CompletedPhase 3

Low Versus High Dose OnabotulinumtoxinA for Chronic Anal Fissure

Egypt70 participantsStarted 2023-08-01

Plain-language summary

The goal of this clinical trial is to evaluate the efficacy of botulinum toxin injection in treatment of patients with chronic anal fissures comparing between two doses of botulinum toxin injection focusing on healing rate, fissure pain, incontinence and return to daily activity. patients will be divided into two groups group A) will receive 50IU from Botulinium toxin type A in the form of two injections at 3 o'clock and 9 o'clock without any anasthesia. While group B) will receive low dose injection in the form of 20IU by the same technique.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion Criteria: * Participants were required to have persistent symptoms despite standard first-line management. Exclusion Criteria: Exclusion criteria included atypical fissure location or appearance, such as lateral or multiple fissures; suspected secondary causes, including Crohn's disease, infection, tuberculosis, HIV-related ulceration, or malignancy; the presence of a perianal fistula or abscess; and contraindications or high-risk conditions for botulinum toxin treatment, including pregnancy, breastfeeding, known hypersensitivity to botulinum toxin products, active infection at the injection site, or significant neuromuscular junction disorders. \-

What they're measuring

pain reduction measured by visual analogue scale

Timeframe: 4 weeks

Trial details

NCT IDNCT07543315

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-30

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