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Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation

U

University of Bologna

Status and phase

Completed
Phase 2

Conditions

Thyroidectomy

Treatments

Procedure: thyroidectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01163045
2 - Cavicchi

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 patients

Sex

All

Ages

18 to 84 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

250 participants in 2 patient groups

neuromonitoring and neurostimulation
Experimental group
Treatment:
Procedure: thyroidectomy
neurostimulation of recurrent laryngeal nerve
Experimental group
Treatment:
Procedure: thyroidectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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