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Recruiting Phase 4 NCT03855046
Complex Treatment of a Chronic Anal Fissure
Trial Parameters
Condition Fissure in Ano
Sponsor State Scientific Centre of Coloproctology, Russian Federation
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 340
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2019-09-01
Completion 2022-09-01
Interventions
IncobotulinumtoxinA 50 U Intramuscular Powder for SolutionLateral subcutaneous sphincterotomy.
Brief Summary
This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.
Eligibility Criteria
Inclusion Criteria: * Patients with chronic anal fissure Exclusion Criteria: * Inflammatory diseases of the colon * Pectenosis * Previous surgical interventions on the anal canal * IV grade internal and external hemorrhoids * Rectal fistula * Severe somatic diseases at the decompensation stage * Pregnancy and lactation * Individual intolerance and hypersensitivity to botulinum toxin * Myasthenia gravis and myasthenia-like syndromes * Anal sphincter insufficiency