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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24601

Enrollment

150

Registered

2021-09-21

Start date

2022-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- To identify treatment variation of perianal fistula between inflammatory bowel disease (IBD) centers in the Netherlands; - 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). - To assess quality of life of CD patients with perianal fistula, during longitudinal follow-up; - To assess direct and indirect costs of current management of CD patients with perianal fistula, including costs related to work productivity; - 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.	—

Measure

Time frame

- To identify treatment variation of perianal fistula between inflammatory bowel disease (IBD) centers in the Netherlands; - 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). - To assess quality of life of CD patients with perianal fistula, during longitudinal follow-up; - To assess direct and indirect costs of current management of CD patients with perianal fistula, including costs related to work productivity; - 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.

—

Contacts

Public ContactMichiel Bak

Erasmus Medical Center

m.bak@erasmusmc.nl06 500 339 76

Outcome results