Comparing neuromonitoring techniques during scarless thyroid surgery
Comparison of Intr-operative Neuromonitoring Technique in Trans-oral Endoscopic Thyroidectomy Vestibular Approach
This study is testing two different ways to monitor nerve function during a type of thyroid surgery to see which one better helps prevent nerve damage.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 304 (estimated) |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT06801444 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of different intraoperative neuromonitoring techniques used during transoral endoscopic thyroidectomy vestibular approach (TOETVA) to prevent recurrent laryngeal nerve injury. It compares intermittent intraoperative neuromonitoring (I-IONM) with a novel continuous intraoperative neuromonitoring (C-IONM) technique developed at the China Medical University Hospital. The study involves a retrospective analysis of 304 patients who underwent TOETVA, categorizing them based on the neuromonitoring technique used. The goal is to assess the impact of these techniques on patient outcomes, particularly nerve function preservation.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with benign thyroid nodules or early-stage papillary thyroid carcinoma who meet specific size criteria.
Not a fit: Patients with a history of thyroid surgery, neck radiotherapy, or recurrent laryngeal nerve paralysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nerve function preservation during thyroid surgeries, reducing the risk of complications for patients.
How similar studies have performed: While the use of continuous intraoperative neuromonitoring is relatively novel, similar approaches have shown promise in other surgical contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taichung
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
Study contacts
- Study coordinator: Yih-Huei Uen, MD
- Email: d84306@yahoo.com.tw
- Phone: 886-4-37061668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.