Complex Treatment of a Chronic Anal Fissure

Recruiting now · Phase 4

Conditions studied: Fissure in Ano

In brief

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

Key facts

Study ID

NCT03855046

Run by

State Scientific Centre of Coloproctology, Russian Federation

People needed

340

Starts

2019-09-01

Expected to finish

2022-11-01

Last updated by the study team

2022-01-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with chronic anal fissure

You may not qualify if…

• 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

Where it is running

• GBUZ MO "Lvovskaia Raionaia Bolnica" — Podolsk, Moscow Oblast, Russia (enrolling)
• Astrakhan State Medical University — Astrakhan, Russia (enrolling)
• Medical Center ON-CLINIC — Moscow, Russia (enrolling)
• SSCCRussia — Moscow, Russia (enrolling)
• City Clinical Hospital №24, Department of Health City of Moscow — Moscow, Russia (enrolling)
• St. Petersburg State Pavlov Medical University — Saint Petersburg, Russia (enrolling)
• Siberian State Medical University — Tomsk, Russia (enrolling)

Full record on ClinicalTrials.gov

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