Recurrent Laryngeal Nerve InjuriesNCT02493881
Recurrent Laryngeal Nerve's Motor Function: Sometimes Motor Fibers May Also Be Located in The Posterior Branch
A study testing intraoperative neuromonitoring in people with Recurrent Laryngeal Nerve Injuries, run by Sisli Hamidiye Etfal Training and Research Hospital.
Trial summary
The investigators hypothesized that, sometimes the posterior branch of the recurrent laryngeal nerve may also have motor function. The investigators aimed to evaluate motor function of the branches in the branching recurrent laryngeal nerves in this study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Recurrent Laryngeal Nerve Injuries
- What is being tested?
- intraoperative neuromonitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Mar 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent parathyroid/thyroid surgery with intraoperative neuromonitoring ,
- Patients who had normal vocal cord functions preoperatively. -
Who cannot join
- Preoperative recurrent laryngeal nerve palsy,
- Intentional nerve transection because of cancer invasion,
- Assessment failure of recurrent laryngeal nerve function due to the deficiency of the intraoperative neuromonitoring equipment,.
- Parathyroidectomy operations that recurrent laryngeal nerves were not fully dissected.
- -
About this study
Official title: Descriptive in Vivo Study of Evaluating the Motor Function of Recurrent Laryngeal Nerve's Extralaryngeal Branching Electromyographically.
The investigators hypothesized that, sometimes the posterior branch of the recurrent laryngeal nerve may also have motor function. The investigators aimed to evaluate motor function of the branches in the branching recurrent laryngeal nerves in this study.
Read the detailed description
This study group consisted of consecutive patients, undergoing thyroid and parathyroid surgery with IONM. Both anterior and posterior branches of the recurrent laryngeal nerves were assessed separately by both electromyography endotracheal tube for adduction and finger palpation for detection of laryngeal twitch due to posterior cricoarytenoid abduction. The recurrent laryngeal nerves having motor function only in the anterior branches were defined as group 1, whereas the nerves having motor function both in the anterior and posterior branches were as group 2.
- Conditions
- Recurrent Laryngeal Nerve Injuries
- Being tested
- intraoperative neuromonitoring
- Keywords
- Motor function of the extralaryngeal branches, intraoperative neuromonitoring, recurrent laryngeal nerve
- Medical subject headings
- Recurrent Laryngeal Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative neuromonitoringDevice
NIM-Response 3.0 Intraoperative Neuromonitoring System (Medtronic Xomed, Jacksonville, FL, USA) was used to record the EMG amplitude signal for the anterior and/or posterior branches of recurrent laryngeal nerves (RLNs).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | The RLNs having motor function on the anterior branch assessed by intraoperative neuromonitoring. Receives: Device: intraoperative neuromonitoring |
| Group 2 | Active comparator | RLNs having motor function on anterior and posterior branch assessed by intraoperative neuromonitoring. Receives: Device: intraoperative neuromonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evoked EMG potentials of the branches of the recurrent laryngeal nerves as microvolt, by intraoperative neuromonitoring.
The nerves , due to having motor functions whether on their anterior or posterior branches, were divided into two groups. The amplitudes of the anterior and posterior branches within the group 2 were compared.
Measured: intraoperative
Secondary outcomes (2)
The diameters of the branches of the recurrent laryngeal nerves.
The branch diameters of the recurrent laryngeal nerves were compared between the two groups.
Measured: intraoperative
The branching distances of the recurrent laryngeal nerves.
The branching distances of the recurrent laryngeal nerves till the entry point into the larynx, were compared between the two groups.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJan 2012
- Primary completionSep 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Recurrent Laryngeal Nerve InjuriesStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Uludag, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Adnan Isgor, Prof., Study director, Bahcesehir University Medical Faculty, Department of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493881
- Sponsor's protocol ID
- SEEAH01
- Status last verified
- Jul 2015
- First submitted
- 26 Jun 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gurleyik E. Location of motor fibers within branches of the recurrent laryngeal nerve with extralaryngeal terminal bifurcation; Functional identification by intraoperative neuromonitoring. Surgery. 2015 Nov;158(5):1339-44. doi: 10.1016/j.surg.2015.04.019. Epub 2015 Jun 6.
