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/26576402/Actively Recruiting
Led by Seoul National University Hospital · Updated on 2025-06-12
94
Participants Needed
1
Research Sites
N/A
Total Duration
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
Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve in Thyroid Surgery
H
Hye Lim Bae, M.D
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Seoul National University Hospital
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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