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临床试验/NCT01395134
NCT01395134已完成不适用

Randomized Controlled Trial of Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.

Jagiellonian University2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2009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
发起方
入组人数
210
试验地点
2
主要终点
The identification rate of the external branch of the superior laryngeal nerve.

研究概览

简要总结

Injury to the external branch of the superior laryngeal nerve (EBSLN) during thyroidectomy results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. It remains unclear if use of intraoperative nerve monitoring (IONM) can improve clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.

详细描述

Phonation changes following thyroidectomy have been reported in many investigations. They are considered to be multifactorial in origin and can be a consequence of laryngeal nerve injury or other events during thyroidectomy including arytenoids trauma after endotracheal intubation, cricothyroid dysfunction, strap muscle malfunction or lesion of the perithyroidal neural plexus, laryngotracheal fixation with impairment of vertical movement and psychological reaction to the operation. Injury to the external branch of the superior laryngeal nerve (EBSLN) can occur during the dissection and clamping of the superior thyroid vessels and the prevalence of this complication has been reported from 0.5% to 58%. This injury causes a complete paralysis of the cricothyroid muscle which results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. Intraoperative nerve monitoring (IONM) has gained widespread acceptance as an adjunct to the gold standard of visual nerve identification and this technique can be used to identify both the recurrent laryngeal nerve (RLN) and the EBSLN. However, it remains unclear if there is any IONM added-value to the clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • thyroid pathology qualified for first-time bilateral neck surgery in a female patient with small to moderate sized goiter (below 100 ml in volume).

排除标准

  • male gender,
  • previous neck surgery,
  • unilateral thyroid pathology eligible for unilateral lobectomy,
  • goiter volume above 100 ml,
  • preoperatively diagnosed RLN palsy,
  • abnormal preoperative voice assessment on GRBAS scale,
  • pregnancy or lactation,
  • age below 18 years,
  • high-risk patients ASA 4 grade (American Society of Anesthesiology),
  • inability to comply with the scheduled follow-up protocol.

结局指标

主要结局

The identification rate of the external branch of the superior laryngeal nerve.

时间窗: up to 6 months postoperatively

次要结局

  • Anatomical variability of the external branch of the superior laryngeal nerve according to Cernea classification.(up to 6 months postoperatively)
  • The changes in postoperative voice performance.(up to 6 months postoperatively)

研究者

发起方
Jagiellonian University
申办方类型
Other

研究点 (2)

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