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Complex Treatment of a Chronic Anal Fissure

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 27, 2022 (before its estimated September 1, 2022 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study sites: 6 to 7v8
  2. Collaborators: 5 to 6v7
  3. Primary completion date: Sep 1, 2019 to Sep 1, 2022
    • Study completion date: Aug 20, 2022 to Nov 1, 2022
    v6
  4. Start date: Feb 20, 2019 to Sep 1, 2019v5 Show 4 more changesShow less
    • Study sites: 5 to 6
    • Study completion date: Feb 20, 2020 to Aug 20, 2022
    • Collaborators: 4 to 5
    • Eligibility criteria expanded, about 2 words
  5. 2 versions Re-verified since Apr 15, 2019, no change to tracked fieldsv3-v4
  6. Eligibility criteria revised
    • Secondary endpoints revised (5)
    • Publications revised (24)
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.
Trial Details
NCT Number NCT03855046
Lead Sponsor State Scientific Centre of Coloproctology, Russian Federation
Collaborators: St. Petersburg State Pavlov Medical University, Astrakhan State Medical University, Siberian State Medical University, City Clinical Hospital №24, Department of Health City of Moscow, GBUZ MO "Lvovskaia Raionaia Bolnica", Medical Center ON-CLINIC
Conditions
(from sponsor)		 Fissure in Ano
Related terms Fecal Incontinence, Fissure in Ano
Enrollment 340 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov