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

June 9, 2025 updated by: Su-jin Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Su-jin Kim, M.D, Ph.D, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 10, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 9, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2303-075-1411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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