Laryngeal Nerve Injuries, Thyroidectomy, Voice Change
Conditions
Keywords
External branch of the superior Laryngeal Nerve
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.
Interventions
intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification rate of EBSLN | during operation | Visual identification rate, Electrostimulatory identification rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Vocal outcome | up to postoperative 1 month, 3 months and 6 months | Visual Analogue Scales (VAS) \[0\ 100%\], 0% = no voice, full disability ; 100% = normal voice |
| Measurements of Vocal function | up to postoperative 1 month, 3 months and 6 months | Maximum Phonation Time (MPT) |
| Vocal evaluation | up to postoperative 1 month, 3 months and 6 months | GRBAS (Grade, Rough, Breathy, Asthenia, and Strain) |
| Change of results about questionnaire for quality of voice | up to postoperative 1 month, 3 months and 6 months | Voice Handicap Index-10 \[0\ 40\], higher scores mean worse voice disorder |
| Changes of Vocal outcome by Computerized Acoustic Analysis | up to postoperative 1 month, 3 months and 6 months | Multi-Dimensional Voice Program (MDVP) |
| Changes of Voice Pitch | up to postoperative 1 month, 3 months and 6 months | Real-time pitch (RTP) |
| Changes of Vocal fold vibration patterns | up to postoperative 1 month, 3 months and 6 months | EGG (electroglottography) assessment of voice |
Countries
South Korea
Contacts
Primary ContactHye Lim Bae, M.D
Outcome results
None listed