Complex Treatment of a Chronic Anal Fissure

PHASE4RecruitingINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

September 1, 2019

Primary Completion Date

September 1, 2022

Study Completion Date

November 1, 2022

Conditions
Fissure in Ano
Interventions
DRUG

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."

PROCEDURE

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.

Trial Locations (7)

119034

RECRUITING

Medical Center ON-CLINIC, Moscow

123423

RECRUITING

SSCCRussia, Moscow

142155

RECRUITING

"GBUZ MO Lvovskaia Raionaia Bolnica", Podolsk

Unknown

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

All Listed Sponsors
collaborator

St. Petersburg State Pavlov Medical University

OTHER

collaborator

Astrakhan State Medical University

OTHER

collaborator

Siberian State Medical University

OTHER

collaborator

City Clinical Hospital №24, Department of Health City of Moscow

OTHER_GOV

collaborator

"GBUZ MO Lvovskaia Raionaia Bolnica"

OTHER_GOV

collaborator

Medical Center ON-CLINIC

UNKNOWN

lead

State Scientific Centre of Coloproctology, Russian Federation

OTHER_GOV