Real life management Crohn's perianal fistula (ALERT-CD)(‘a snapshot study’)

Conditions: Crohn's disease
Perianal fistula

Registration Number: NL-OMON24601

Lead Sponsor: Erasmus Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

diagnosed Crohn’s perianal fistula (regardless of the extent of fistulizing disease)
- age =18 yrs
- speak / master the Dutch language in order to comprehend study content and informed consent
- written informed consent

Exclusion Criteria

- Age < 18 years
- Cryptoglandular fistula (non-CD)
- Rectovaginal fistula
- Entero-enteral fistula
- Entero-vesical fistula

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the current management, effects on quality of life and medical costs of perianal fistula in Crohn’s disease in (routine) clinical practice in The Netherlands

Secondary Outcome Measures

Name	Time	Method
- To identify treatment variation of perianal fistula between inflammatory bowel disease (IBD) centers in the Netherlands;<br>- To assess the variation in definition of type of fistula (simple or complex) as judged by the treating physician; including definition used for this distinction; and modality used (clinical assessment, EUS, MRI). <br>- To assess quality of life of CD patients with perianal fistula, during longitudinal follow-up; <br>- To assess direct and indirect costs of current management of CD patients with perianal fistula, including costs related to work productivity;<br>- To assess the patient journey of perianal fistula in CD: patient-reported delay in diagnosis; is the treatment of patients discussed in a multidisciplinary team and if so, when; distribution of patient information; the use of e-health tools (eg. IBD monitoring apps); time to start of medication / surgery; what type of surgery performed.