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Low Versus High Dose OnabotulinumtoxinA for Chronic Anal Fissure
Sponsor: Tanta University
Summary
This prospective single-center cohort study describes short-term and one-year clinical outcomes of two routine doses of OnabotulinumtoxinA (20 units versus 50 units) for chronic anal fissure refractory to conservative therapy. The dose was determined by each surgical unit's established routine practice and was not assigned by the investigators. Both doses were given as bilateral internal sphincter injections at the 3 and 9 o'clock positions in an equal 1-mL volume. The primary outcome is disease-specific quality of life (HEMO-FISS-QoL) at 1 month. Patients are followed for 12 months for pain, healing, continence, recurrence and need for lateral internal sphincterotomy.
Official title: Short-Term Clinical Outcomes of Two Routine Botulinum Toxin Regimens (20 Units Versus 50 Units of OnabotulinumtoxinA) for Chronic Anal Fissure: A One-Year Prospective Cohort Study
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2023-08-01
Completion Date
2026-08-30
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
OnabotulinumtoxinA
OnabotulinumtoxinA, 100-U vial reconstituted with preservative-free 0.9% saline, given as 1 mL into the internal anal sphincter (0.5 mL at 3 o'clock and 0.5 mL at 9 o'clock) without anesthesia. 20-U cohort: 20 U/mL (10 U per site). 50-U cohort: 50 U/mL (25 U per site). Dose determined by the treating unit's routine practice.
Locations (1)
Faculty of Medicine Tanta University
Tanta, Egypt