A Prospective Cohort Study for Machine Learning-Based Prediction of Anal Fistula Formation After Perianal Abscess Drainage Based on Drainage Setting, Provider Experience, and MRI Interpretation (PRISM)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 450
- 主要终点
- Fistula formation within 6 months
研究概览
简要总结
This prospective cohort study investigates the influence of provider experience and drainage location on fistula formation within 6 months following perianal abscess drainage. Additionally, the study explores the role of artificial intelligence (AI)-based interpretation of magnetic resonance (MR) images in early identification of fistula development.
详细描述
Perianal abscess drainage is a common surgical procedure. However, subsequent fistula formation remains a significant complication. This study aims to determine whether the procedure setting (operating room, emergency department, or outpatient clinic) and the experience level of the performing clinician affect fistula development rates.
Furthermore, the study evaluates the use of AI-assisted analysis of selected MR images to identify early signs of fistula formation. Selected image slices will be labeled based on radiological reports, and a machine learning model will be trained to predict fistula risk. The study will also compare AI-generated interpretations with expert radiologist assessments to validate performance.
The ultimate goal is to create a risk stratification tool to support clinical decision-making in surgical management of perianal abscesses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-time perianal abscess
- •Surgical drainage performed
排除标准
- •Existing anal fistula history
- •Crohn's disease
- •Immunosuppressive treatment
- •Incomplete 6-month follow-up
结局指标
主要结局
Fistula formation within 6 months
时间窗: 6 months
Confirmed by clinical exam, surgical findings, or MR imaging
次要结局
- Correlation between provider experience and fistula complexity(6 months)
- Diagnostic accuracy of AI-based MR analysis vs radiologist(6 months)
- Correlation between drainage location and fistula rate(6 months)
研究者
Kayahan Eyüboğlu
General Surgery Specialist
Gumushane State Hospital
