Thyroid,NCT01395134
Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.
A study testing Neuromonitoring in people with Thyroid, and Goiter,, run by Jagiellonian University at 1 site in Poland.
Trial summary
Injury to the external branch of the superior laryngeal nerve (EBSLN) during thyroidectomy results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Neuromonitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2009to Dec 2010
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- thyroid pathology qualified for first-time bilateral neck surgery in a female patient with small to moderate sized goiter (below 100 ml in volume).
Who cannot join
- male gender,
- previous neck surgery,
- unilateral thyroid pathology eligible for unilateral lobectomy,
- goiter volume above 100 ml,
- preoperatively diagnosed RLN palsy,
- abnormal preoperative voice assessment on GRBAS scale,
Show all 10Show fewer
- pregnancy or lactation,
- age below 18 years,
- high-risk patients ASA 4 grade (American Society of Anesthesiology),
- inability to comply with the scheduled follow-up protocol.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery
Krakow, 31-202
About this study
Official title: Randomized Controlled Trial of Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.
Injury to the external branch of the superior laryngeal nerve (EBSLN) during thyroidectomy results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. It remains unclear if use of intraoperative nerve monitoring (IONM) can improve clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.
Read the detailed description
Phonation changes following thyroidectomy have been reported in many investigations. They are considered to be multifactorial in origin and can be a consequence of laryngeal nerve injury or other events during thyroidectomy including arytenoids trauma after endotracheal intubation, cricothyroid dysfunction, strap muscle malfunction or lesion of the perithyroidal neural plexus, laryngotracheal fixation with impairment of vertical movement and psychological reaction to the operation. Injury to the external branch of the superior laryngeal nerve (EBSLN) can occur during the dissection and clamping of the superior thyroid vessels and the prevalence of this complication has been reported from 0.5% to 58%. This injury causes a complete paralysis of the cricothyroid muscle which results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. Intraoperative nerve monitoring (IONM) has gained widespread acceptance as an adjunct to the gold standard of visual nerve identification and this technique can be used to identify both the recurrent laryngeal nerve (RLN) and the EBSLN. However, it remains unclear if there is any IONM added-value to the clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.
- Being tested
- Neuromonitoring
- Keywords
- External branch of the superior laryngeal nerve,, Recurrent laryngeal nerve,, Intraoperative neuromonitoring,, Thyroid surgery
- Medical subject headings
- Thyroid Diseases, Goiter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuromonitoringDevice
Also called IONM
Electrical stimulation of the nerve: 1 mA, 4 Hz with surface electromyography of the vocalis muscles.
| Study group | Role | What they receive |
|---|---|---|
| Visualization of the EBSLN and RLN | No intervention | Visual inspection of the nerves. |
| Neuromonitoring of the EBSLN and RLN | Experimental | Electrical stimulation and monitoring of the nerves' function. Receives: Device: Neuromonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The identification rate of the external branch of the superior laryngeal nerve.
Measured: up to 6 months postoperatively
Secondary outcomes (2)
Anatomical variability of the external branch of the superior laryngeal nerve according to Cernea classification.
Measured: up to 6 months postoperatively
The changes in postoperative voice performance.
The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.
Measured: up to 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Thyroid,Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Investigators
- Marcin Barczynski, MD, PhD, Principal investigator, Jagiellonian University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395134
- Sponsor's protocol ID
- BBN/501/ZKL/1446
- Status last verified
- Jul 2011
- First submitted
- 13 Jul 2011
- Last updated
- 15 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cernea CR, Ferraz AR, Furlani J, Monteiro S, Nishio S, Hojaij FC, Dutra Junior A, Marques LA, Pontes PA, Bevilacqua RG. Identification of the external branch of the superior laryngeal nerve during thyroidectomy. Am J Surg. 1992 Dec;164(6):634-9. doi: 10.1016/s0002-9610(05)80723-8.