PubMed 26054316Fontenot TE, Randolph GW, Friedlander PL, Masoodi H, Yola IM, Kandil E. Gender, race, and electrophysiologic characteristics of the branched recurrent laryngeal nerve. Laryngoscope. 2014 Oct;124(10):2433-7. doi: 10.1002/lary.24631. Epub 2014 Mar 25.
PubMed 24493270Serpell JW, Yeung MJ, Grodski S. The motor fibers of the recurrent laryngeal nerve are located in the anterior extralaryngeal branch. Ann Surg. 2009 Apr;249(4):648-52. doi: 10.1097/SLA.0b013e31819ed9a4.
PubMed 19300223Chiang FY, Lu IC, Chen HC, Chen HY, Tsai CJ, Hsiao PJ, Lee KW, Wu CW. Anatomical variations of recurrent laryngeal nerve during thyroid surgery: how to identify and handle the variations with intraoperative neuromonitoring. Kaohsiung J Med Sci. 2010 Nov;26(11):575-83. doi: 10.1016/S1607-551X(10)70089-9.
PubMed 21126710Cernea CR, Hojaij FC, De Carlucci D Jr, Gotoda R, Plopper C, Vanderlei F, Brandao LG. Recurrent laryngeal nerve: a plexus rather than a nerve? Arch Otolaryngol Head Neck Surg. 2009 Nov;135(11):1098-102. doi: 10.1001/archoto.2009.151.
PubMed 19917921Casella C, Pata G, Nascimbeni R, Mittempergher F, Salerni B. Does extralaryngeal branching have an impact on the rate of postoperative transient or permanent recurrent laryngeal nerve palsy? World J Surg. 2009 Feb;33(2):261-5. doi: 10.1007/s00268-008-9832-1.
PubMed 19023612Kandil E, Abdel Khalek M, Aslam R, Friedlander P, Bellows CF, Slakey D. Recurrent laryngeal nerve: significance of the anterior extralaryngeal branch. Surgery. 2011 Jun;149(6):820-4. doi: 10.1016/j.surg.2011.02.012. Epub 2011 Apr 17.
PubMed 21497872Kandil E, Abdelghani S, Friedlander P, Alrasheedi S, Tufano RP, Bellows CF, Slakey D. Motor and sensory branching of the recurrent laryngeal nerve in thyroid surgery. Surgery. 2011 Dec;150(6):1222-7. doi: 10.1016/j.surg.2011.09.002.
PubMed 22136844
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive in Vivo Study of Evaluating the Motor Function of Recurrent Laryngeal Nerve's Extralaryngeal Branching Electromyographically.
- ClinicalTrials.gov ID
- NCT02493881
- Acronym / sponsor ID
- SEEAH01
- Conditions
- Recurrent Laryngeal Nerve Injuries
- Keywords
- Motor function of the extralaryngeal branches, intraoperative neuromonitoring, recurrent laryngeal nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Jul 2015 (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 investigators hypothesized that, sometimes the posterior branch of the recurrent laryngeal nerve may also have motor function. The investigators aimed to evaluate motor function of the branches in the branching recurrent laryngeal nerves in this study.
Detailed description
This study group consisted of consecutive patients, undergoing thyroid and parathyroid surgery with IONM. Both anterior and posterior branches of the recurrent laryngeal nerves were assessed separately by both electromyography endotracheal tube for adduction and finger palpation for detection of laryngeal twitch due to posterior cricoarytenoid abduction. The recurrent laryngeal nerves having motor function only in the anterior branches were defined as group 1, whereas the nerves having motor function both in the anterior and posterior branches were as group 2.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: intraoperative neuromonitoringThe RLNs having motor function on the anterior branch assessed by intraoperative neuromonitoring. |
| Group 2 | Active comparator | Device: intraoperative neuromonitoringRLNs having motor function on anterior and posterior branch assessed by intraoperative neuromonitoring. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who underwent parathyroid/thyroid surgery with intraoperative neuromonitoring ,
- Patients who had normal vocal cord functions preoperatively. -
Key exclusion criteria (5 listed)
- Preoperative recurrent laryngeal nerve palsy,
- Intentional nerve transection because of cancer invasion,
- Assessment failure of recurrent laryngeal nerve function due to the deficiency of the intraoperative neuromonitoring equipment,.
- Parathyroidectomy operations that recurrent laryngeal nerves were not fully dissected.
