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

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Seoul National University

Status

Enrolling

Conditions

Laryngeal Nerve Injuries
Thyroidectomy
Voice Change

Treatments

Device: Using Neuromonitoring to find EBSLN

Study type

Interventional

Funder types

Other

Identifiers

NCT06002984
2303-075-1411

Details and patient eligibility

About

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.

Full 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.

Enrollment

94 estimated patients

Sex

All

Ages

19 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

94 participants in 2 patient groups

Using neuromonitoring to find EBSLN
Experimental group
Description:
With neuromonitoring of the EBSLN using nerve monitoring system Intervention Device: Neuromonitoring to find EBSLN
Treatment:
Device: Using Neuromonitoring to find EBSLN
No using neuromonitoring to find EBSLN
No Intervention group
Description:
Without neuromonitoring of the EBSLN using nerve monitoring system

Trial contacts and locations

1

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Central trial contact

Hye Lim Bae, M.D

Data sourced from clinicaltrials.gov

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