Chronic Anal FissureAF-AINCT07701811
AI-Assisted Written Information in Chronic Anal Fissure
A study testing AI-assisted written patient information and Standardized verbal counseling in people with Chronic Anal Fissure, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Anal Fissure
- What is being tested?
- AI-assisted written patient information and Standardized verbal counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Clinical diagnosis of primary chronic anal fissure
- Initial medical/conservative treatment planned at first evaluation
- Ability to read and understand Turkish
- Reachable by telephone
- Provision of written informed consent
Who cannot join
- Acute anal fissure
- Suspicion or diagnosis of secondary fissure (including Crohn's disease, tuberculosis, HIV-related lesion, suspected malignancy, or atypical lateral fissure)
- Planned botulinum toxin, surgery, or another interventional treatment
- History of botulinum toxin or surgical treatment for anal fissure within the last 6 months
- Concomitant perianal abscess, fistula, advanced hemorrhoidal disease, or another significant anorectal pathology
- Pregnancy and early postpartum period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sanliurfa Education and Research Hospital
Sanliurfa
Vedat Kaplan, +905459045165, vedat_kaplan_@hotmail.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Chronic Anal Fissure
- Being tested
- AI-assisted written patient information, Standardized verbal counseling
- Keywords
- Anal fissure, Chronic anal fissure, Treatment adherence, AI-assisted patient information, HEMO-FISS-QoL, PGI-C, Conservative treatment
- Medical subject headings
- Fissure in Ano, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted written patient informationBehavioural
Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.
Standardized verbal counselingBehavioural
Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted written patient information | Experimental | 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. Receives: Behavioral: AI-assisted written patient information |
| Standardized verbal counseling | Active comparator | Participants receive standardized medical treatment plus standardized verbal counseling alone. Receives: Behavioral: Standardized verbal counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete treatment adherence at 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.
Measured: Day 14
Secondary outcomes (5)
Pain during defecation at 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.
Measured: Day 7
Pain during defecation at 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.
Measured: Day 14
Pain during defecation at 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.
Measured: Week 6
Patient Global Impression of Change at 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.
Measured: Day 7
Patient Global Impression of Change at 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.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start15 Jul 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Anal FissureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to either standardized verbal counseling or AI-assisted written patient information in a parallel-group design.
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vedat Kaplan, Sanliurfa Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701811
- Sponsor's protocol ID
- SEAH-AF-AI
- Acronym
- AF-AI
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07701811
- Acronym / sponsor ID
- AF-AI / SEAH-AF-AI
- Conditions
- Chronic Anal Fissure
- Keywords
- Anal fissure, Chronic anal fissure, Treatment adherence, AI-assisted patient information, HEMO-FISS-QoL, PGI-C, Conservative treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Sanliurfa Education and Research HospitalOther government
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to either standardized verbal counseling or AI-assisted written patient information in a parallel-group design.
| Arm | Type | Receives |
|---|---|---|
| AI-assisted written patient information | Experimental | Behavioral: AI-assisted written patient informationParticipants 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. |
| Standardized verbal counseling | Active comparator | Behavioral: Standardized verbal counselingParticipants receive standardized medical treatment plus standardized verbal counseling alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Clinical diagnosis of primary chronic anal fissure
- Initial medical/conservative treatment planned at first evaluation
- Ability to read and understand Turkish
- Reachable by telephone
Key exclusion criteria (6 listed)
- Acute anal fissure
- Suspicion or diagnosis of secondary fissure (including Crohn's disease, tuberculosis, HIV-related lesion, suspected malignancy, or atypical lateral fissure)
- Planned botulinum toxin, surgery, or another interventional treatment
- History of botulinum toxin or surgical treatment for anal fissure within the last 6 months
- Concomitant perianal abscess, fistula, advanced hemorrhoidal disease, or another significant anorectal pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-assisted written patient informationInvestigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment. | Behavioural | AI-assisted written patient information |
| Standardized verbal counselingStandardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment. | Behavioural | Standardized verbal counseling |
Primary outcome
Complete treatment adherence at Day 14
Time frame: 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.
5 secondary outcomes
Pain during defecation at Day 7
Time frame: Day 7
Pain during defecation at Day 14
Time frame: Day 14
Pain during defecation at Week 6
Time frame: Week 6
Patient Global Impression of Change at Day 7
Time frame: Day 7
Patient Global Impression of Change at Week 6
Time frame: Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted written patient information and Standardized verbal counseling in people with Chronic Anal Fissure, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vedat Kaplan (+905459045165, vedat_kaplan_@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete treatment adherence at Day 14 (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.