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Comparative Outcomes of Inj Botox Alone vs Inj Botox Combined With Fissurectomy and Anoplasty in the Management of Chronic Anal Fissure

RecruitingNAAges 18 Years - 65 YearsAllIslamabad Medical and Dental College
NCT07665528 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Chronic anal fissure is a common benign anorectal condition characterized by severe pain during defecation, rectal bleeding, and reduced quality of life. Injection Botox is a widely used sphincter-preserving treatment that produces temporary relaxation of the internal anal sphincter and promotes fissure healing. However, healing rates with injection Botox alone are variable and recurrence remains a concern. This prospective comparative trial aims to compare the effectiveness and safety of injection Botox alone versus injection Botox combined with fissurectomy and anoplasty in adults with chronic anal fissure. The study will evaluate healing rate, pain relief, time to healing, recurrence, postoperative complications, continence outcomes, and patient satisfaction. A total of 108 eligible patients with chronic anal fissure will be enrolled and allocated to one of the two treatment groups.

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📋 Eligibility rules (as published)
Inclusion Criteria: Adults aged 18 to 65 years, regardless of sex Diagnosis of chronic anal fissure persisting for more than 6 weeks Failure of at least 6 weeks of standardized conservative treatment Fit for anesthesia and surgical intervention Willing and able to provide written informed consent Exclusion Criteria: Acute anal fissure Inflammatory bowel disease Anal malignancy Previous anal surgery Pregnancy Pre-existing fecal incontinence Immunocompromised patients
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What it tests

  • Botulinum Toxin Type A (BOTOX) Injection
  • Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and Anoplasty
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Where

1 site
Islamabad Medical and Dental College
Islamabad, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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