- -
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 |
|---|---|---|
| intraoperative neuromonitoringNIM-Response 3.0 Intraoperative Neuromonitoring System (Medtronic Xomed, Jacksonville, FL, USA) was used to record the EMG amplitude signal for the anterior and/or posterior branches of recurrent laryngeal nerves (RLNs). | Device | Group 1, Group 2 |
Primary outcome
The evoked EMG potentials of the branches of the recurrent laryngeal nerves as microvolt, by intraoperative neuromonitoring.
Time frame: intraoperative
The nerves , due to having motor functions whether on their anterior or posterior branches, were divided into two groups. The amplitudes of the anterior and posterior branches within the group 2 were compared.
2 secondary outcomes
The diameters of the branches of the recurrent laryngeal nerves.
Time frame: intraoperative
The branching distances of the recurrent laryngeal nerves.
Time frame: intraoperative
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 10 Jul 2015.
- Results publication: PubMed 26054316Gurleyik E. Location of motor fibers within branches of the recurrent laryngeal nerve with extralaryngeal terminal bifurcation; Functional identification by intraoperative neuromonitoring. Surgery. 2015 Nov;158(5):1339-44. doi: 10.1016/j.surg.2015.04.019. Epub 2015 Jun 6.
- Results publication: PubMed 24493270Fontenot TE, Randolph GW, Friedlander PL, Masoodi H, Yola IM, Kandil E. Gender, race, and electrophysiologic characteristics of the branched recurrent laryngeal nerve. Laryngoscope. 2014 Oct;124(10):2433-7. doi: 10.1002/lary.24631. Epub 2014 Mar 25.
- Results publication: PubMed 19300223Serpell JW, Yeung MJ, Grodski S. The motor fibers of the recurrent laryngeal nerve are located in the anterior extralaryngeal branch. Ann Surg. 2009 Apr;249(4):648-52. doi: 10.1097/SLA.0b013e31819ed9a4.
- Results publication: PubMed 21126710Chiang FY, Lu IC, Chen HC, Chen HY, Tsai CJ, Hsiao PJ, Lee KW, Wu CW. Anatomical variations of recurrent laryngeal nerve during thyroid surgery: how to identify and handle the variations with intraoperative neuromonitoring. Kaohsiung J Med Sci. 2010 Nov;26(11):575-83. doi: 10.1016/S1607-551X(10)70089-9.
- Results publication: PubMed 19917921Cernea CR, Hojaij FC, De Carlucci D Jr, Gotoda R, Plopper C, Vanderlei F, Brandao LG. Recurrent laryngeal nerve: a plexus rather than a nerve? Arch Otolaryngol Head Neck Surg. 2009 Nov;135(11):1098-102. doi: 10.1001/archoto.2009.151.
- Results publication: PubMed 19023612Casella C, Pata G, Nascimbeni R, Mittempergher F, Salerni B. Does extralaryngeal branching have an impact on the rate of postoperative transient or permanent recurrent laryngeal nerve palsy? World J Surg. 2009 Feb;33(2):261-5. doi: 10.1007/s00268-008-9832-1.
- Results publication: PubMed 21497872Kandil E, Abdel Khalek M, Aslam R, Friedlander P, Bellows CF, Slakey D. Recurrent laryngeal nerve: significance of the anterior extralaryngeal branch. Surgery. 2011 Jun;149(6):820-4. doi: 10.1016/j.surg.2011.02.012. Epub 2011 Apr 17.
- Results publication: PubMed 22136844Kandil E, Abdelghani S, Friedlander P, Alrasheedi S, Tufano RP, Bellows CF, Slakey D. Motor and sensory branching of the recurrent laryngeal nerve in thyroid surgery. Surgery. 2011 Dec;150(6):1222-7. doi: 10.1016/j.surg.2011.09.002.
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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.
Adnan Isgor, Prof. study director
Bahcesehir University Medical Faculty, Department of General Surgery
Questions about this trial
What is this clinical trial studying?
A study testing intraoperative neuromonitoring in people with Recurrent Laryngeal Nerve Injuries, run by Sisli Hamidiye Etfal Training and Research Hospital.
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 2 inclusion and 5 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 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 evoked EMG potentials of the branches of the recurrent laryngeal nerves as microvolt, by intraoperative neuromonitoring. (time frame: intraoperative). 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 NCT02493881, which also lists 8 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 10 Jul 2015.