Thyroid SurgeryNCT00661024
Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves in Thyroid Surgery
A study testing intraoperative RLN visualization and intraoperative neuromonitoring of the RLN in people with Thyroid Surgery, run by Jagiellonian University at 1 site in Poland.
Trial summary
Some recent studies have shown that intraoperative neuromonitoring (IONM) can aid the recurrent laryngeal nerve (RLN) identification during thyroid surgery. However, the role of IONM in reducing the incidence of RLN injury rate and the value of this method in predicting postoperative RLN function remain controversial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Surgery
- What is being tested?
- intraoperative RLN visualization and intraoperative neuromonitoring of the RLN
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2006to Apr 2008
- 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
- thyroid pathology qualified for first-time bilateral neck surgery
Who cannot join
- previous thyroid or parathyroid surgery,
- unilateral thyroid pathology eligible for minimally invasive approach (MIVAT),
- mediastinal goiter,
- preoperatively diagnosed RLN palsy,
- pregnancy or lactation,
- age below 18 years,
- high-risk patients ASA 4 grade (American Society of Anesthesiology),
- and inability to comply with the scheduled follow-up protocol.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Endocrine Surgery, Jagiellonian University College of Medicine
Krakow, 37 Pradnicka Street, 31-202
About this study
Official title: Randomized Clinical Trial Evaluating Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves in Thyroid Surgery
Some recent studies have shown that intraoperative neuromonitoring (IONM) can aid the recurrent laryngeal nerve (RLN) identification during thyroid surgery. However, the role of IONM in reducing the incidence of RLN injury rate and the value of this method in predicting postoperative RLN function remain controversial. Only a few published series represent level III of evidence and grade C of recommendation according to the evidence-based criteria (Sackett's classification, modified by Heinrich). Thus, the aim of this randomized clinical trial was to compare the impact of RLN visualization versus IONM on their morbidity following thyroid surgery.
Read the detailed description
Apart from hypoparathyroidism, dysfunction of the recurrent laryngeal nerve (RLN) is the most common complication following thyroid surgery. In consequence, the voice impairment leading to communication work-related problems and affecting psychological and social aspects of the individual's functioning diminishes the overall quality of life, being the common reason for medicolegal claims and litigation. The reported RLN palsy rate varies in the literature from 0% (for first-time thyroid surgery performed by an experienced endocrine surgeon) to as much as 20% (for reoperative thyroid surgery or thyroid malignancy surgery performed in low-volume centers), depending mostly on the type of thyroid disease (benign vs. malignant goiter), type (first-time vs. reoperation) and the extent of thyroid resection (subtotal vs. total thyroidectomy), surgical technique (with or without routine RLN identification) and the surgeon's experience (low-volume vs. high-volume thyroid surgery center.
In 1938, Lahey from Boston reported a significantly lower incidence of RLN injuries following thyroidectomy with dissection and visualization of the nerves as compared to operations without nerve identification. Since that time, many prospective studies have confirmed this observation, advocating routine RLN identification as the gold standard in safe thyroid surgery. But even in the most experienced hands RLN palsy occurs occasionally, with an average frequency below 1% of nerves at risk due to variability in RLNs anatomy and difficulties in nerve identification by visual or palpation control in challenging conditions (e.g. advanced thyroid malignancy or reoperative thyroid surgery). On the other hand, the use of intraoperative electrical stimulation for identifying the RLN nerve was described in 1966. However, the technique of intraoperative neuromonitoring (IONM) of RLN did not gain any widespread popularity until the late nineties of the last century, when several commercial user-friendly systems based on electromyographic signal recording became available. In these IONM systems, the RLN nerve stimulation is registered by elicited laryngeal muscles activity through the endoscopic insertion of the electrodes into the vocal cords, open insertion of the needle electrodes into the vocal muscles through the cricothyroid ligament or with the use of endotracheal tube surface electrodes. In addition to a plethora of signal acquisition techniques used in IONM, there is no consensus regarding the optimal method for nerve activity recording (continuous recording of spontaneous nerve activity versus repetitive stimulation) and no agreement as to which quantitative electromyographic parameter should be used as a predictor of postoperative vocal cord dysfunction (supramaximal versus minimal stimulation of the nerve at the end of the operation).
