AI-Assisted Written Information in Chronic Anal Fissure (AF-AI)
2026年9月3日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
220
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Vedat Kaplan
- 电话号码：+905459045165
- 邮箱：vedat_kaplan_@hotmail.com
学习地点
-
-
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Sanliurfa、土耳其（türkiye）
- 招聘中
- Sanliurfa Education and Research Hospital
-
接触：
- Vedat Kaplan
- 电话号码：+905459045165
- 邮箱：vedat_kaplan_@hotmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
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Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.
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有源比较器：Standardized verbal counseling
Participants receive standardized medical treatment plus standardized verbal counseling alone.
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Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Complete treatment adherence at Day 14
大体时间：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.
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Day 14
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain during defecation at Day 7
大体时间：Day 7
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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.
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Day 7
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Pain during defecation at Day 14
大体时间：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.
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Day 14
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Pain during defecation at Week 6
大体时间：Week 6
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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.
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Week 6
|
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Patient Global Impression of Change at Day 7
大体时间：Day 7
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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.
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Day 7
|
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Patient Global Impression of Change at Week 6
大体时间：Week 6
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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.
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Week 6
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月15日
初级完成 (估计的)
2026年12月31日
研究完成 (估计的)
2026年12月31日
研究注册日期
首次提交
2026年7月8日
首先提交符合 QC 标准的
2026年7月8日
首次发布 (实际的)
2026年7月14日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月3日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- SEAH-AF-AI
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.