Status:
RECRUITING
Complex Treatment of a Chronic Anal Fissure
Lead Sponsor:
State Scientific Centre of Coloproctology, Russian Federation
Collaborating Sponsors:
St. Petersburg State Pavlov Medical University
Astrakhan State Medical University
Conditions:
Fissure in Ano
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.
Detailed Description
Chronic anal fissure is a rupture of anal canal mucosa lasting for more than 2 months and resistant to non-surgical treatment. This condition is attended by severe pain syndrome during and after bowel...
Eligibility Criteria
Inclusion
- Patients with chronic anal fissure
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT03855046
Start Date
September 1 2019
End Date
November 1 2022
Last Update
January 27 2022
Active Locations (7)
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1
GBUZ MO "Lvovskaia Raionaia Bolnica"
Podolsk, Moscow Oblast, Russia, 142155
2
Astrakhan State Medical University
Astrakhan, Russia
3
Medical Center ON-CLINIC
Moscow, Russia, 119034
4
SSCCRussia
Moscow, Russia, 123423