Some recent studies have shown that IONM can aid the RLN identification. However, the role of IONM in reducing the incidence of RLN injury rate and the value of this method in predicting postoperative RLN function remain controversial. Only a few published series represent level III of evidence and grade C of recommendation according to the evidence-based criteria (Sackett's classification, modified by Heinrich). Large, prospective, randomized trials addressing these issues and allowing for grade A recommendations are lacking due to some ethical concerns and large numbers of patients in each arm (more than 7000 patients) needed to reach the appropriate power of the study. To fulfill this gap in evidence, we designed a medium-size, single-center, prospective randomized study suitable for drawing more meaningful conclusions. Thus, the aim of this study was to compare the impact of RLN visualization versus IONM on their morbidity following thyroid surgery.
- Conditions
- Thyroid Surgery
- Being tested
- intraoperative RLN visualization, intraoperative neuromonitoring of the RLN
- Keywords
- thyroid surgery, recurrent laryngeal nerves visualization, intraoperative neuromonitoring, predictive values
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative RLN visualizationProcedure or surgery
Also called V-G
intraoperative RLN visualization
intraoperative neuromonitoring of the RLNProcedure or surgery
Also called IONM-G
IONM
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | RLN visualization alone Receives: Procedure: intraoperative RLN visualization |
| 2 | Experimental | IONM of the RLN Receives: Procedure: intraoperative neuromonitoring of the RLN |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of the recurrent laryngeal nerve injury
Measured: on 2nd postoperative day and than at 1, 2, 4, 6 and 12 months postoperatively, if paresis was noted on first examination
Secondary outcomes (2)
the IONM-added value to RLN identification
Measured: intraopreratively
the value of IONM in prediction of postoperative vocal cords function
Measured: intraoperative data compared with observation of vocal cords function postoperatively on the 2nd day postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startJan 2006
- Primary completionJun 2007
- Study completionApr 2008
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 SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Investigators
- Marcin Barczynski, MD, PhD, Principal investigator, Jagiellonian UniversityStanislaw Cichon, Prof, MD, Study chair, Jagiellonian UniversityAleksander Konturek, MD, PhD, Study director, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661024
- Sponsor's protocol ID
- BBN/501/ZKL/L
- Status last verified
- Apr 2008
- First submitted
- 15 Apr 2008
- Last updated
- 18 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dralle H, Sekulla C, Lorenz K, Brauckhoff M, Machens A; German IONM Study Group. Intraoperative monitoring of the recurrent laryngeal nerve in thyroid surgery. World J Surg. 2008 Jul;32(7):1358-66. doi: 10.1007/s00268-008-9483-2.
PubMed 18305996Snyder SK, Hendricks JC. Intraoperative neurophysiology testing of the recurrent laryngeal nerve: plaudits and pitfalls. Surgery. 2005 Dec;138(6):1183-91; discussion 1191-2. doi: 10.1016/j.surg.2005.08.027.
PubMed 16360407Tomoda C, Hirokawa Y, Uruno T, Takamura Y, Ito Y, Miya A, Kobayashi K, Matsuzuka F, Kuma K, Miyauchi A. Sensitivity and specificity of intraoperative recurrent laryngeal nerve stimulation test for predicting vocal cord palsy after thyroid surgery. World J Surg. 2006 Jul;30(7):1230-3. doi: 10.1007/s00268-005-0351-z.
PubMed 16773263Barczynski M, Konturek A, Cichon S. [Value of the intraoperative neuromonitoring in surgery for thyroid cancer in identification and prognosis of function of the recurrent laryngeal nerves]. Endokrynol Pol. 2006 Jul-Aug;57(4):343-6. Polish.
PubMed 17006834Thomusch O, Sekulla C, Machens A, Neumann HJ, Timmermann W, Dralle H. Validity of intra-operative neuromonitoring signals in thyroid surgery. Langenbecks Arch Surg. 2004 Nov;389(6):499-503. doi: 10.1007/s00423-003-0444-9. Epub 2004 Jan 13.
