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NCT Number: NCT03855046

Complex Treatment of a Chronic Anal Fissure

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GBUZ MO "Lvovskaia Raionaia Bolnica", Podolsk, Moscow Oblast, Russia

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About this study

Chronic anal fissure is a rupture of anal canal mucosa lasting for more than 2 months and resistant to non-surgical treatment. This condition is attended by severe pain syndrome during and after bowel movement (defecation). This condition is most frequent in younger and working-age adults; therefore, the treatment issue is of particular relevance.

The main cause of chronic anal fissure development is spasm of the internal sphincter. It should be eliminated in the first instance, in order to provide the effective therapy. All the main treatment methods, such as medicinal relaxation of the internal sphincter with 0.4% nitroglycerin ointment, lateral subcutaneous sphincterotomy, and pneumodivulsion of the anal sphincter are aimed at its removal. However, the optimal method has not yet been developed.

Non-surgical treatments are often attended by relapse of disease, while surgical treatment is often complicated by intestinal contents incontinence, usually gas and loose or hard stool in some occasions (grade 3 anal sphincter insufficiency).

In particular, lateral subcutaneous sphincterotomy performed in such patients is associated with an increase in the degree of anal incontinence in the early post-operative period.

Botulinum Toxin Type A application in complex treatment of patients with chronic anal fissure (after fissure excision) is intended to improve the therapy results, namely to reduce the frequency and duration of anal sphincter insufficiency after sphincter spasm removal (reduction in the number of patients suffering from post-operative incontinence).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic anal fissure

Exclusion criteria

  • 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

Treatment and study plan

IncobotulinumtoxinA 50 U Intramuscular Powder for Solution

Drug

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.

Other names: Xeomin

Lateral subcutaneous sphincterotomy.

Procedure

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.

Primary outcomes

  1. Anal sphincter insufficiency

    Time frame: Up to 60 days

    Frequency of anal sphincter insufficiency according to the Wexner scale incontinence after the surgical intervention. Self reported daily meausure outcome, wich evaluate from 0 - to 20 points (where 0 points = full feacal continence; 20 points = full feacal incontinence).

Secondary outcomes

  1. 2-item pain intensity (P2)

    Time frame: On day 7, 30 and 60

    Self reported pain intensity after the defecation and during the day after the surgical intervention. Each item is scored 0-10 (0 = no pain; 10 = pain as bad, as can can be).

  2. Non-Healing Wound

    Time frame: On day 60

    Frequency of post-operative wound epithelialization

  3. Profilometry /sphincterometry findings

    Time frame: On day 30 and 60

    Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry

  4. Temporary disability

    Time frame: Up to 60 days

    Duration of temporary disability

  5. Relap

    Time frame: Up to 60 days

    Frequency of relapses

Study contacts

Contact information is provided by the study sponsor or research team.

Evgeny E. Zharkov, MD

CONTACT

[email protected]

89039689739

Roman Yu. Khryukin, MD

CONTACT

[email protected]

+79161598059

Sponsors and collaborators

Lead sponsor

State Scientific Centre of Coloproctology, Russian Federation

Other Gov

Collaborators

  • Astrakhan State Medical University
  • City Clinical Hospital №24, Department of Health City of Moscow
  • GBUZ MO "Lvovskaia Raionaia Bolnica"
  • Medical Center ON-CLINIC
  • Siberian State Medical University
  • St. Petersburg State Pavlov Medical University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2019
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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