Effect of Reversed Tracking Method for Identification of EBSLN in Thyroid Surgery

Study Overview
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Brief Summary
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The feasibility and effectiveness of Reversed Tracking Method for the identification and protection of extralaryngeal nerve branches in thyroid surgery were analyzed. Evidence-based medical evidence was used to evaluate the importance of EBSLN recognition and protection in thyroid surgery.

Detailed Description
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The incidence of thyroid cancer in the world is growing rapidly. The current incidence of thyroid cancer in China is about 4.2/100,000, ranking the fourth in the incidence of female malignant tumors. Surgical treatment is the first and most important treatment for thyroid cancer. According to the existing literature, the injury rate of EBSLN in thyroid surgery can be as high as 58%. The quality of sound changes caused by EBSLN injury affects the quality of life of patients after surgery, and even affects the work and career of patients. therefore, seeking better EBSLN protection The method has great social and economic benefits.

Official Title
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Effect of Reversed Tracking Method of Stimulating Cricothyroid Muscles on the Identification and Protection of EBSLN in Thyroid Surgery

Conditions
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Thyroid Cancer, Recurrent Laryngeal Nerve Injuries

Intervention / Treatment
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* Procedure: Reversed Tracking Method


Participation Criteria
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Eligibility Criteria
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Inclusion criteria： thyroid papillary cancer patients thyroid adenoma patients tumor diameter less than 4cm patients who require only unilateral thyroid surgery as required by the guidelines Exclusion criteria: The upper pole tumor invades the anterior dorsum and may accumulate the area of the superior laryngeal nerve; Patients who have previously performed head and neck surgery; Preoperative laryngoscopy and sound assessment abnormalities or previous vocal cord surgery history; If there is a language or hearing impairment, the follow-up assessment cannot be completed; The assessment failure of nerve function due to the technical deficiency of the IONM equipment Elimination criteria: Patients with recurrent laryngeal nerve palsy after surgery affect the evaluation of the laryngeal nerve. The patient is asked to withdraw from the follow-up assessment midway.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Interventional Model Description: Different methods of protection of external branches of superior laryngeal nerve
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard method<br>Standard method recommended by the guide | |
| Experimental: Reversed Tracking Method<br>Reversed Tracking Method | Procedure: Reversed Tracking Method<br>* Reversed Tracking Method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The identification rate of the external branch of the superior laryngeal nerve. | The identification rate of the external branch of the superior laryngeal nerve. | up to 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Friedman classification | Anatomical variability of the external branch of the superior laryngeal nerve according to Friedman classification. | up to 6 months postoperatively | 
| videostrobolaryngoscopy | The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale. | up to 6 months postoperatively | 
| analysis of maximum phonation time (MPT) | The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale. | up to 6 months postoperatively | 
| voice level (VL) | The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale. | up to 6 months postoperatively | 
| fundamental frequency (Fo) | The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale. | up to 6 months postoperatively | 
| voice quality rating on GRBAS scale | The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale. | up to 6 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroidectomy, thyroid cancer, external branches of superior laryngeal nerve