EUCTR2017-001216-11-ES
Active, not recruiting
Phase 1
sefulness of botulinum toxin type A in the treatment of chronic anal fissure
Dra. A. Teresa Calderón Duque0 sitesApril 7, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic anal fissure
- Sponsor
- Dra. A. Teresa Calderón Duque
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Patients seen in the clinical Surgery Consultation with diagnosis of chronic anal fissure.
- •\* Patients older than 18 years of age with a diagnostic of fissure of more than two months of evolution who have not responded to previous anal fissure medical treatments. Medical treatment would consist of hygienic dietary measures and systemic and local analgesic treatment with ointments (Annex 1\). These ointments will be either calcium antagonists (Diltiazem 2%) or nitrates (Rectogesic 0\.4%), whose main function is to relax the smooth muscle of the anus. This treatment should be prescribed for 6\-8 weeks before assessing whether or not there has been healing or improvement
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 50
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 50
Exclusion Criteria
- •\*Patients with diagnosis of chronic anal fissure that it isn’t idiopathic.
- •\* Patients who have not previously received medical treatment for the anal fissure.
- •\* Patients with contraindication to the use of Botulinum Toxin type A: Myasthenia gravis, Eaton\-Lambert syndrome, pregnant women, acelticoline deficiency.
Outcomes
Primary Outcomes
Not specified
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