Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Botox injections alone vs with fissurectomy and anoplasty for chronic anal fissure

Official title: Comparative Outcomes of Injection Botox Alone Versus Injection Botox Combined With Fissurectomy and Anoplasty in the Management of Chronic Anal Fissure

Run by Islamabad Medical and Dental College · NCT07665528 · Data updated 2026-11-12

This study tests whether adding fissurectomy and anoplasty to Botox injections helps healing and pain relief for adults with chronic anal fissure.

More Chronic Anal Fissure trials

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment108 (estimated)
SponsorIslamabad Medical and Dental College
Academic / other
Locations1 site (Islamabad, Federal)
StatusRecruiting
StartedJune 3, 2026
Main results expectedSeptember 3, 2026
Study endsDecember 3, 2026
Registry record updatedJune 26, 2026
Trial IDNCT07665528 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–65 with chronic anal fissure (>6 weeks) who failed at least 6 weeks of conservative therapy and are fit for anesthesia.

Probably not a fit

Patients who do not respond to Botox or who experience complications may not benefit from the combined approach.

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

What this trial studies

This prospective study compares two treatments for chronic anal fissure: Botox injections alone versus Botox injections plus fissurectomy and anoplasty. Adults 18–65 with fissures persisting more than 6 weeks and failure of conservative therapy are eligible. The trial will measure healing rate, pain relief, time to healing, recurrence, continence, and patient satisfaction, with 108 participants divided into the two groups and followed post-treatment. Outcomes will help determine if adding a surgical component to Botox provides better results without unacceptable risk. The study is conducted at Islamabad Medical and Dental College in Islamabad.

Why it matters

Potential benefit: If successful, patients could experience higher healing rates and longer-lasting relief with an approach that addresses both sphincter spasm and tissue healing.

How similar studies have gone: Prior Botox therapy has shown variable healing; combining with fissurectomy/anoplasty is a newer approach with limited, although promising, evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Islamabad Medical and Dental College
    Islamabad, Federal, Pakistan
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Ultrasound-based look at how much sphincter is cut during LIS for chronic anal fissure

    This study tests whether the amount of internal anal sphincter divided during lateral internal sphincterotomy affects healing and continence in adults with chronic anal fissure.

    Recruiting Hospital Clínico Universitario de Valencia · Valencia · NCT07809711

  • Improving recovery after surgery for benign anorectal conditions

    This study is testing if a special recovery plan can help people aged 18 to 65 have fewer problems with urinary retention after surgery for conditions like hemorrhoids and anal fissures.

    Recruiting Mansoura University · Al Mansurah · NCT06803550

  • AI-assisted written information to support treatment for chronic anal fissure

    This trial compares AI-assisted written information to standard verbal counseling to see if people with a chronic anal fissure better stick with initial medical treatment.

    Recruiting Sanliurfa Education and Research Hospital · Sanliurfa · NCT07701811

  • Three LIS techniques for chronic anal fissure healing

    This trial tests three different ways of performing lateral internal sphincterotomy to see which best heals chronic anal fissures with the least risk of incontinence.

    Recruiting Çanakkale Onsekiz Mart University · Çanakkale, Çanakkale · NCT07520552

  • Combined surgical approach for chronic anal fissure

    This trial tries removing the fissure and giving botulinum toxin A to relax the internal anal sphincter in people with chronic anal fissure to reduce pain, recurrence, and sphincter problems.

    Recruiting State Scientific Centre of Coloproctology, Russian Federation · Moscow · NCT07268261

  • Treatment for chronic anal fissures using E-CEL UVEC cells

    This study is testing if injections of special cells can help people with chronic anal fissures who haven't found relief from regular treatments.

    Recruiting Phase 1 Weill Medical College of Cornell University · New York, New York · NCT06456073

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.