跳至主要内容
临床试验/NCT03773120
NCT03773120终止不适用

Effectiveness of Intraoperative Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroid Surgery

Seoul National University Hospital2 个研究点 分布在 2 个国家目标入组 5 人开始时间: 2018年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
2
主要终点
Identification of EBSLN during thyroid surgery

研究概览

简要总结

The paralysis of the external branch of superior laryngeal nerves after thyroid surgery is known to be a common complication resulting in poor quality of life. Aim of this randomized control trial(RCT) is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of these nerves.

详细描述

The external branch of superior laryngeal nerves(EBSLNs) are important for voice quality. Injury to this nerve during thyroid surgery can manifest as ipsilateral paralysis of the cricothyroid muscle. Clinical symptoms may include: hoarseness, breathy voice, an increase in the rate of throat clearing, vocal fatigue, or diminished vocal frequency range, especially with regards to raising pitch. The amount of EBSLNs identified intraoperatively varies from 10% to 80%, while the rate of EBSLN injury reported in the literature is between 5% and 28%, depending on different evaluation methods. Advances in intraoperative neuromonitoring techniques would allow for EBSLN identification during thyroid surgery. However, there is controversy regarding usefulness in preserving EBSLN function using nerve monitoring system. The aim of the study is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of EBSLNs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • planned open thyroidectomy
  • acceptable clinical laboratory tests
  • understand clinical trials
  • no significant past medical history

排除标准

  • planned radical neck dissection
  • hyperthyroidism history
  • history of laryngeal nerve palsy
  • laryngeal disease history
  • uncontrolled hypertension or diabetes mellitus or heart disease
  • anticoagulation or antiplatelet medication
  • stroke history
  • participated another clinical trials in 30days

结局指标

主要结局

Identification of EBSLN during thyroid surgery

时间窗: up to postoperative 12 months

Identification rate of EBSLN

次要结局

  • Location of EBSLN(up to postoperative 12 months)
  • Vocal outcome(up to postoperative 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Su-jin Kim

Associate professor

Seoul National University Hospital

研究点 (2)

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