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

Recruiting

• Conditions: Thyroidectomy

• Registration Number: NCT06801444
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-29
• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-24
• Last Update Submitted: 2025-01-24
• Study First Posted: 2025-01-30
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-12-11
• Study Completion: 2025-12-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 304

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan