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临床试验/NCT03589209
NCT03589209Unknown不适用

Preoperative CT Scan Analysis to Predict Perioperative Round Window Visibility Through the Posterior Tympanotoy in Cochlear Implant Surgery

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年6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
Measure of the correlation between preoperative CT measurements and the visibility of the round window observed intraoperatively (based on the operative records)

研究概览

简要总结

It is difficult to predict the intraoperative visibility of the round window through the posterior Tympanostomy. In case of non-visualization, the surgeon may have to change operative technique during cochlear implant surgery.

The primary purpose of the study is to define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window. Define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window.

The secondary purpose is to validate the investigator's scanner reading protocol for a prospective study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
9 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged subject from 9 months and over
  • Implanted cochlear subject in the ENT department of Strasbourg between 1st January 2010 and 1st March 2018
  • Subject (or the holders of parental authority in the case of minors) having agreed to the use of medical data for the purpose of this research.

排除标准

  • Refusal of the patient to participate in the study
  • CROP does not make it possible to evaluate the visibility of the FR
  • Preoperative or uninterpretable scanner
  • Major anatomical malformation
  • Subject under the protection of justice
  • Subject under guardianship or curatorship

结局指标

主要结局

Measure of the correlation between preoperative CT measurements and the visibility of the round window observed intraoperatively (based on the operative records)

时间窗: 1 day after cochlear implantation surgery

Analysis of patient records (operative reports and preoperative CT-scan) from patients who underwent cochlear implantation between 01/01/2010 and 01/03/2018.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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