Treatment options for chronic anal fissure
A Comparative Efficacy and Safety Study of Lateral Subcutaneous Sphincterotomy and Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure
PHASE4 · State Scientific Centre of Coloproctology, Russian Federation · NCT03855046
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | State Scientific Centre of Coloproctology, Russian Federation (other gov) |
| Locations | 7 sites (Podolsk, Moscow Oblast and 6 other locations) |
| Trial ID | NCT03855046 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with chronic anal fissures who have not responded to non-surgical treatments.
Not a fit: Patients with inflammatory bowel diseases, severe hemorrhoids, or previous surgeries on the anal canal may not benefit from this study.
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 performed: Previous studies have shown promising results with botulinum toxin for anal fissures, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Podolsk, Moscow Oblast and 6 other locations
- 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)
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fissure in Ano, Internal sphincterotomy, Anal fissure, Chronic anal fissure, botulinum toxin A, proctologic diseases, surgical treatment, Chronic anal pain