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Complex Treatment of a Chronic Anal Fissure
Sponsor: State Scientific Centre of Coloproctology, Russian Federation
Summary
This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.
Official title: A Comparative Efficacy and Safety Study of Lateral Subcutaneous Sphincterotomy and Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
340
Start Date
2019-09-01
Completion Date
2022-11-01
Last Updated
2022-01-27
Healthy Volunteers
No
Conditions
Interventions
IncobotulinumtoxinA 50 U Intramuscular Powder for Solution
Sparing surgical removal of fissure without internal sphincter incision is held under spinal anesthesia in surgical room at lithotomy position using electrocoagulation. After that Botulinum Toxin Type A is injected into the internal anal sphincter at 1, 5, 7 and 11 o'clock (localization of injection points), 10 U at each point (40 U in total). Botulinum toxin type A (a 50 U vial) is diluted with 1.0 ml of 0.9% saline solution.
Lateral subcutaneous sphincterotomy.
The patient is positioned on the table like for perineal lithotomy. After spinal anesthesia, the anal canal and then the surgical field are treated with 70% ethanol. Under the rectal speculum control, sparing surgical removal of fissure without internal sphincter incision is held using electrocoagulation.Then, in a 3 or 9 o'clock position, a narrow (eye) scalpel is inserted into the intersphincteric groove separating the external and internal sphincters, the scalpel blade is turned to the rectal lumen, and the internal sphincter is dissected up to the wall of the anal canal mucosa under the control of the finger inserted into the anal canal. After controlling hemostasis, the operation is ended with the introduction of the vent tube and hemostatic sponge.
Locations (7)
GBUZ MO "Lvovskaia Raionaia Bolnica"
Podolsk, Moscow Oblast, Russia
Astrakhan State Medical University
Astrakhan, Russia
Medical Center ON-CLINIC
Moscow, Russia
SSCCRussia
Moscow, Russia
City Clinical Hospital №24, Department of Health City of Moscow
Moscow, Russia
St. Petersburg State Pavlov Medical University
Saint Petersburg, Russia
Siberian State Medical University
Tomsk, Russia