Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation

July 14, 2010 updated by: University of Bologna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Italy/Bologna
      • Bologna, Italy/Bologna, Italy, 40100
        • Policlinico S.Orsola-Malpighi ENT Clini University of Bologna Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: neuromonitoring and neurostimulation
total thyroidectomy and lobectomy
Experimental: neurostimulation of recurrent laryngeal nerve
total thyroidectomy and lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
recurrent laryngeal nerve paralysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Ottavio O Cavicchi, MD, ENT Clinic Ploiclinico S.Orsola-Malpighi Bologna Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (Estimate)

July 15, 2010

Study Record Updates

Last Update Posted (Estimate)

July 15, 2010

Last Update Submitted That Met QC Criteria

July 14, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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