Comparing two methods to prevent nerve injury during thyroid surgery
Clinical Validation of NerveTrend vs. NerveAssure Mode of Intraoperative Neuromonitoring in Prevention of Recurrent Laryngeal Nerve Injury During Thyroid Surgery: A Randomized Controlled Trial
This study is testing whether two different methods of monitoring nerves during thyroid surgery can help prevent voice problems by seeing which one works better at protecting the recurrent laryngeal nerve.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Jagiellonian University Academic / other |
| Locations | 1 site (Krakow) |
| Trial ID | NCT06289309 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two intraoperative neuromonitoring modes, NerveTrend and NerveAssure, in preventing recurrent laryngeal nerve (RLN) injuries during bilateral thyroid surgery. It is a prospective, randomized trial involving 132 patients and 264 nerves at risk, assessing the prevalence of RLN injury on postoperative day 1 through direct laryngoscopy. The hypothesis is that NerveTrend may be as effective as NerveAssure in identifying potential nerve injuries and predicting postoperative vocal fold function, especially in resource-limited settings. The study seeks to provide insights into the practical application of these neuromonitoring techniques in surgical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who are scheduled for their first bilateral thyroid surgery.
Not a fit: Patients who have had previous thyroid surgery, are undergoing unilateral surgery, or have significant health issues (ASA 4-5 grade) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced nerve injuries for patients undergoing thyroid surgery.
How similar studies have performed: While there have been conflicting results in previous studies on intraoperative neuromonitoring, this approach is considered a novel alternative that may enhance surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * planned, first-time, bilateral thyroid surgery Exclusion Criteria: * planned unilateral thyroid surgery, * previous thyroid surgery, * pregnancy * lactation * age \< 18 years * age \> 75 years * ASA 4-5 grade (American Society of Anesthesiology) * inability to comply with the follow-up protocol
Where this trial is running
Krakow
- Department of Endocrine Surgery, Jagiellonian University College of Medicine — Krakow, Poland (Recruiting)
Study contacts
- Principal investigator: Marcin Barczynski, MD, PhD — Department of Endocrine Surgery, Jagiellonian University College of Medicine
- Study coordinator: Marcin Barczynski, MD, PhD
- Email: marbar@mp.pl
- Phone: +48602375939
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.