- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01163045
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
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
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Italy/Bologna
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Bologna, Italy/Bologna, Italy, 40100
- Policlinico S.Orsola-Malpighi ENT Clini University of Bologna Italy
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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.
Sponsor
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.
General Publications
- 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.
- 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.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2 - Cavicchi
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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