Treatment options for chronic anal fissure
Official title: A Comparative Efficacy and Safety Study of Lateral Subcutaneous Sphincterotomy and Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure
Run by State Scientific Centre of Coloproctology, Russian Federation · NCT03855046 · Data updated 2026-11-12
This study tests whether using botulinum toxin after surgery can help people with chronic anal fissures heal better and avoid complications compared to a different surgical method.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 340 (estimated) |
| Sponsor | State Scientific Centre of Coloproctology, Russian Federation Government |
| Locations | 7 sites (Podolsk, Moscow Oblast and 6 other locations) |
| Status | Recruiting |
| Started | September 1, 2019 |
| Main results expected | September 1, 2022 |
| Study ends | November 1, 2022 |
| Registry record updated | January 27, 2022 |
| Trial ID | NCT03855046 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults diagnosed with chronic anal fissures who have not responded to non-surgical treatments.
✕Probably not a fit
Patients with inflammatory bowel diseases, severe hemorrhoids, or previous surgeries on the anal canal may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness and safety of using botulinum toxin compared to lateral subcutaneous sphincterotomy for treating chronic anal fissures. Chronic anal fissures are painful tears in the anal canal that persist for over two months and often do not respond to non-surgical treatments. The study aims to address the high rates of relapse associated with non-surgical methods and the complications of surgical treatments, particularly anal incontinence. By administering botulinum toxin after fissure excision, the study seeks to improve patient outcomes and reduce complications.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve healing for patients suffering from chronic anal fissures.
How similar studies have gone: Previous studies have shown promising results with botulinum toxin for anal fissures, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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GBUZ MO "Lvovskaia Raionaia Bolnica"
Podolsk, Moscow Oblast, Russia Recruiting -
Astrakhan State Medical University
Astrakhan, Russia Recruiting -
Medical Center ON-CLINIC
Moscow, Russia Recruiting -
SSCCRussia
Moscow, Russia Recruiting -
City Clinical Hospital №24, Department of Health City of Moscow
Moscow, Russia Recruiting -
St. Petersburg State Pavlov Medical University
Saint Petersburg, Russia Recruiting
Show 1 more location
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Siberian State Medical University
Tomsk, Russia Recruiting
Study contacts
- Principal investigator: Sergey A. Frolov, Ph.D. — State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)
- Study coordinator: Evgeny E. Zharkov, MD
- Email: drzharkov@mail.ru
- Phone: 89039689739
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.