No registrations found.
ID
Source
Brief title
Health condition
Crohn's disease; Perianal fistula
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
- 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.
Background summary
This study aims to assess the current management, effects on quality of life and health care costs of perianal fistula in Crohn's disease (CD) patients in (routine) clinical practice in the Netherlands. A multinational observational cohort study (' a snapshot study') will be set up that will include patients with CD and a (persistent) perianal fistula in a participating hospital, already receiving medical and/or surgical treatment, or new onset of perianal fistula requiring treatment and/or follow-up will be assessed for eligibility.
Study objective
NA
Study design
Baseline - 3 months - 6 months - 12 months
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9739 |
| Other | METC of the Erasmus Medical Center : MEC-2021-0631 |