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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT05797220
Eligibility Criteria:
Inclusion Criteria:
* Patients with complaints longer than 8 weeks (chronic anal fissure)
* Patients who completed at least 24 months of follow-up (3rd day, 10th day, 1st-month, and 2nd-month face-to-face clinic visits and 6, 12, and 24 months phone calls)
* Patients who received conservative treatments including topical diltiazem and nitrites
Exclusion Criteria:
* Patients with previous anal surgery (lateral internal sphincterotomy, hemorrhoidectomy, anal fistula)
* Patients with inflammatory bowel diseases
* Patients with accompanying anorectal disease (hemorrhoids, anal fistula, abscess)
* Patients who underwent botulinum toxin injection within 1 year before recruitment
* Patients with anterior, lateral, or multiple fissures
* Comorbidities (AIDS, sexually transmitted disease, tuberculosis, leukemia)
* Pregnancy
* Prescription of calcium canal blockers or nitrites
* Hypersensitivity to diltiazem or botulinum toxin
* Patients without anal pain
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05797220
Study Brief:
Protocol Section:
NCT05797220