跳至主要内容
临床试验/NCT06002984
NCT06002984招募中不适用

Effectiveness of Intraoperative Neuromonitoring to Identify and Preserve External Branch of Superior Laryngeal Nerve During Thyroid Surgery

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2023年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
94
试验地点
1
主要终点
Identification rate of EBSLN

研究概览

简要总结

The frequent occurrence of impaired function in the external branch of the superior laryngeal nerves following thyroid surgery is recognized as a prevalent complication leading to a diminished quality of life. The objective of this randomized controlled trial (RCT) is to assess the efficacy of neuromonitoring during thyroid surgery in order to safeguard the integrity of these nerves.

详细描述

With increased interest in quality of life after thyroidectomy, preservation of proper vocal cord function and voice quality is an important issue in thyroid surgery. External branch of the superior laryngeal nerve (EBSLN) and recurrent laryngeal nerve (RLN) are crucial organs for innervation and integration of laryngeal muscular system. The EBSLN innervates the cricothyroid muscle (CTM), which is important in adjusting the tension and length of the vocal cords. Damage of the EBSLN leads to CTM dysfunction, resulting in difficulty with high pitch phonation and decreased pitch range and reduced voice projection, which are important for voice professionals. As the intraoperative neuromonitoring was utilized as an adjunctive and objective tool to confirm the nerve presence and integrity, application of the intraoperative neuromonitoring system to confirm EBSLN function pre- and post-dissection of the upper thyroid pole can be regarded as an effective method to preserve cricothyroid muscle function. However, it remains unclear whether there is any intraoperative neuromonitoring techniques-added value to the clinical outcome of thyroidectomy in terms of identification of EBSLN and preserved voice performance. Therefore, this study could provide strong evidence of the application of the intraoperative neuromonitoring during thyroid surgery to identify and preserve EBSLN function.

研究设计

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

入排标准

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

入选标准

  • Patients who are scheduled to undergo thyroid surgery
  • Patients who understand and agree to take part in this study

排除标准

  • If the thyroid tumor is suspected to invade adjacent organs (esophagus, trachea, carotid artery, jugular vein etc.)
  • Patients who are required with lateral compartment neck dissection
  • Patients with recurrent thyroid cancer
  • Patients with palsy of recurrent laryngeal nerve or superior laryngeal nerve external branch in the past or present
  • Patients with a history of vocal cord and larynx disease
  • History of hyperthyroidism (e.g., Graves' disease)
  • Taking anticoagulants (aspirin, warfarin, etc.) before surgery
  • Disorders of coagulation
  • In the case of women, pregnant women and breastfeeding patients
  • Patients judged inappropriate by clinical trial researcher

结局指标

主要结局

Identification rate of EBSLN

时间窗: during operation

Visual identification rate, Electrostimulatory identification rate

次要结局

  • Changes of Vocal outcome(up to postoperative 1 month, 3 months and 6 months)
  • Vocal evaluation(up to postoperative 1 month, 3 months and 6 months)
  • Changes of Vocal fold vibration patterns(up to postoperative 1 month, 3 months and 6 months)
  • Measurements of Vocal function(up to postoperative 1 month, 3 months and 6 months)
  • Change of results about questionnaire for quality of voice(up to postoperative 1 month, 3 months and 6 months)
  • Changes of Vocal outcome by Computerized Acoustic Analysis(up to postoperative 1 month, 3 months and 6 months)
  • Changes of Voice Pitch(up to postoperative 1 month, 3 months and 6 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 (1)

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