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Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation

Primary Purpose

Thyroidectomy

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
thyroidectomy
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroidectomy focused on measuring neurostimulation, intraoperative neuromonitoring, recurrent laryngeal nerve, palsy of recurrent laryngeal nerve, RCT

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

neuromonitoring and neurostimulation

neurostimulation of recurrent laryngeal nerve

Arm Description

Outcomes

Primary Outcome Measures

recurrent laryngeal nerve paralysis

Secondary Outcome Measures

Full Information

First Posted
July 13, 2010
Last Updated
July 14, 2010
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT01163045
Brief Title
Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation
Official Title
Intraoperative Neuromonitoring and Neurostimulation of the Recurrent Laryngeal Nerve Versus Neurostimulation Alone in Thyroid Surgery: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Bologna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroidectomy
Keywords
neurostimulation, intraoperative neuromonitoring, recurrent laryngeal nerve, palsy of recurrent laryngeal nerve, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
neuromonitoring and neurostimulation
Arm Type
Experimental
Arm Title
neurostimulation of recurrent laryngeal nerve
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
thyroidectomy
Intervention Description
total thyroidectomy and lobectomy
Primary Outcome Measure Information:
Title
recurrent laryngeal nerve paralysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ottavio O Cavicchi, MD
Organizational Affiliation
ENT Clinic Ploiclinico S.Orsola-Malpighi Bologna Italy
Official's Role
Study Director
Facility Information:
Facility Name
Policlinico S.Orsola-Malpighi ENT Clini University of Bologna Italy
City
Bologna
State/Province
Italy/Bologna
ZIP/Postal Code
40100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19177420
Citation
Barczynski M, Konturek A, Cichon S. Randomized clinical trial of visualization versus neuromonitoring of recurrent laryngeal nerves during thyroidectomy. Br J Surg. 2009 Mar;96(3):240-6. doi: 10.1002/bjs.6417.
Results Reference
result
PubMed Identifier
21469244
Citation
Cavicchi O, Caliceti U, Fernandez IJ, Ceroni AR, Marcantoni A, Sciascia S, Sottili S, Piccin O. Laryngeal neuromonitoring and neurostimulation versus neurostimulation alone in thyroid surgery: a randomized clinical trial. Head Neck. 2012 Feb;34(2):141-5. doi: 10.1002/hed.21681. Epub 2011 Apr 5.
Results Reference
derived

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Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation

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