Treatment of chronic anal fissure with ultrasound-guided intersphincteric infiltration of botulinum toxin A.

Phase 1

• Conditions: Chronic anal fissure; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2021-002819-60-ES
• Lead Sponsor: Hospital Universitario de Burgos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-23
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

All patients of legal age who sign the informed consent form and are diagnosed with chronic anal fissure will be included in the study. Chronic anal fissure will be considered as that which has been evolving for more than 6 weeks, in spite of various hygienic-dietary treatments and/or relaxants (NTG) or calcium blockers and which macroscopically presents some of the aspects of chronicity referred to: indurated edges, observation in the fundus of internal anal sphincter fibers and/or sentinel polyp persisting for more than 6 weeks.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients in whom botulinum toxin injection is contraindicated are excluded from the study: patients with alterations of neuromuscular transmission such as myasthenia gravis, Lambert Eaton myasthenic syndrome, inflammatory bowel disease, concomitant treatment with aminoglycosides, pregnancy or lactation, asthma or adverse reactions to treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified