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AI-Assisted Written Information in Chronic Anal Fissure (AF-AI)

3. september 2026 opdateret af: Vedat Kaplan, Sanliurfa Education and Research Hospital

Effect of AI-Assisted Written Patient Information on Medical Treatment Adherence and Short-Term Patient-Reported Outcomes in Primary Chronic Anal Fissure: A Prospective Randomized Controlled Trial

This single-center, prospective, 1:1 randomized, parallel-group controlled superiority trial compares standard verbal counseling with AI-assisted written patient information in adults with primary chronic anal fissure receiving initial medical/conservative treatment. The primary objective is to determine whether AI-assisted written information improves complete treatment adherence at day 14. Secondary objectives include pain and discomfort outcomes, Patient Global Impression of Change, HEMO-FISS-QoL change, stool form change, additional healthcare visits, transition to interventional treatment, and patient satisfaction.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a single-center, prospective, 1:1 randomized, parallel-group, superiority-type controlled trial. Adult patients with primary chronic anal fissure for whom initial medical/conservative treatment is planned will be enrolled. Participants will be randomized in a 1:1 ratio to two groups. The control group will receive standardized verbal counseling, whereas the intervention group will receive AI-assisted written patient information containing the same medical content and pre-validated by the investigators. The medical treatment regimen will be identical in both groups, and the only difference will be the method of patient information delivery. Assessments will be performed face-to-face at baseline, by telephone on days 7 and 14, and face-to-face at week 6. The primary endpoint is complete treatment adherence at day 14. Secondary outcomes include changes in pain and discomfort at days 7 and 14 and week 6, PGI-C, change in HEMO-FISS-QoL score, change in stool form, additional healthcare visits, need for interventional treatment, and patient satisfaction.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

220

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AI-assisted written patient information
Participants receive standardized medical treatment plus AI-assisted written patient information that contains the same medical content as the verbal counseling and has been pre-validated by the investigators.
Adfærdsmæssigt: AI-assisted written patient information
Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.
Aktiv komparator: Standardized verbal counseling
Participants receive standardized medical treatment plus standardized verbal counseling alone.
Adfærdsmæssigt: Standardized verbal counseling
Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete treatment adherence at Day 14
Tidsramme: Day 14
Complete treatment adherence at Day 14, defined as a total adherence score of at least 5 out of 6 predefined treatment-behavior items: regular topical medication use, correct application to the target area, regular stool softener or fiber support, achievement of the water intake target, regular warm sitz bath or warm water application, and avoidance of excessive straining.
Day 14

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain during defecation at Day 7
Tidsramme: Day 7
Pain during defecation assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
Day 7
Pain during defecation at Day 14
Tidsramme: Day 14
Pain during defecation assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
Day 14
Pain during defecation at Week 6
Tidsramme: Week 6
Pain during defecation assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
Week 6
Patient Global Impression of Change at Day 7
Tidsramme: Day 7
Patient Global Impression of Change assessed on a 7-category ordinal scale: very much improved, much improved, a little improved, unchanged, a little worse, much worse, and very much worse.
Day 7
Patient Global Impression of Change at Week 6
Tidsramme: Week 6
Patient Global Impression of Change assessed on a 7-category ordinal scale: very much improved, much improved, a little improved, unchanged, a little worse, much worse, and very much worse.
Week 6

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanliurfa Education and Research Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juli 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SEAH-AF-AI

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared because this is a single-center study involving sensitive patient-level clinical data, and there is no pre-specified institutional mechanism for external data sharing. Only aggregated, de-identified study results will be reported.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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