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RECRUITING
NCT03855046
PHASE4

Complex Treatment of a Chronic Anal Fissure

Sponsor: State Scientific Centre of Coloproctology, Russian Federation

View on ClinicalTrials.gov

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

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.

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