Can CT Enteroclysis Predict the Outcome of Crohn's Disease

August 7, 2015 updated by: Indiana University

Can CT Enteroclysis Predict the Response to Therapy and Outcome in Patient With Crohn's Disease

Specific CT Enteroclysis findings with or without other clinical and laboratory variables, can identify Crohn's disease patients who will response to medical therapy versus those who will either fail and require surgery or have uncontrolled disease.

Study Overview

Status

Completed

Conditions

Crohn's Disease

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Crohn's disease patients that have had a CT Enteroclysis as part of their clinical evaluation for symptomatic Crohn's disease will be eligible. Subjects who were later diagnosied with bowel malignancy and subjects with a period of follow-up of less than 1 year(without surgery) will be excluded.

Description

Inclusion Criteria:

Crohn's disease with CT Enteroclysis during symptomatic treatment

Exclusion Criteria:

Crohn's disease subjects who have had a follow-up less than 1 year, without surgery
Crohn's disease subjects that were later diagnosed with a bowel malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Retrospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
CTE with CD Crohn's disease patients who underwent a CT enteroclysis as part of their clinical evaluation for symptomatic Crohn's disease.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

Principal Investigator: Michael V. Chiorean, M.D., Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria