340
Participants
Start Date
September 1, 2019
Primary Completion Date
September 1, 2022
Study Completion Date
November 1, 2022
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.
RECRUITING
Medical Center ON-CLINIC, Moscow
RECRUITING
SSCCRussia, Moscow
RECRUITING
"GBUZ MO Lvovskaia Raionaia Bolnica", Podolsk
RECRUITING
Astrakhan State Medical University, Astrakhan
RECRUITING
City Clinical Hospital №24, Department of Health City of Moscow, Moscow
RECRUITING
St. Petersburg State Pavlov Medical University, Saint Petersburg
RECRUITING
Siberian State Medical University, Tomsk
St. Petersburg State Pavlov Medical University
OTHER
Astrakhan State Medical University
OTHER
Siberian State Medical University
OTHER
City Clinical Hospital №24, Department of Health City of Moscow
OTHER_GOV
"GBUZ MO Lvovskaia Raionaia Bolnica"
OTHER_GOV
Medical Center ON-CLINIC
UNKNOWN
State Scientific Centre of Coloproctology, Russian Federation
OTHER_GOV