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OpenTrials
Completed

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens, Amiens, France

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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

perioperative monitoring

Device

Primary outcomes

  1. 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.

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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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