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

Takeda

Status: Completed

Conditions: Rectal Fistula; Crohn Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT04876690

IBD-5007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

15 participants in 1 patient group

CD Participants With CPF

Description:

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.