跳至主要内容
临床试验/NCT04541238
NCT04541238Unknown不适用

Imaging Template for Reporting Anal Fistula

Treviso Regional Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Effectiveness of the novel template compared to standard reporting based on the number of key descriptors

研究概览

简要总结

Magnetic resonance imaging (MRI) is the most used diagnostic tool for pre-operative assessment of anal fistula.

However, there is lack of standardization in reporting this investigation. Moreover, reports may miss a number of key information for surgical planning.

The aim of this study is to assess the effectiveness, reproducibility, and acceptability of a new template for reporting anal fistula, which may favor standardization in clinical practice and inform surgical decision making.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with primary anal fistula (cryptoglandular or Crohn-related) undergoing MRI

排除标准

  • Active cancer of the anorectum
  • Recto-vaginal fistula

结局指标

主要结局

Effectiveness of the novel template compared to standard reporting based on the number of key descriptors

时间窗: 60 days

次要结局

  • Inter-rater agreement between two independent experienced radiologists using the novel template(7 days)
  • Qualitative analysis(30 days)

研究者

发起方
Treviso Regional Hospital
申办方类型
Network
责任方
Principal Investigator
主要研究者

Ugo Grossi

Colorectal Surgeon

Treviso Regional Hospital

研究点 (1)

Loading locations...

相似试验

Imaging Template for Reporting Anal Fistula | 临床试验