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临床试验/NCT07019532
NCT07019532尚未招募不适用

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)

Gumushane State Hospital0 个研究点目标入组 450 人开始时间: 2025年7月1日最近更新:
适应症

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

发起方
Gumushane State Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Kayahan Eyüboğlu

General Surgery Specialist

Gumushane State Hospital

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