Status:
UNKNOWN
NerveTrend vs. i-IONM in Prevention of Recurrent Laryngeal Nerve Events During Bilateral Thyroid Surgery.
Lead Sponsor:
Marcin Barczynski
Conditions:
Thyroid Diseases
Surgery
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The aim of this study is to compare two distinct modes of NIM Vital application in thyroid surgery: i-IONM vs. NerveTrend mode with respect to prevalence of early postoperative RLN injury. The hypoth...
Detailed Description
Over the past two decades, intraoperative neural monitoring (IONM) has evolved into a mature risk minimization tool. Meta-analyses of studies, most of which were limited by poor study designs and the ...
Eligibility Criteria
Inclusion
- planned, first-time, bilateral thyroid surgery.
Exclusion
- planned unilateral thyroid surgery,
- previous thyroid surgery,
- pregnancy
- lactation
- age \< 18 years
- age \> 65 years
- ASA 4-5 grade (American Society of Anesthesiology)
- inability to comply with the follow-up protocol
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT04794257
Start Date
April 1 2021
End Date
March 31 2023
Last Update
May 4 2021
Active Locations (1)
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1
Department of Endocrine Surgery, Jagiellonian University College of Medicine
Krakow, Poland, 31-202