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Complex Treatment of a Chronic Anal Fissure

RecruitingPhase 4Ages 18 Years - 70 YearsAllState Scientific Centre of Coloproctology, Russia…
NCT03855046 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • IncobotulinumtoxinA 50 U Intramuscular Powder for Solution
  • Lateral subcutaneous sphincterotomy.
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Where

7 sites
GBUZ MO "Lvovskaia Raionaia Bolnica"
Podolsk, Russia
Astrakhan State Medical University
Astrakhan, Russia
Medical Center ON-CLINIC
Moscow, Russia
SSCCRussia
Moscow, Russia
City Clinical Hospital №24, Department of Health City of Moscow
Moscow, Russia
St. Petersburg State Pavlov Medical University
Saint Petersburg, Russia
Siberian State Medical University
Tomsk, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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