NCT03855046 Complex Treatment of a Chronic Anal Fissure
| NCT ID | NCT03855046 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | State Scientific Centre of Coloproctology, Russian Federation |
| Condition | Fissure in Ano |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2019-09-01 |
| Primary Completion | 2022-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 340 participants in total. It began in 2019-09-01 with a primary completion date of 2022-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.
Eligibility 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
Contact & Investigator
Sergey A. Frolov, Ph.D.
PRINCIPAL INVESTIGATOR
State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)
Frequently Asked Questions
Who can join the NCT03855046 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Fissure in Ano. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03855046 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03855046 currently recruiting?
Yes, NCT03855046 is actively recruiting participants. Contact the research team at drzharkov@mail.ru for enrollment information.
Where is the NCT03855046 trial being conducted?
This trial is being conducted at Podolsk, Russia, Astrakhan, Russia, Moscow, Russia, Moscow, Russia and 3 additional locations.
Who is sponsoring the NCT03855046 clinical trial?
NCT03855046 is sponsored by State Scientific Centre of Coloproctology, Russian Federation. The principal investigator is Sergey A. Frolov, Ph.D. at State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia). The trial plans to enroll 340 participants.