About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who are scheduled to undergo thyroid surgery
Patients who understand and agree to take part in this study
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Using Neuromonitoring to find EBSLN
Deviceintraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery
Treatment groups
Trial outcomes
Primary outcomes
Identification rate of EBSLN
Visual identification rate, Electrostimulatory identification rate
Secondary outcomes
Change of results about questionnaire for quality of voice
Voice Handicap Index-10 \[0\~40\], higher scores mean worse voice disorder
Changes of Vocal outcome
Visual Analogue Scales (VAS) \[0\~100%\], 0% = no voice, full disability ; 100% = normal voice
Measurements of Vocal function
Maximum Phonation Time (MPT)
Vocal evaluation
GRBAS (Grade, Rough, Breathy, Asthenia, and Strain)
Sponsors and contacts
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