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临床试验/NCT03950375
NCT03950375已完成不适用

Round Window Visibility Prediction From Preoperative Scanner in Cochlear Implantation: Literature Review and Radiologic Criteria Evaluation

CHU de Reims1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
23
试验地点
1
主要终点
peroperative round window exposure

研究概览

简要总结

The aim of the study is to identify the scannographic criterion the most relevant to predict the round window visibility during cochlear implantation.

详细描述

Whereas several surgical techniques exist to perform a cochlear implantation, the most used is the realization of mastoidectomy followed by posterior tympanotomy, in order to expose the round window, which finally permits to access to the cochlea. This procedure might be complicated with facial paresis, loss of residual hearing, because of anatomy relationships in this millimetric area.

CT scan of temporal bone is part of systematic preoperative assessment. Technological advances in radiology during the last decades now provide inframillimetric resolution. Thus, otologic surgeons wish they could anticipate round window exposure from these CT scan. This could decrease the procedure duration, complication occurrence, or improve surgical strategy.

Several studies proposed radiological criteria in this aim, from more or less complex measures in preoperative temporal bone CT scan. However, these diagnostic tests performances have not been assessed for most of them, or compared between them.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

peroperative round window exposure

时间窗: Day 0

peroperative round window exposure evaluated according to St Thomas' Hospital classification: * visible (classes I and II) and not visible (class III) * easily visible (classes I and IIa) and not easily visible (class IIb and III)

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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