ClinicalTrials.gov