Intraoperative neuromonitoring of the external branch of the superior laryngeal nerve during robotic thyroid surgery: a preliminary prospective study.
Su-Jin Kim, Kyu Eun Lee, Byung-Mo Oh...
https://pubmed.ncbi.nlm.nih.gov/26576402Actively Recruiting
Phase Not Applicable
Age: 19Years - 79Years
All Genders
ID06002984
Effectiveness of Intraoperative Neuromonitoring to Identify and Preserve External Branch of Superior Laryngeal Nerve During Thyroid Surgery
Led by Seoul National University Hospital · Updated on 2025-06-12
94
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
The trial investigates the frequent damage to the external branch of the superior laryngeal nerve (EBSLN) during thyroid surgery, a complication that can reduce quality of life by affecting voice pitch and projection. This randomized controlled trial evaluates whether using intraoperative neuromonitoring during thyroid surgery helps protect the EBSLN to maintain proper vocal cord function and voice quality. Participants will be randomly assigned to one of two groups: one undergoing thyroid surgery with neuromonitoring to identify and preserve the EBSLN, and the other undergoing surgery without this monitoring. The neuromonitoring device is used to confirm nerve presence and function before and after dissecting the upper thyroid pole. This approach aims to better preserve the cricothyroid muscle function, which controls vocal cord tension. During the study, participants' voice quality and vocal function will be assessed before and at 1, 3, and 6 months after surgery using questionnaires and computerized acoustic analysis. Researchers will measure the identification rate of the EBSLN during surgery as the primary outcome. The trial includes follow-up evaluations of vocal fold vibration patterns and voice pitch changes to monitor nerve preservation and voice performance, with participation lasting up to six months postoperatively.
CONDITIONS
Brief Title
Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve in Thyroid Surgery
Who Can Participate
Age: 19Years - 79Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients who are scheduled to undergo thyroid surgery
- Patients who understand and agree to take part in this study
You will not qualify if you...
- Thyroid tumor suspected to invade adjacent organs such as esophagus, trachea, carotid artery, or jugular vein
- Patients requiring lateral compartment neck dissection
- Patients with recurrent thyroid cancer
- Patients with past or present paralysis of recurrent laryngeal nerve or superior laryngeal nerve external branch
- Patients with a history of vocal cord and larynx disease
- History of hyperthyroidism, such as Graves' disease
- Taking anticoagulants like aspirin or warfarin before surgery
- Coagulation disorders
- Women who are pregnant or breastfeeding
- Patients judged inappropriate by the clinical trial researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day and immediate postoperative period
Participants undergo thyroid surgery during which intraoperative neuromonitoring may be used to identify and preserve the external branch of the superior laryngeal nerve.
1 visit (in-person, surgery day)
Post-operative Follow-up
Duration - Up to 6 months post-surgery
Participants are monitored for voice quality and vocal function at multiple time points after surgery to evaluate the effects of nerve preservation.
Visits at 1 month, 3 months, and 6 months postoperatively
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
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Research Team
H
Hye Lim Bae, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Efficacy of Intraoperative Neuromonitoring in Reoperation for Recurrent Thyroid Cancer Patients.
Jang-Il Kim, Su-Jin Kim, Zhen Xu...
https://pubmed.ncbi.nlm.nih.gov/33397044Normative intra-operative electrophysiologic waveform analysis of superior laryngeal nerve external branch and recurrent laryngeal nerve in patients undergoing thyroid surgery.
Andre S Potenza, Eimear A Phelan, Claudio R Cernea...
https://pubmed.ncbi.nlm.nih.gov/23838931Randomized controlled trial of visualization versus neuromonitoring of the external branch of the superior laryngeal nerve during thyroidectomy.
Marcin Barczyński, Aleksander Konturek, Małgorzata Stopa...
https://pubmed.ncbi.nlm.nih.gov/22402975Neuromonitoring of the external branch of the superior laryngeal nerve during thyroid surgery.
J Jonas, R Bähr
https://pubmed.ncbi.nlm.nih.gov/10827327Comparison of perioperative stress in patients undergoing thyroid surgery with and without neuromonitoring-a pilot study.
Dominika Babińska, Marcin Barczyński, Tomasz Osęka...
https://pubmed.ncbi.nlm.nih.gov/27299585Intraoperative neuromonitoring versus visual nerve identification for prevention of recurrent laryngeal nerve injury in adults undergoing thyroid surgery.
Roberto Cirocchi, Alberto Arezzo, Vito D'Andrea...
https://pubmed.ncbi.nlm.nih.gov/30659577Neuromonitoring and video-assisted thyroidectomy: a prospective, randomized case-control evaluation.
Gianlorenzo Dionigi, Luigi Boni, Francesca Rovera...
https://pubmed.ncbi.nlm.nih.gov/18806939A prospective, randomized trial of nerve monitoring of the external branch of the superior laryngeal nerve during thyroidectomy under local/regional anesthesia and IV sedation.
Jean-Christophe Lifante, Julie McGill, Thomas Murry...
https://pubmed.ncbi.nlm.nih.gov/19958945