Application of transoral continuous intraoperative neuromonitoring in natural orifice transluminal endoscopic surgery for thyroid disease: a preliminary study.
Han-Kun Chen, Chun-Liang Chen, Kuo-Shan Wen...
https://pubmed.ncbi.nlm.nih.gov/28643050Actively Recruiting
All Genders
ID06801444
Comparison of Intraoperative Neuromonitoring Techniques in Transoral Endoscopic Thyroidectomy Vestibular Approach
Led by China Medical University Hospital · Updated on 2025-01-30
304
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates different techniques of intraoperative neuromonitoring (IONM) used during transoral endoscopic thyroidectomy vestibular approach (TOETVA), a method that avoids visible scarring but carries risk of recurrent laryngeal nerve (RLN) injury. The study compares intermittent and continuous monitoring methods to evaluate their safety, effectiveness, and ability to detect nerve injury early during thyroid surgery. A new percutaneous continuous IONM technique using an external fixator was developed and is assessed against other methods. The study includes 304 patients who underwent TOETVA and were grouped based on the type of IONM used: percutaneous continuous, peroral intermittent, or continuous monitoring. The percutaneous continuous method involves a fixed stimulation probe to continuously monitor RLN function in real time, aiming to reduce nerve injury risk. Data collected include electrode setup time, operative time, stimulation intensity, and nerve palsy rates. Participants' age, sex, BMI, thyroid disease type, and operation details are recorded to compare outcomes between monitoring techniques. Researchers measure EMG signals from vocal cords, record occurrences of nerve palsy through laryngeal examination, and track electrode displacement during surgery. The study observes patients over approximately one year to assess the feasibility, safety, and effectiveness of each monitoring approach while monitoring nerve function continuously or intermittently during surgery.
CONDITIONS
Brief Title
Comparison of Intr-operative Neuromonitoring Technique in Trans-oral Endoscopic Thyroidectomy Vestibular Approach
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Benign solitary or multiple thyroid nodules, follicular lesions with largest diameter less than 6.0 cm
- Early papillary thyroid carcinoma less than 1 cm in diameter without cervical lymphadenopathy
You will not qualify if you...
- History of thyroid surgery
- History of neck radiotherapy
- History of recurrent laryngeal nerve paralysis
- Intraoperative conversion to conventional thyroidectomy
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 - Day of surgery
Participants undergo transoral endoscopic thyroidectomy vestibular approach with intraoperative neuromonitoring techniques while surgical and immediate postoperative data are collected.
1 visit (in-person)
Post-operative Follow-up
Duration - Up to 1 year
Participants are monitored for outcomes including nerve function and vocal cord mobility over an average of one year after surgery.
Follow-up visits as scheduled over one year
Trial Site Locations
Total: 1 location
1
China Medical University Hospital
Taichung, Taiwan, 404
Actively Recruiting
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Research Team
Y
Yih-Huei Uen, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
A new system for continuous recurrent laryngeal nerve monitoring.
Wolfram Lamadé, Christoph Ulmer, Andreas Seimer...
https://pubmed.ncbi.nlm.nih.gov/17573619Superiority of continuous over intermittent intraoperative nerve monitoring in preventing vocal cord palsy.
R Schneider, A Machens, C Sekulla...
https://pubmed.ncbi.nlm.nih.gov/34043775Efficacy of continuous neuromonitoring in thyroid surgery: preliminary report of a single-center experience.
Celestino Pio Lombardi, Chiara De Waure, Marco Mariani...
https://pubmed.ncbi.nlm.nih.gov/31538057Prospective study of vocal fold function after loss of the neuromonitoring signal in thyroid surgery: The International Neural Monitoring Study Group's POLT study.
Rick Schneider, Gregory Randolph, Gianlorenzo Dionigi...
https://pubmed.ncbi.nlm.nih.gov/26667156Stimulating dissecting instruments during neuromonitoring of RLN in thyroid surgery.
Feng-Yu Chiang, I-Cheng Lu, Pi-Ying Chang...
https://pubmed.ncbi.nlm.nih.gov/25809677Exclusive real-time monitoring during recurrent laryngeal nerve dissection in conventional monitored thyroidectomy.
Xiao-Li Liu, Che-Wei Wu, Yi-Shen Zhao...
https://pubmed.ncbi.nlm.nih.gov/27106003Complications of Transoral Thyroidectomy: Overview and Update.
Kyung Tae
https://pubmed.ncbi.nlm.nih.gov/33211953