PubMed 1463114Cernea CR, Ferraz AR, Nishio S, Dutra A Jr, Hojaij FC, dos Santos LR. Surgical anatomy of the external branch of the superior laryngeal nerve. Head Neck. 1992 Sep-Oct;14(5):380-3. doi: 10.1002/hed.2880140507.
PubMed 1399571Randolph GW, Dralle H; International Intraoperative Monitoring Study Group; Abdullah H, Barczynski M, Bellantone R, Brauckhoff M, Carnaille B, Cherenko S, Chiang FY, Dionigi G, Finck C, Hartl D, Kamani D, Lorenz K, Miccolli P, Mihai R, Miyauchi A, Orloff L, Perrier N, Poveda MD, Romanchishen A, Serpell J, Sitges-Serra A, Sloan T, Van Slycke S, Snyder S, Takami H, Volpi E, Woodson G. Electrophysiologic recurrent laryngeal nerve monitoring during thyroid and parathyroid surgery: international standards guideline statement. Laryngoscope. 2011 Jan;121 Suppl 1:S1-16. doi: 10.1002/lary.21119.
PubMed 21181860Lifante JC, McGill J, Murry T, Aviv JE, Inabnet WB 3rd. A prospective, randomized trial of nerve monitoring of the external branch of the superior laryngeal nerve during thyroidectomy under local/regional anesthesia and IV sedation. Surgery. 2009 Dec;146(6):1167-73. doi: 10.1016/j.surg.2009.09.023.
PubMed 19958945Bellantone R, Boscherini M, Lombardi CP, Bossola M, Rubino F, De Crea C, Alesina P, Traini E, Cozza T, D'alatri L. Is the identification of the external branch of the superior laryngeal nerve mandatory in thyroid operation? Results of a prospective randomized study. Surgery. 2001 Dec;130(6):1055-9. doi: 10.1067/msy.2001.118375.
PubMed 11742338Barczynski M, Konturek A, Stopa M, Honowska A, Nowak W. Randomized controlled trial of visualization versus neuromonitoring of the external branch of the superior laryngeal nerve during thyroidectomy. World J Surg. 2012 Jun;36(6):1340-7. doi: 10.1007/s00268-012-1547-7.
PubMed 22402975
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.
- ClinicalTrials.gov ID
- NCT01395134
- Acronym / sponsor ID
- BBN/501/ZKL/1446
- Keywords
- External branch of the superior laryngeal nerve,, Recurrent laryngeal nerve,, Intraoperative neuromonitoring,, Thyroid surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Jul 2011 (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.
Injury to the external branch of the superior laryngeal nerve (EBSLN) during thyroidectomy results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. It remains unclear if use of intraoperative nerve monitoring (IONM) can improve clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.
Detailed description
Phonation changes following thyroidectomy have been reported in many investigations. They are considered to be multifactorial in origin and can be a consequence of laryngeal nerve injury or other events during thyroidectomy including arytenoids trauma after endotracheal intubation, cricothyroid dysfunction, strap muscle malfunction or lesion of the perithyroidal neural plexus, laryngotracheal fixation with impairment of vertical movement and psychological reaction to the operation. Injury to the external branch of the superior laryngeal nerve (EBSLN) can occur during the dissection and clamping of the superior thyroid vessels and the prevalence of this complication has been reported from 0.5% to 58%. This injury causes a complete paralysis of the cricothyroid muscle which results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. Intraoperative nerve monitoring (IONM) has gained widespread acceptance as an adjunct to the gold standard of visual nerve identification and this technique can be used to identify both the recurrent laryngeal nerve (RLN) and the EBSLN. However, it remains unclear if there is any IONM added-value to the clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visualization of the EBSLN and RLN | No intervention | –Visual inspection of the nerves. |
| Neuromonitoring of the EBSLN and RLN | Experimental | Device: NeuromonitoringElectrical stimulation and monitoring of the nerves' function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- thyroid pathology qualified for first-time bilateral neck surgery in a female patient with small to moderate sized goiter (below 100 ml in volume).
