CompletedNot Applicable

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

Portugal15 participantsStarted 2021-07-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Diagnosed with CD.
✓. Presence of CPF(s), defined as \>=1 of the following criteria:
✓. Attending routine gastroenterology appointments at the participating hospitals.

Exclusion criteria

✕. Diagnosed with ulcerative colitis or indeterminate inflammatory bowel disease (IBD).
✕. With non-complex fistulas or with fistulas types other than perianal (example, rectovaginal).

What they're measuring

Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12]

Timeframe: At inclusion visit (Day 1)

Meta-Scores of the SF-12 Questionnaire's Mental Component Score [MCS-12])

Timeframe: At inclusion visit (Day 1)

Trial details

NCT IDNCT04876690

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-05-27

Results submitted2023-05-18

View on ClinicalTrials.gov More Crohn Disease trials