ThyroidectomyPhase 2NCT01163045
Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation
A Phase 2 study testing thyroidectomy in people with Thyroidectomy, run by University of Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroidectomy
- What is being tested?
- thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mono or bilateral thyroid surgery
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Policlinico S.Orsola-Malpighi ENT Clini University of Bologna Italy
Bologna, Italy/Bologna, 40100
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroidectomy
- Being tested
- thyroidectomy
- Keywords
- neurostimulation, intraoperative neuromonitoring, recurrent laryngeal nerve, palsy of recurrent laryngeal nerve, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroidectomyProcedure or surgery
total thyroidectomy and lobectomy
| Study group | Role | What they receive |
|---|---|---|
| neuromonitoring and neurostimulation | Experimental | Not described Receives: Procedure: thyroidectomy |
| neurostimulation of recurrent laryngeal nerve | Experimental | Not described Receives: Procedure: thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent laryngeal nerve paralysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startJan 2008
- Primary completionFeb 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Investigators
- Ottavio O Cavicchi, MD, Study director, ENT Clinic Ploiclinico S.Orsola-Malpighi Bologna Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163045
- Sponsor's protocol ID
- 2 - Cavicchi
- Status last verified
- Jun 2010
- First submitted
- 13 Jul 2010
- Last updated
- 15 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 19177420Cavicchi 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.
PubMed 21469244
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Neuromonitoring and Neurostimulation of the Recurrent Laryngeal Nerve Versus Neurostimulation Alone in Thyroid Surgery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01163045
- Acronym / sponsor ID
- 2 - Cavicchi
- Conditions
- Thyroidectomy
- Keywords
- neurostimulation, intraoperative neuromonitoring, recurrent laryngeal nerve, palsy of recurrent laryngeal nerve, RCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neuromonitoring and neurostimulation | Experimental | Procedure: thyroidectomy |
| neurostimulation of recurrent laryngeal nerve | Experimental | Procedure: thyroidectomy |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mono or bilateral thyroid surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thyroidectomytotal thyroidectomy and lobectomy | Procedure or surgery | neuromonitoring and neurostimulation, neurostimulation of recurrent laryngeal nerve |
Primary outcome
recurrent laryngeal nerve paralysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2010.
- Results publication: PubMed 19177420Barczynski 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.
- Derived from this study: PubMed 21469244Cavicchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ottavio O Cavicchi, MD study director
ENT Clinic Ploiclinico S.Orsola-Malpighi Bologna Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing thyroidectomy in people with Thyroidectomy, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrent laryngeal nerve paralysis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01163045, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2010.