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临床试验/NCT03727217
NCT03727217已完成不适用

Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis After Thyroidectomy or Parathyroidectomy (PECV)

Lille Catholic University1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2018年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
113
试验地点
1
主要终点
Diagnostic performance comparison between ultrasound and nasofibroscopy

研究概览

简要总结

Thyroid and parathyroid surgery concerns around 50 000 patients a year in France. One of its main complications is paralysis of vocal cords, and the consequences can be serious.

In this study, the main gold is to evaluate diagnostic performances of ultrasound for an early diagnosis (as soon as awakening of the patient) of vocal cords paralysis in the post-operative period in order to prevent at best complications.

详细描述

Thyroid and parathyroid surgery concerns around 50 000 patients a year in France. One of its main complications is paralysis of vocal cords. Indeed, the anatomy of the thyroid and its close location with the recurrent laryngeal nerve (responsible for the vocal cord movement) involves a possible lesion or inflammation of the nerve during the surgical procedure. This complication is common, affecting around 10% of thyroid or parathyroid patients following surgery. This complication can be reversible, with a speech therapy or a specific endoscopic treatment by an otolaryngologist.

Currently, a postoperative screening is performed by nasofibroscopy in the recovery room to directly visualize vocal cord mobility. This examination may be painful or badly tolerated by some patients.

Recent studies have highlighted the performance of ultrasound in this diagnosis. The protocol for these studies included an ultrasound distant of the intervention, while it is known that vocal cord paralysis may have earlier consequences.

In this study, the investigators would like to evaluate diagnostic performances of vocal cords ultrasound for an early diagnosis (as soon as awakening of the patient) of vocal cords paralysis in the post-operative period in order to prevent at best complications.

The main limitation of vocal cord ultrasound is mainly related to surgery. Surgery creates anatomical rearrangements, so the secondary objective of this study will be to test whether the preoperative visualization is predictive of a good postoperative visualization.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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
否

入选标准

  • •Patients ≥ 18 years
  • •Scheduled surgery of total or partial thyroidectomy or parathyroidectomy
  • •Patient been informed and given his/her written consent to participate
  • •Patient affiliated to a social security scheme

排除标准

  • •Patient under tutorship or curatorship

研究组 & 干预措施

Pre and postoperative ultrasound

Experimental

An ultrasound is performed in preoperative and in postoperative.

干预措施: Pre and postoperative ultrasound (Diagnostic Test)

结局指标

主要结局

Diagnostic performance comparison between ultrasound and nasofibroscopy

时间窗: one hour after surgery

Diagnostic performances (sensitivity, specificity, positive and negative predictive value) of the immediate postoperative ultrasound (within one hour after the end of surgery), the gold standard being nasofibroscopy.

次要结局

  • Time for performing ultrasound(one hour after surgery)
  • Frequency distribution of quality of ultrasound visualization (good or bad) measured by contingency tables(before surgery (same day), one hour after surgery)

研究者

发起方
Lille Catholic University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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