Complex Treatment of a Chronic Anal Fissure

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation
• Collaborators: Astrakhan State Medical University; City Clinical Hospital №24, Department of Health City of Moscow; GBUZ MO "Lvovskaia Raionaia Bolnica"; Medical Center ON-CLINIC; Siberian State Medical University; St. Petersburg State Pavlov Medical University
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA; Pharmaceutical Solutions

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