Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate if intraoperative neuromonitoring associated to neurostimulation of recurrent laryngeal nerve reduce the rate of recurrent laryngeal palsy respect to neurostimulation alone.

Detailed Description
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Anatomic and functional preservation of the recurrent laryngeal nerve is a key element of thyroid surgery. Surgical exposure and visual identification of the nerve during thyroid surgery has been shown to provide the best rates of normal postoperative vocal fold function. Nevertheless, identification of the nerve sometimes can be difficult in patients who are heavily scarred or who have undergone previous surgery. Moreover, an anatomical intact nerve does not always correlate with normal vocal fold function. So it is mandatory to identify the nerve and to establish its function. Two techniques are described to facilitate identification of the nerve and to test its function. One is the neurostimulation with laryngeal palpation which is an intermittent monitoring techniques that permits to evaluate the contraction of cricoarytenoid muscle (laryngeal twitch ) after stimulation of RLN or vagal nerve with an electric stimulator probe. More recently some authors have suggested a continuous intraoperative neuromonitoring which provide audio and visual feed back when the nerve is electrically or mechanically stimulated during thyroidectomy. However controversy remains as to whether intraoperative neuromonitoring confers any significant benefit in injury prevention of recurrent laryngeal nerve.

Official Title
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Intraoperative Neuromonitoring and Neurostimulation of the Recurrent Laryngeal Nerve Versus Neurostimulation Alone in Thyroid Surgery: a Randomized Clinical Trial

Conditions
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Thyroidectomy

Intervention / Treatment
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* Procedure: thyroidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mono or bilateral thyroid surgery Exclusion Criteria: Previous thyroid and parathyroid surgery Thyroidectomy with mono or bilateral neck dissection Extended thyroidectomy for locally advanced thyroid carcinoma Retrosternal goitre Minimally invasive thyroid surgery Preoperative palsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neuromonitoring and neurostimulation<br> | Procedure: thyroidectomy<br>* total thyroidectomy and lobectomy<br>|
| Experimental: neurostimulation of recurrent laryngeal nerve<br> | Procedure: thyroidectomy<br>* total thyroidectomy and lobectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent laryngeal nerve paralysis |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurostimulation, intraoperative neuromonitoring, recurrent laryngeal nerve, palsy of recurrent laryngeal nerve, RCT