NCT Number: NCT02886481
Electrophysiologic Study of Perioperative Monitoring of the Recurrent Laryngeal Nerve: Impaired Vocal Cord Movement After Thyroidectomy
Paralysis of the recurrent (or inferior) laryngeal nerve (RLN or ILN) is one of the most common and most serious complications of thyroid surgery. Neuromonitoring of the inferior laryngeal nerve (ILN or recurrent) is a technique currently used during thyroidectomy to locate ILN during dissection. Detector electrodes are placed in contact with vocal muscle which is stimulated electrically at the location of ILN, producing an acoustic and visual signal. This is a basic electromyographic technique whose diagnostic and prognostic potential for the entire neuromuscular system has not yet been fully explored. The study of action potentials generated by the stimulation-detection of nerves ILN and vagal nerves at the beginning and end of dissection, notably the decrease in amplitude, could allow a diagnosis during the course of surgery making it possible to diagnose lesions of the nerve and guide the surgeon in his surgical decisions, thus avoiding the risk of bilateral recurrent paralysis. It could also enable the surgeon to give a prognosis for functional recovery.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
CHU Amiens, Amiens, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients undergoing a total thyroidectomy or a thyroid lobectomy
Exclusion criteria
- History of mobility disorder of the vocal cords
Treatment and study plan
Primary outcomes
-
electrophysiologic state of the inferior laryngeal nerve
Time frame: Day 1
To study electrophysiologic state of the inferior laryngeal nerve with a neurostimulator during thyroidectomies in order to validate its diagnostic usefulness for ILN impairment of vocal cord movement.
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Other
Registry information
Acronym: NERLICORDE
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Sep 1, 2016
- Registry last updated
- Nov 30, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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