Key exclusion criteria (10 listed)
- male gender,
- previous neck surgery,
- unilateral thyroid pathology eligible for unilateral lobectomy,
- goiter volume above 100 ml,
- preoperatively diagnosed RLN palsy,
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 |
|---|---|---|
| NeuromonitoringAlso: IONMElectrical stimulation of the nerve: 1 mA, 4 Hz with surface electromyography of the vocalis muscles. | Device | Neuromonitoring of the EBSLN and RLN |
Primary outcome
The identification rate of the external branch of the superior laryngeal nerve.
Time frame: up to 6 months postoperatively
2 secondary outcomes
Anatomical variability of the external branch of the superior laryngeal nerve according to Cernea classification.
Time frame: up to 6 months postoperatively
The changes in postoperative voice performance.
Time frame: up to 6 months postoperatively
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 2011.
- Background: PubMed 1463114Cernea CR, Ferraz AR, Furlani J, Monteiro S, Nishio S, Hojaij FC, Dutra Junior A, Marques LA, Pontes PA, Bevilacqua RG. Identification of the external branch of the superior laryngeal nerve during thyroidectomy. Am J Surg. 1992 Dec;164(6):634-9. doi: 10.1016/s0002-9610(05)80723-8.
- Background: PubMed 1399571Cernea CR, Ferraz AR, Nishio S, Dutra A Jr, Hojaij FC, dos Santos LR. Surgical anatomy of the external branch of the superior laryngeal nerve. Head Neck. 1992 Sep-Oct;14(5):380-3. doi: 10.1002/hed.2880140507.
- Background: PubMed 21181860Randolph GW, Dralle H; International Intraoperative Monitoring Study Group; Abdullah H, Barczynski M, Bellantone R, Brauckhoff M, Carnaille B, Cherenko S, Chiang FY, Dionigi G, Finck C, Hartl D, Kamani D, Lorenz K, Miccolli P, Mihai R, Miyauchi A, Orloff L, Perrier N, Poveda MD, Romanchishen A, Serpell J, Sitges-Serra A, Sloan T, Van Slycke S, Snyder S, Takami H, Volpi E, Woodson G. Electrophysiologic recurrent laryngeal nerve monitoring during thyroid and parathyroid surgery: international standards guideline statement. Laryngoscope. 2011 Jan;121 Suppl 1:S1-16. doi: 10.1002/lary.21119.
- Background: PubMed 19958945Lifante JC, McGill J, Murry T, Aviv JE, Inabnet WB 3rd. A prospective, randomized trial of nerve monitoring of the external branch of the superior laryngeal nerve during thyroidectomy under local/regional anesthesia and IV sedation. Surgery. 2009 Dec;146(6):1167-73. doi: 10.1016/j.surg.2009.09.023.
- Background: PubMed 11742338Bellantone R, Boscherini M, Lombardi CP, Bossola M, Rubino F, De Crea C, Alesina P, Traini E, Cozza T, D'alatri L. Is the identification of the external branch of the superior laryngeal nerve mandatory in thyroid operation? Results of a prospective randomized study. Surgery. 2001 Dec;130(6):1055-9. doi: 10.1067/msy.2001.118375.
- Derived from this study: PubMed 22402975Barczynski M, Konturek A, Stopa M, Honowska A, Nowak W. Randomized controlled trial of visualization versus neuromonitoring of the external branch of the superior laryngeal nerve during thyroidectomy. World J Surg. 2012 Jun;36(6):1340-7. doi: 10.1007/s00268-012-1547-7.
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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.
Marcin Barczynski, MD, PhD principal investigator
Jagiellonian University, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromonitoring in people with Thyroid, and Goiter,, run by Jagiellonian University at 1 site in Poland.
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 10 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 2011. 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 Poland. 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.
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?
The identification rate of the external branch of the superior laryngeal nerve. (time frame: up to 6 months postoperatively). 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 NCT01395134, which also lists 6 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 2011.