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Recruiting Observational

Comparison of Intr-operative Neuromonitoring Technique in Trans-oral Endoscopic Thyroidectomy Vestibular Approach

NCT06801444 · tracked via the Priya Life Science Taiwan tracker
Phase
Observational
Started
2023-03-29
Last updated
2025-01-30

Condition(s) studied

Thyroidectomy

Study summary

Transoral endoscopic thyroidectomy vestibular approach (TOETVA) has the advantage of scarless cosmesis but has limitations of recurrent laryngeal nerve (RLN) palsy. Intermittent intraoperative neuromonitoring (I-IONM) techniques have been utilized during TOETVA to identify and map RLN to prevent RLN injury. However, the insult may still occur between two neural stimulations. Continuous intraoperative neuromonitoring (C-IONM) has been used in TOETVA to persistent stimulation of RLN. but only in our hospital. This rare use may be related to technical challenges. Recently, we successfully developed a novel technique of percutaneous C-IONM using an external fixator to secure the stimulation probe to steadily monitor the real-time functional status of RLN during the TOETVA. In this retrospective study, 304 patients undergone TOETVA were enrolled and divided according to the usage of IONM techniques into percutaneous or peroral intermittent and continuous groups. Patient's age, sex, BMI, thyroid disease, operation time, EMG signal and RLN palsy rate were compared to verified the feasibility, safety, and effectiveness of different IONM techniques. We hypothesized percutaneous C-IONM has the superiority in early detection of RLN injury and reducing of RLN palsy in TOETVA.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: Benign solitary or multiple thyroid nodules, follicular lesions (the largest diameter \<6.0 cm), and early papillary thyroid carcinoma (\<1 cm in diameter, without cervical lymphadenopathy) Exclusion Criteria: History of thyroid surgery, neck radiotherapy, and recurrent laryngeal nerve paralysis; intraoperative conversion to conventional thyroidectomy.

Primary outcome measure(s)

  • Electrode set up time refers to the time (min) from endoscopic or percutaneous insertion of electrode to functional set up of neural stimulation — through study completion, an average of one year
  • Operative time refers to the time (min) from incision wound making to complete wound closure — through study completion, an average of one year
  • Times of intraoperative displacement of stimulator electrode refers to total number of electrode displacement resulting in abnormal EMG signal — through study completion, an average of one year
  • Stimulation intensity refers to the level (mA) of stimulation current used — through study completion, an average of one year
  • Recurrent laryngeal nerve palsy refers to the presence of fixed or immobile vocal cord in laryngeal scopic examination — through study completion, an average of one year
  • EMG signals refers to the amplitude (μV) and latency (ms) of biphasic EMG wave recorded from vocal cord with neural stimulation — through study completion, an average of one year

Trial sites (1)

FacilityCityRegionStatus
China Medical University Hospital Taichung Taiwan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06801444 on ClinicalTrials.gov ↗ ← All trials in Taiwan