PubMed 14722777Barczynski 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 19177420
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Evaluating Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves in Thyroid Surgery
- ClinicalTrials.gov ID
- NCT00661024
- Acronym / sponsor ID
- BBN/501/ZKL/L
- Conditions
- Thyroid Surgery
- Keywords
- thyroid surgery, recurrent laryngeal nerves visualization, intraoperative neuromonitoring, predictive values
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 18 Apr 2008 (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.
Some recent studies have shown that intraoperative neuromonitoring (IONM) can aid the recurrent laryngeal nerve (RLN) identification during thyroid surgery. However, the role of IONM in reducing the incidence of RLN injury rate and the value of this method in predicting postoperative RLN function remain controversial. Only a few published series represent level III of evidence and grade C of recommendation according to the evidence-based criteria (Sackett's classification, modified by Heinrich). Thus, the aim of this randomized clinical trial was to compare the impact of RLN visualization versus IONM on their morbidity following thyroid surgery.
Detailed description
Apart from hypoparathyroidism, dysfunction of the recurrent laryngeal nerve (RLN) is the most common complication following thyroid surgery. In consequence, the voice impairment leading to communication work-related problems and affecting psychological and social aspects of the individual's functioning diminishes the overall quality of life, being the common reason for medicolegal claims and litigation. The reported RLN palsy rate varies in the literature from 0% (for first-time thyroid surgery performed by an experienced endocrine surgeon) to as much as 20% (for reoperative thyroid surgery or thyroid malignancy surgery performed in low-volume centers), depending mostly on the type of thyroid disease (benign vs. malignant goiter), type (first-time vs. reoperation) and the extent of thyroid resection (subtotal vs. total thyroidectomy), surgical technique (with or without routine RLN identification) and the surgeon's experience (low-volume vs. high-volume thyroid surgery center.
In 1938, Lahey from Boston reported a significantly lower incidence of RLN injuries following thyroidectomy with dissection and visualization of the nerves as compared to operations without nerve identification. Since that time, many prospective studies have confirmed this observation, advocating routine RLN identification as the gold standard in safe thyroid surgery. But even in the most experienced hands RLN palsy occurs occasionally, with an average frequency below 1% of nerves at risk due to variability in RLNs anatomy and difficulties in nerve identification by visual or palpation control in challenging conditions (e.g. advanced thyroid malignancy or reoperative thyroid surgery). On the other hand, the use of intraoperative electrical stimulation for identifying the RLN nerve was described in 1966. However, the technique of intraoperative neuromonitoring (IONM) of RLN did not gain any widespread popularity until the late nineties of the last century, when several commercial user-friendly systems based on electromyographic signal recording became available. In these IONM systems, the RLN nerve stimulation is registered by elicited laryngeal muscles activity through the endoscopic insertion of the electrodes into the vocal cords, open insertion of the needle electrodes into the vocal muscles through the cricothyroid ligament or with the use of endotracheal tube surface electrodes. In addition to a plethora of signal acquisition techniques used in IONM, there is no consensus regarding the optimal method for nerve activity recording (continuous recording of spontaneous nerve activity versus repetitive stimulation) and no agreement as to which quantitative electromyographic parameter should be used as a predictor of postoperative vocal cord dysfunction (supramaximal versus minimal stimulation of the nerve at the end of the operation).
