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

Study Overview
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Brief Summary
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The paralysis of the external branch of superior laryngeal nerves after thyroid surgery is known to be a common complication resulting in poor quality of life. Aim of this randomized control trial(RCT) is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of these nerves.

Detailed Description
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The external branch of superior laryngeal nerves(EBSLNs) are important for voice quality. Injury to this nerve during thyroid surgery can manifest as ipsilateral paralysis of the cricothyroid muscle. Clinical symptoms may include: hoarseness, breathy voice, an increase in the rate of throat clearing, vocal fatigue, or diminished vocal frequency range, especially with regards to raising pitch. The amount of EBSLNs identified intraoperatively varies from 10% to 80%, while the rate of EBSLN injury reported in the literature is between 5% and 28%, depending on different evaluation methods. Advances in intraoperative neuromonitoring techniques would allow for EBSLN identification during thyroid surgery. However, there is controversy regarding usefulness in preserving EBSLN function using nerve monitoring system. The aim of the study is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of EBSLNs.

Official Title
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Effectiveness of Intraoperative Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroid Surgery

Conditions
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Carcinoma, Papillary, Follicular

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: planned open thyroidectomy acceptable clinical laboratory tests understand clinical trials no significant past medical history Exclusion Criteria: planned radical neck dissection hyperthyroidism history history of laryngeal nerve palsy laryngeal disease history uncontrolled hypertension or diabetes mellitus or heart disease anticoagulation or antiplatelet medication stroke history participated another clinical trials in 30days

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
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 | 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 of EBSLN during thyroid surgery | Identification rate of EBSLN | up to postoperative 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location of EBSLN | Classification of EBSLN according to Cernea classification | up to postoperative 12 months | 
| Vocal outcome | Voice assessment using voice lab | up to postoperative 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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superior laryngeal nerve