Status:
COMPLETED
A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas
Lead Sponsor:
Takeda
Conditions:
Crohn Disease
Rectal Fistula
Eligibility:
All Genders
18+ years
Brief 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 t...
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 app...
Eligibility Criteria
Inclusion
- Diagnosed with CD.
- Presence of CPF(s), defined as \>=1 of the following criteria:
- High intersphincteric, high transsphincteric, extrasphincteric, or suprasphincteric location;
- \>=2 external openings;
- Associated collections.
- Attending routine gastroenterology appointments at the participating hospitals.
Exclusion
- Diagnosed with ulcerative colitis or indeterminate inflammatory bowel disease (IBD).
- With non-complex fistulas or with fistulas types other than perianal (example, rectovaginal).
Key Trial Info
Start Date :
July 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 27 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04876690
Start Date
July 9 2021
End Date
May 27 2022
Last Update
August 5 2024
Active Locations (5)
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1
Centro Hospitalar e Universitario de Coimbra (CHUC)
Coimbra, Portugal, 3000-075
2
Centro Hospitalar Universitario de Lisboa Central (CHULC)
Lisbon, Portugal, 1169-050
3
Centro Hospitalar Universitario Lisboa Norte - Hospital de Santa Maria (CHULN-HSM)
Lisbon, Portugal, 1649-028
4
Centro Hospitalar Universitario de Sao Joao (CHUSJ)
Porto, Portugal, 4200-319