Clinical trial NCT06801444: Comparison of Intr-operative Neuromonitoring Technique in Trans-oral Endoscopic Thyroidectomy Vestibular Approach
Official title: Comparison of Intr-operative Neuromonitoring Technique in Trans-oral Endoscopic Thyroidectomy Vestibular Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroidectomy
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 304
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing transoral vestibular endoscopic total thyroidectomy.

Brief 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 criteria: 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 outcomes:
measure: Electrode set up time refers to the time (min) from endoscopic or percutaneous insertion of electrode to functional set up of neural stimulation
timeFrame: through study completion, an average of one year
measure: Operative time refers to the time (min) from incision wound making to complete wound closure
timeFrame: through study completion, an average of one year
measure: Times of intraoperative displacement of stimulator electrode refers to total number of electrode displacement resulting in abnormal EMG signal
timeFrame: through study completion, an average of one year
measure: Stimulation intensity refers to the level (mA) of stimulation current used
timeFrame: through study completion, an average of one year
measure: Recurrent laryngeal nerve palsy refers to the presence of fixed or immobile vocal cord in laryngeal scopic examination
timeFrame: through study completion, an average of one year
measure: EMG signals refers to the amplitude (μV) and latency (ms) of biphasic EMG wave recorded from vocal cord with neural stimulation
timeFrame: through study completion, an average of one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
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