NCT04876690

A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas

Quality of Life of Crohn's Disease Patients With Complex Perianal Fistulas: an Observational, Cross-sectional Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of the study is to assess the quality of life of people with Crohn's disease after treatment for complex perianal fistulas (CPF) in a standard clinic setting. Study doctors will review the participants' medical records in the last 3 years. Participants will also be asked to visit the clinic once to complete 1 questionnaire on their quality of life.

Detailed description

This is a national, observational, cross-sectional study. The study will assess the general QoL among CD participants with CPFs in the Portuguese routine clinical practice. This study will enroll approximately 80 participants. All participants will be enrolled in one observational cohort. The data will be collected retrospectively, from the medical records, on healthcare resource utilization and on the pharmacological and surgical treatments used for the management of CPFs in the three years prior to the inclusion visit. This multi-center trial will be conducted in Portugal. The overall duration of this study is approximately 8 months.

Conditions

• Crohn Disease
• Rectal Fistula

Timeline

• Start date: 2021-07-09
• Primary completion: 2022-05-27
• Completion: 2022-05-27
• First posted: 2021-05-06
• Last updated: 2024-08-05
• Results posted: 2024-08-05

Locations

5 sites across 1 country: Portugal