Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve in Thyroid Surgery
- Conditions
- ThyroidectomyVoice ChangeLaryngeal Nerve Injuries
- Interventions
- Device: Using Neuromonitoring to find EBSLN
- Registration Number
- NCT06002984
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 94
- Patients who are scheduled to undergo thyroid surgery
- Patients who understand and agree to take part in this study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Using neuromonitoring to find EBSLN Using Neuromonitoring to find EBSLN With neuromonitoring of the EBSLN using nerve monitoring system Intervention Device: Neuromonitoring to find EBSLN
- Primary Outcome Measures
Name Time Method Identification rate of EBSLN during operation Visual identification rate, Electrostimulatory identification rate
- Secondary Outcome Measures
Name Time Method 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
Vocal evaluation up to postoperative 1 month, 3 months and 6 months GRBAS (Grade, Rough, Breathy, Asthenia, and Strain)
Changes of Vocal fold vibration patterns up to postoperative 1 month, 3 months and 6 months EGG (electroglottography) assessment of voice
Measurements of Vocal function up to postoperative 1 month, 3 months and 6 months Maximum Phonation Time (MPT)
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)
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of