AI-assisted written information to support treatment 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 is a single-center, prospective, randomized trial in adults with primary chronic anal fissure starting conservative treatment. Participants are randomized 1:1 to receive either standard verbal counseling or AI-assisted written information covering the same medical content. The study measures complete treatment adherence at day 14 as the primary endpoint, with secondary outcomes including pain, PGI-C, quality of life (HEMO-FISS-QoL), stool form, additional health visits, need for interventional treatment, and patient satisfaction. Assessments occur at baseline, by phone on days 7 and 14, and in person at week 6. The intervention and control differ only by the information delivery method; the medical treatment is identical across groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older
2. Clinical diagnosis of primary chronic anal fissure
3. Initial medical/conservative treatment planned at first evaluation
4. Ability to read and understand Turkish
5. Reachable by telephone
6. Provision of written informed consent

Exclusion Criteria:

1. Acute anal fissure
2. Suspicion or diagnosis of secondary fissure (including Crohn's disease, tuberculosis, HIV-related lesion, suspected malignancy, or atypical lateral fissure)
3. Planned botulinum toxin, surgery, or another interventional treatment
4. History of botulinum toxin or surgical treatment for anal fissure within the last 6 months
5. Concomitant perianal abscess, fistula, advanced hemorrhoidal disease, or another significant anorectal pathology
6. Pregnancy and early postpartum period

Where it's running

• Sanliurfa Education and Research Hospital
  Sanliurfa, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Vedat Kaplan
• Email: vedat_kaplan_@hotmail.com
• Phone: +905459045165

Similar studies

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

• 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.

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• 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

• 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

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

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

  Recruiting Islamabad Medical and Dental College · Islamabad, Federal · NCT07665528

• 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

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.