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

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ClinicalTrials.gov Identifier: NCT06002984
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : December 7, 2023
Sponsor:
Information provided by (Responsible Party):
Su-jin Kim, Seoul National University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Laryngeal Nerve Injuries Thyroidectomy Voice Change Device: Using Neuromonitoring to find EBSLN Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Intraoperative Neuromonitoring to Identify and Preserve External Branch of Superior Laryngeal Nerve During Thyroid Surgery
Actual Study Start Date : November 24, 2023
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Identification rate of EBSLN [ Time Frame: during operation ]
    Visual identification rate, Electrostimulatory identification rate


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Measurements of Vocal function [ Time Frame: up to postoperative 1 month, 3 months and 6 months ]
    Maximum Phonation Time (MPT)

  4. Vocal evaluation [ Time Frame: up to postoperative 1 month, 3 months and 6 months ]
    GRBAS (Grade, Rough, Breathy, Asthenia, and Strain)

  5. Changes of Vocal fold vibration patterns [ Time Frame: up to postoperative 1 month, 3 months and 6 months ]
    EGG (electroglottography) assessment of voice

  6. 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)

  7. Changes of Voice Pitch [ Time Frame: up to postoperative 1 month, 3 months and 6 months ]
    Real-time pitch (RTP)


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06002984


Contacts
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Contact: Hye Lim Bae, M.D 82-10-2664-6571 gpfla1206@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Su-jin Kim       su.jin.kim.md@gmail.com   
Principal Investigator: Su-jin Kim         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Su-Jin Kim, M.D, Ph.D Seoul National University Hospital
More Information
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Publications:

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Responsible Party: Su-jin Kim, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT06002984    
Other Study ID Numbers: 2303-075-1411
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: December 7, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Su-jin Kim, Seoul National University Hospital:
External branch of the superior Laryngeal Nerve
Additional relevant MeSH terms:
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Laryngeal Nerve Injuries
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Injuries
Cranial Nerve Injuries
 Cranial Nerve Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries