Complex Treatment of a Chronic Anal Fissure
RecruitingPhase 4NCT03855046
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.
Study details
- Official title
- A Comparative Efficacy and Safety Study of Lateral Subcutaneous Sphincterotomy and Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure
- Conditions
- Fissure in Ano
- Interventions
- Drug: IncobotulinumtoxinA 50 U Intramuscular Powder for Solution
- Procedure: Lateral subcutaneous sphincterotomy.
- Sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Collaborators
- St. Petersburg State Pavlov Medical University; Astrakhan State Medical University; Siberian State Medical University; City Clinical Hospital №24, Department of Health City of Moscow; GBUZ MO "Lvovskaia Raionaia Bolnica"; Medical Center ON-CLINIC
- Start date
- 2019-09-01
- Primary completion
- 2022-09-01
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- Russia
- Total sites listed
- 7
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03855046