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Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01163045
First Posted: July 15, 2010
Last Update Posted: July 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Bologna
  Purpose
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.

Condition Intervention Phase
Thyroidectomy Procedure: thyroidectomy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraoperative Neuromonitoring and Neurostimulation of the Recurrent Laryngeal Nerve Versus Neurostimulation Alone in Thyroid Surgery: a Randomized Clinical Trial

Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • recurrent laryngeal nerve paralysis

Enrollment: 250
Study Start Date: January 2008
Study Completion Date: January 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: neuromonitoring and neurostimulation Procedure: thyroidectomy
total thyroidectomy and lobectomy
Experimental: neurostimulation of recurrent laryngeal nerve Procedure: thyroidectomy
total thyroidectomy and lobectomy

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163045


Locations
Italy
Policlinico S.Orsola-Malpighi ENT Clini University of Bologna Italy
Bologna, Italy/Bologna, Italy, 40100
Sponsors and Collaborators
University of Bologna
Investigators
Study Director: Ottavio O Cavicchi, MD ENT Clinic Ploiclinico S.Orsola-Malpighi Bologna Italy
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ottavio Cavicchi, ENT Clinic Policlinico S.Orsola-Malpighi Bologna, Italy
ClinicalTrials.gov Identifier: NCT01163045     History of Changes
Other Study ID Numbers: 2 - Cavicchi
First Submitted: July 13, 2010
First Posted: July 15, 2010
Last Update Posted: July 15, 2010
Last Verified: June 2010

Keywords provided by University of Bologna:
neurostimulation
intraoperative neuromonitoring
recurrent laryngeal nerve
palsy of recurrent laryngeal nerve
RCT