Combined Method of Surgical Treatment of Anal Fissure
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• • Patients with chronic anal fissure with spasm of anal sphincter
Locations
Other Locations
Russian Federation
SSCCRussia
RECRUITING
Moscow
Contact Information
Primary
Evgeny E. Zharkov, MD
drzharkov@mail.ru
+79039689739
Backup
Ekaterina Yu. Lebedeva
katerina.lebedeva.1997@mail.ru
+79779558920
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 122
Treatments
Experimental: main group
Patients of the main group undergo excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A (40 units, injection into the internal anal sphincter at 1, 5, 7 and 11 hours, 10 units each)
Experimental: control group
Patients in the control group undergo excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A (40 units, injection into the internal anal sphincter at 1, 5, 7 and 11 hours, 10 units each)
Related Therapeutic Areas
Sponsors
Leads: State Scientific Centre of Coloproctology, Russian Federation