Clinical trial NCT06002984: Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve in Thyroid Surgery
Official title: Effectiveness of Intraoperative Neuromonitoring to Identify and Preserve External Branch of Superior Laryngeal Nerve During Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laryngeal Nerve Injuries
Thyroidectomy
Voice Change
Keywords: External branch of the superior Laryngeal Nerve
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 94
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Identification rate of EBSLN
timeFrame: during operation
Secondary outcomes:
measure: Change of results about questionnaire for quality of voice
timeFrame: up to postoperative 1 month, 3 months and 6 months
measure: Changes of Vocal outcome
timeFrame: up to postoperative 1 month, 3 months and 6 months
measure: Measurements of Vocal function
timeFrame: up to postoperative 1 month, 3 months and 6 months
measure: Vocal evaluation
timeFrame: up to postoperative 1 month, 3 months and 6 months
measure: Changes of Vocal fold vibration patterns
timeFrame: up to postoperative 1 month, 3 months and 6 months
measure: Changes of Vocal outcome by Computerized Acoustic Analysis
timeFrame: up to postoperative 1 month, 3 months and 6 months
measure: Changes of Voice Pitch
timeFrame: up to postoperative 1 month, 3 months and 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Su-Jin Kim, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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