Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT05405634
Eligibility Criteria:
Inclusion criteria
Three samples will be included:
1. Consecutive patients referred to the outpatient clinic at the Digestive Disease Centre, Bispebjerg Hospital in Denmark for botox injection for chronic anal fissure. Thus, the included patients will likely all have tried conservative treatment before referral, and are expected to represent a more homogeneous subset with longer standing disease, less spontaneous improvement, and a higher likelihood of being compliant with suggested therapy
2. Consecutive patients with an indication for revision of the fissure and anal injection of botulinum toxin in general anaesthesia
3. Healthy volunteers. These will be recruited among staff at the Digestive Disease Centre, Bispebjerg Hospital, Denmark.
Samples 1 and 2 will not be independent, as patients from group 1 may be included in group 2 depending on the clinical course. No direct comparisons between these two groups are planned (see analysis section).
Exclusion criteria
* Symptom duration of less than 8 weeks (groups 1 and 2)
* Known or suspected Crohn's disease
* Known or suspected active venereal disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT05405634
Study Brief:
Protocol Section:
NCT05405634