NCT03981939

Perianal Fistula (PAF) Validation and Burden of Illness Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,032 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 105 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to gain a better understanding of the disease burden and unmet need of perianal fistulas within Crohn's disease (CD) in Ontario.

Detailed description

This is a retrospective follow-up observational study of participants with CD with and without complex perianal fistula (CPAF) from January 2002 to March 2017. The study will verify the potential of using procedure codes to reliably identify participants with CPAF in Validation Study (Objective 1), compare Crohn's participants with CPAF (cases) to matched participants without CPAF (controls) to determine the disease burden and healthcare resource utilization of Crohn's related CPAF in Ontario, and will describe the participant's journey among Crohn's participants following the first diagnosis of CPAF (Objective 3). The study will enroll approximately 600 participants (300 participants with CPAF and 300 participants without CPAF). All participants will be enrolled in 2 observation groups: * CD Participants with/without CPAF (ICES data) * CD Participants with CPAF - The Ottawa Hospital (TOH) 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 index period: April 2002 and July 2013. Participants will be followed up retrospectively from the index period (that is onset of CPAF) to the end of study (Objective 2), and for 5 years following the (Objective 3) index date defined as onset of CPAF will be selected based on the first time they meet the first code in the case definition identified in Objective 1 between April 1, 2005 to March 31, 2012. The overall time for data collection in this study will be approximately 7 months.

Conditions

• Inflammatory Bowel Disease
• Perianal Fistula
• Crohns Disease

Interventions

Type	Name	Description
OTHER	No intervention	This is an observational study, participants did not receive any intervention in this study and were only observed retrospectively.

Timeline

• Start date: 2019-07-02
• Primary completion: 2019-12-17
• Completion: 2019-12-31
• First posted: 2019-06-11
• Last updated: 2021-04-21
• Results posted: 2021-04-21

Locations

1 site across 1 country: Canada