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Electrophysiologic Study of Perioperative Monitoring of the Recurrent Laryngeal Nerve: Impaired Vocal Cord Movement After Thyroidectomy

NCT ID: NCT02886481

Last Updated: 2016-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Recurrent Laryngeal Nerve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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perioperative monitoring

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing a total thyroidectomy or a thyroid lobectomy

Exclusion Criteria

* History of mobility disorder of the vocal cords
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vladimir STRUNSKI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status

CHU Nimes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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PI2013_843_0013

Identifier Type: -

Identifier Source: org_study_id

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