Complex Treatment of a Chronic Anal Fissure
ConditionFissure in Ano
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorState Scientific Centre of Coloproctology, Russian Federation
About this trial
This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.
Eligibility criteria
Qualifiers
Patients with chronic anal fissure
Disqualifiers
Inflammatory diseases of the colon
Pectenosis
Previous surgical interventions on the anal canal
IV grade internal and external hemorrhoids
Trial design
Treatments tested in this trial
- IncobotulinumtoxinA 50 U Intramuscular Powder for Solution
- Lateral subcutaneous sphincterotomy.
Treatment groups
340 Participants
are divided into 2 treatment groupsSponsors and collaborators
State Scientific Centre of Coloproctology, Russian Federation
Lead sponsor
St. Petersburg State Pavlov Medical University
Collaborator
Astrakhan State Medical University
Collaborator
Siberian State Medical University
Collaborator
City Clinical Hospital №24, Department of Health City of Moscow
Collaborator
GBUZ MO "Lvovskaia Raionaia Bolnica"
Collaborator
Medical Center ON-CLINIC
Collaborator
Source ClinicalTrials.gov