Some recent studies have shown that IONM can aid the RLN identification. However, the role of IONM in reducing the incidence of RLN injury rate and the value of this method in predicting postoperative RLN function remain controversial. Only a few published series represent level III of evidence and grade C of recommendation according to the evidence-based criteria (Sackett's classification, modified by Heinrich). Large, prospective, randomized trials addressing these issues and allowing for grade A recommendations are lacking due to some ethical concerns and large numbers of patients in each arm (more than 7000 patients) needed to reach the appropriate power of the study. To fulfill this gap in evidence, we designed a medium-size, single-center, prospective randomized study suitable for drawing more meaningful conclusions. Thus, the aim of this study was to compare the impact of RLN visualization versus IONM on their morbidity following thyroid surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Procedure: intraoperative RLN visualizationRLN visualization alone |
| 2 | Experimental | Procedure: intraoperative neuromonitoring of the RLNIONM of the RLN |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- thyroid pathology qualified for first-time bilateral neck surgery
Key exclusion criteria (8 listed)
- previous thyroid or parathyroid surgery,
- unilateral thyroid pathology eligible for minimally invasive approach (MIVAT),
- mediastinal goiter,
- preoperatively diagnosed RLN palsy,
- pregnancy or lactation,
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 RLN visualizationAlso: V-Gintraoperative RLN visualization | Procedure or surgery | 1 |
| intraoperative neuromonitoring of the RLNAlso: IONM-GIONM | Procedure or surgery | 2 |
Primary outcome
the incidence of the recurrent laryngeal nerve injury
Time frame: on 2nd postoperative day and than at 1, 2, 4, 6 and 12 months postoperatively, if paresis was noted on first examination
2 secondary outcomes
the IONM-added value to RLN identification
Time frame: intraopreratively
the value of IONM in prediction of postoperative vocal cords function
Time frame: intraoperative data compared with observation of vocal cords function postoperatively on the 2nd day postop
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 18 Apr 2008.
- Background: PubMed 18305996Dralle H, Sekulla C, Lorenz K, Brauckhoff M, Machens A; German IONM Study Group. Intraoperative monitoring of the recurrent laryngeal nerve in thyroid surgery. World J Surg. 2008 Jul;32(7):1358-66. doi: 10.1007/s00268-008-9483-2.
- Background: PubMed 16360407Snyder SK, Hendricks JC. Intraoperative neurophysiology testing of the recurrent laryngeal nerve: plaudits and pitfalls. Surgery. 2005 Dec;138(6):1183-91; discussion 1191-2. doi: 10.1016/j.surg.2005.08.027.
- Background: PubMed 16773263Tomoda C, Hirokawa Y, Uruno T, Takamura Y, Ito Y, Miya A, Kobayashi K, Matsuzuka F, Kuma K, Miyauchi A. Sensitivity and specificity of intraoperative recurrent laryngeal nerve stimulation test for predicting vocal cord palsy after thyroid surgery. World J Surg. 2006 Jul;30(7):1230-3. doi: 10.1007/s00268-005-0351-z.
- Background: PubMed 17006834Barczynski M, Konturek A, Cichon S. [Value of the intraoperative neuromonitoring in surgery for thyroid cancer in identification and prognosis of function of the recurrent laryngeal nerves]. Endokrynol Pol. 2006 Jul-Aug;57(4):343-6. Polish.
- Background: PubMed 14722777Thomusch O, Sekulla C, Machens A, Neumann HJ, Timmermann W, Dralle H. Validity of intra-operative neuromonitoring signals in thyroid surgery. Langenbecks Arch Surg. 2004 Nov;389(6):499-503. doi: 10.1007/s00423-003-0444-9. Epub 2004 Jan 13.
- Derived from this study: 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.
Related trials for Thyroid Surgery
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingPhase 2
Zanzalintinib for the Treatment of Advanced Thyroid Cancer Before Surgery
Neoadjuvant Treatment, Thyroid Cancer
Recruiting
Comparison of Post-operative Outcomes Between ERAS Protocol and Non-ERAS Local Regimen in Patients Undergoing Thyroidectomy
Thyroid Diseases, Ambulation Time
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
Enrolling by invitation
Effect of Cold Water Spray on Swallowing Difficulty, Pain, and Thirst After Thyroid Surgery
Swallowing Difficulties, Thirst
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
Stanislaw Cichon, Prof, MD study chair
Jagiellonian University
Aleksander Konturek, MD, PhD study director
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoperative RLN visualization and intraoperative neuromonitoring of the RLN in people with Thyroid Surgery, 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 8 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 18 Apr 2008. 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. Some participants in this study may receive a placebo. 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 incidence of the recurrent laryngeal nerve injury (time frame: on 2nd postoperative day and than at 1, 2, 4, 6 and 12 months postoperatively, if paresis was noted on first examination). 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 NCT00661024, 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 18 Apr 2008.