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临床试验/NCT01413802
NCT01413802已完成不适用

Intra Operative Continuous Laryngeal Nerve Monitoring During Thyroid Surgery and Interpretation of the Post-operative Voice Quality in Relation to the Electromyography Data Obtained During Surgery

University Hospital, Ghent3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
3
主要终点
Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery.

研究概览

简要总结

During thyroid surgery the laryngeal recurrent nerves (and for this reason the voice quality) are at risk. Therefore intra operative continuous neuromonitoring could help to prevent harm to these nerves. Electromyographic data (EMG values) are collected during surgery (1). In the postoperative follow-up period detailed voice analysis is performed (2): subjective auditive perceptive evaluation and videostroboscopy. Analysis and comparison of (1) and (2) will be performed in order to find out if we can find a predictive correlation between the EMG data (1) and the voice quality (2).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • patients (men/women) requiring thyroid surgery

排除标准

  • patients younger than 18 years, patients with preoperative vocal cord anatomical and functional anomalies.

结局指标

主要结局

Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery.

时间窗: 3 months after surgery

The primary outcome is to check if by continuous vagal nerve stimulation reversible damage to the recurrent laryngeal nerve can be foreseen, and therefore avoided. The detailed voice analysis that is used, consist of subjective auditive perceptive evaluation and videostroboscopy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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