A Comparative Efficacy and Safety Study of Lateral Subcutaneous Sphincterotomy and Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure
Who is this study for? Patients with chronic anal fissure
What treatments are being studied? IncobotulinumtoxinA
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Patients with chronic anal fissure
Locations
Other Locations
Russian Federation
Astrakhan State Medical University
RECRUITING
Astrakhan
City Clinical Hospital №24, Department of Health City of Moscow
RECRUITING
Moscow
Medical Center ON-CLINIC
RECRUITING
Moscow
SSCCRussia
RECRUITING
Moscow
GBUZ MO Lvovskaia Raionaia Bolnica
RECRUITING
Podolsk
St. Petersburg State Pavlov Medical University
RECRUITING
Saint Petersburg
Siberian State Medical University
RECRUITING
Tomsk
Contact Information
Primary
Evgeny E. Zharkov, MD
drzharkov@mail.ru
89039689739
Backup
Roman Yu. Khryukin, MD
texnik.lip@yandex.ru
+79161598059
Time Frame
Start Date: 2019-09-01
Estimated Completion Date: 2022-11-01
Participants
Target number of participants: 340
Treatments
Experimental: Xeomin
Complex treatment of chronic anal fissure with drug-induced relaxation of the internal sphincter with Botulinum Toxin Type A. (IncobotulinumtoxinA 50 U Intramuscular Powder for Solution).
Active_comparator: Xeomin control
Complex treatment of chronic anal fissure with lateral subcutaneous sphincterotomy.
Related Therapeutic Areas
Sponsors
Collaborators: GBUZ MO Lvovskaia Raionaia Bolnica, Siberian State Medical University, City Clinical Hospital №24, Department of Health City of Moscow, Medical Center ON-CLINIC, Astrakhan State Medical University, St. Petersburg State Pavlov Medical University
Leads: State Scientific Centre of Coloproctology, Russian Federation