US Clinical Trial NCT03981939

Perianal Fistula Procedure Validation, Matched Case Control, and Patient Journey Study  Jun 7, 2019

This is a retrospective follow-up observational study of participants with CD with and without PAF from January 2002 to March 2017. The study will verify the potential of using procedure codes to reliably identify participants with PAF in Validation Study (Objective 1), compare Crohn's participants with PAF (cases) to matched participants without PAF (controls) to determine the disease burden and healthcare resource utilization of Crohn's related PAF in Ontario, and will describe the participant's journey among Crohn's participants following the first diagnosis of PAF (Objective 3).

The study will enroll approximately 600 participants (300 participants with PAF and 300 participants without PAF). All participants will be enrolled in 2 observation groups:

- CD Participants with PAF

- CD Participants without PAF

The data will be collected through Ontario health administrative data. Participants will be observed retrospectively who were diagnosed with CD with and without fistula between April 2002 and July 2013. Participants will be followed up retrospectively from the index period (that is onset of PAF) to the end of study (Objective 2), and for 5 years following the index date (Objective 3). The overall time for data collection in this study will be approximately 7 months.

Parties

Contacts
Investigators
Sponsors
Keywords
Crohn Disease Drug therapy Inflammatory Bowel Disease Perianal Fistula

JSON preview

Similar records

Title

Source:  NIH Last updated:  Jun 12, 2019

From ClinicalTrials.gov, a database of the U.S. National Institutes of Health, through its National Library of Medicine. This record may not reflect the most current and accurate biomedical/scientific data available from the NLM/NIH.