NCT06801444 Comparison of Intr-operative Neuromonitoring Technique in Trans-oral Endoscopic Thyroidectomy Vestibular Approach
| NCT ID | NCT06801444 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China Medical University Hospital |
| Condition | Thyroidectomy |
| Study Type | OBSERVATIONAL |
| Enrollment | 304 participants |
| Start Date | 2023-03-29 |
| Primary Completion | 2025-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 304 participants in total. It began in 2023-03-29 with a primary completion date of 2025-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06801444 clinical trial?
This trial is open to participants of all sexes, studying Thyroidectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06801444 currently recruiting?
Yes, NCT06801444 is actively recruiting participants. Contact the research team at d84306@yahoo.com.tw for enrollment information.
Where is the NCT06801444 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT06801444 clinical trial?
NCT06801444 is sponsored by China Medical University Hospital. The trial plans to enroll 304 participants.