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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-09

Study Completion Date

2022-05-27

Brief Summary

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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.

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Detailed Description

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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

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Crohn Disease Rectal Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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CD Participants With CPF

Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed with CD.
2. Presence of CPF(s), defined as \>=1 of the following criteria:

* High intersphincteric, high transsphincteric, extrasphincteric, or suprasphincteric location;
* \>=2 external openings;
* Associated collections.
3. Attending routine gastroenterology appointments at the participating hospitals.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No