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NCT Number: NCT07268261

Combined Method of Surgical Treatment of Anal Fissure

The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and ablebodied adults, so the issue of treatment is of particular relevance.

The main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure 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 postoperative period.

Botulinum Toxin Type A application in 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 with spasm of anal sphincter

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
  • Anal sphincter insufficiency
  • Chronic paraproctitis
  • Individual intolerance and hypersensitivity to botulinum toxin
  • Myasthenia gravis and myasthenic syndromes
  • History of allergic reaction to anticoagulants.
  • Blood diseases (thrombocytopenia, splenomegaly, etc.)

Treatment and study plan

excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A

Procedure

patients undergo excision of the fissure in combination with drug relaxation of the internal sphincter with botulinum toxin type A at a dosage of 40 units of action; an additional injection of platelet-rich plasma is added

Primary outcomes

  1. Anal sphincter insufficiency

    Time frame: 60 days

    Frequency of anal sphincter insufficiency according to the Wexner scale

Secondary outcomes

  1. 2-item pain intensity (P2)

    Time frame: On day 15, 30, 45 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 15, 30, 45, 60

    Frequency of post-operative wound epithelialization

  3. Profilometry /sphincterometry findings

    Time frame: On day 30, 60 and 365

    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.

Ekaterina Yu. Lebedeva

CONTACT

[email protected]

+79779558920

Evgeny E. Zharkov, MD

CONTACT

[email protected]

+79039689739

Sponsors and collaborators

Lead sponsor

State Scientific Centre of Coloproctology, Russian Federation

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

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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