Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve in Thyroid Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Laryngeal Nerve Injuries, Thyroidectomy, Voice Change

Intervention / Treatment
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* Device: Using Neuromonitoring to find EBSLN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are scheduled to undergo thyroid surgery Patients who understand and agree to take part in this study Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Using neuromonitoring to find EBSLN<br>With neuromonitoring of the EBSLN using nerve monitoring system Intervention Device: Neuromonitoring to find EBSLN | Device: Using Neuromonitoring to find EBSLN<br>* intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery<br>|
| No Intervention: No using neuromonitoring to find EBSLN<br>Without neuromonitoring of the EBSLN using nerve monitoring system | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification rate of EBSLN | Visual identification rate, Electrostimulatory identification rate | during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of results about questionnaire for quality of voice | Voice Handicap Index-10 [0 40], higher scores mean worse voice disorder | 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 | up to postoperative 1 month, 3 months and 6 months | 
| Measurements of Vocal function | Maximum Phonation Time (MPT) | up to postoperative 1 month, 3 months and 6 months | 
| Vocal evaluation | GRBAS (Grade, Rough, Breathy, Asthenia, and Strain) | up to postoperative 1 month, 3 months and 6 months | 
| Changes of Vocal fold vibration patterns | EGG (electroglottography) assessment of voice | up to postoperative 1 month, 3 months and 6 months | 
| Changes of Vocal outcome by Computerized Acoustic Analysis | Multi-Dimensional Voice Program (MDVP) | up to postoperative 1 month, 3 months and 6 months | 
| Changes of Voice Pitch | Real-time pitch (RTP) | up to postoperative 1 month, 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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External branch of the superior Laryngeal Nerve