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NCT Number: NCT06002984

Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve in 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.

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Key information

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Su-jin Kim

CONTACT

[email protected]

Su-jin Kim

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Using Neuromonitoring to find EBSLN

Device

intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery

Primary outcomes

  1. Identification rate of EBSLN

    Time frame: during operation

    Visual identification rate, Electrostimulatory identification rate

Secondary outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Hye Lim Bae, M.D

CONTACT

[email protected]

82-10-2664-6571

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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