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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
94
intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery
Seoul National University Hospital
Seoul, South Korea
RECRUITINGIdentification rate of EBSLN
Visual identification rate, Electrostimulatory identification rate
Time frame: during operation
Change of results about questionnaire for quality of voice
Voice Handicap Index-10 \[0\~40\], higher scores mean worse voice disorder
Time frame: up to postoperative 1 month, 3 months and 6 months
Changes of Vocal outcome
Visual Analogue Scales (VAS) \[0\~100%\], 0% = no voice, full disability ; 100% = normal voice
Time frame: up to postoperative 1 month, 3 months and 6 months
Measurements of Vocal function
Maximum Phonation Time (MPT)
Time frame: up to postoperative 1 month, 3 months and 6 months
Vocal evaluation
GRBAS (Grade, Rough, Breathy, Asthenia, and Strain)
Time frame: up to postoperative 1 month, 3 months and 6 months
Changes of Vocal fold vibration patterns
EGG (electroglottography) assessment of voice
Time frame: up to postoperative 1 month, 3 months and 6 months
Changes of Vocal outcome by Computerized Acoustic Analysis
Multi-Dimensional Voice Program (MDVP)
Time frame: up to postoperative 1 month, 3 months and 6 months
Changes of Voice Pitch
Real-time pitch (RTP)
Time frame: up to postoperative 1 month, 3 months and 6 months
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