Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation

Phase 2

Completed

• Conditions: Thyroidectomy
• Interventions: Procedure: thyroidectomy

• Registration Number: NCT01163045
• Lead Sponsor: University of Bologna

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-02
• Study Completion: 2010-01
• Status Verified: 2010-06
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-14
• Last Update Submitted: 2010-07-14
• Study First Posted: 2010-07-15
• Last Update Posted: 2010-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
neuromonitoring and neurostimulation	thyroidectomy	-
neurostimulation of recurrent laryngeal nerve	thyroidectomy	-

Primary Outcome Measures

Name	Time	Method
recurrent laryngeal nerve paralysis

Trial Locations

Locations (1)

Policlinico S.Orsola-Malpighi ENT Clini University of Bologna Italy; 🇮🇹 Bologna, Italy/Bologna, Italy