RecruitingPhase 4NCT03855046

Complex Treatment of a Chronic Anal Fissure

A Comparative Efficacy and Safety Study of Lateral Subcutaneous Sphincterotomy and Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure


Sponsor

State Scientific Centre of Coloproctology, Russian Federation

Enrollment

340 participants

Start Date

Sep 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

  • Patients with chronic anal fissure

Exclusion Criteria10

  • Inflammatory diseases of the colon
  • Pectenosis
  • Previous surgical interventions on the anal canal
  • IV grade internal and external hemorrhoids
  • Rectal fistula
  • Severe somatic diseases at the decompensation stage
  • Pregnancy and lactation
  • Individual intolerance and hypersensitivity to botulinum toxin
  • Myasthenia gravis and myasthenia-like syndromes
  • Anal sphincter insufficiency

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Interventions

DRUGIncobotulinumtoxinA 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.

PROCEDURELateral 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

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NCT03855046