Complex Treatment of a Chronic Anal Fissure

Summary

This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.

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.

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University

  collaborator OTHER

• Astrakhan State Medical University

  collaborator OTHER

• Siberian State Medical University

  collaborator OTHER

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

  collaborator OTHER_GOV

• GBUZ MO "Lvovskaia Raionaia Bolnica"

  collaborator OTHER_GOV

• Medical Center ON-CLINIC

  collaborator UNKNOWN

• State Scientific Centre of Coloproctology, Russian Federation

  lead OTHER_GOV

Principal Investigators

• Sergey A. Frolov, Ph.D. · State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-01

Primary Completion

2022-09-01

Completion

2022-11-01

FDA Drug

Yes

Countries

• Russia

Study Locations