Combined surgical approach for chronic anal fissure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center interventional program tests a combined surgical approach for chronic anal fissure that pairs fissure excision with postoperative injection of botulinum toxin A to relax the internal anal sphincter. The rationale is that sphincter spasm underlies chronic fissures and that botulinum toxin may reduce postoperative sphincter hypertonia, lowering pain and the risk or duration of sphincter insufficiency. Participants are adults with chronic fissures and internal sphincter spasm who meet exclusion criteria such as inflammatory bowel disease, prior anal surgery, significant sphincter insufficiency, pregnancy, or contraindications to botulinum toxin. The study is conducted at the State Scientific Centre of Coloproctology in Moscow and uses surgical excision followed by botulinum toxin as the interventional protocol; outcomes likely include pain, healing, recurrence, and incontinence though specific endpoints are not listed in the registry entry.

Why it matters

Who can join: the full rules

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.)

Where it's running

• SSCCRussia
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: Sergey A. Frolov, Ph.D — State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)
• Study coordinator: Evgeny E. Zharkov, MD
• Email: drzharkov@mail.ru
• Phone: +79039689739

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.