Seoul National University Hospital
Seoul, South Korea
Location status: Recruiting
NCT Number: NCT06002984
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.
Interested in participating?
Request Info19 year–79 year
All sexes
Interventional
Not applicable
Seoul, South Korea
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery
Time frame: during operation
Visual identification rate, Electrostimulatory identification rate
Time frame: up to postoperative 1 month, 3 months and 6 months
Voice Handicap Index-10 [0~40], higher scores mean worse voice disorder
Time frame: up to postoperative 1 month, 3 months and 6 months
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
Maximum Phonation Time (MPT)
Time frame: up to postoperative 1 month, 3 months and 6 months
GRBAS (Grade, Rough, Breathy, Asthenia, and Strain)
Time frame: up to postoperative 1 month, 3 months and 6 months
EGG (electroglottography) assessment of voice
Time frame: up to postoperative 1 month, 3 months and 6 months
Multi-Dimensional Voice Program (MDVP)
Time frame: up to postoperative 1 month, 3 months and 6 months
Real-time pitch (RTP)
Contact information is provided by the study sponsor or research team.
Seoul National University Hospital
Other
Effectiveness of Intraoperative Neuromonitoring to Identify and Preserve External Branch of Superior Laryngeal Nerve During Thyroid Surgery
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