Thyroid CancerNCT06254859
Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery
An observational study of Thyroid Cancer and Thyroid Cancer, Papillary, run by Fujian Medical University at 1 site in China.
Trial summary
This study examines the impact of intraoperative recurrent laryngeal nerve monitoring signal changes on the postoperative voice quality of thyroid surgery patients. By analyzing extensive surgical data and postoperative voice recordings, the investigation seeks to identify patterns in the variations of these signals… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer, Thyroid Cancer, Papillary
- What is being tested?
- Traditional thyroid surgery.
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with thyroid cancer who are planned to undergo traditional surgical treatment.
Who may be able to join
- Age 20-60 years old.
- Planned conventional unilateral thyroid lobectomy + isthmus resection + central compartment lymph node dissection.
Who cannot join
- History of past head and neck surgeries.
- Pronunciation system defect and disorder history.
- History of vocal cord polyps or nodules.
- History of upper respiratory tract infection in the 2 weeks before surgery or postoperative infection history.
- History of neurological disorders.
- Abnormalities in the throat.
Show all 11Show fewer
- Preoperative damage to throat morphology or motor function.
- Preoperative functional voice or language disorders, noticeable hoarseness, or difficulty in pronunciation.
- Pre- and postoperative laryngoscopic examination showing vocal cord paralysis and arytenoid joint dislocation.
- Neurological disorders causing abnormal throat function.
- Patient unable to cooperate with VHI (Voice Handicap Index) assessment and voice spectrum examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Bo Wang Porfessor, MD, +13959123550, wangbo@fjmu.edu.cn
Bo Wang, MD
About this study
This study examines the impact of intraoperative recurrent laryngeal nerve monitoring signal changes on the postoperative voice quality of thyroid surgery patients. By analyzing extensive surgical data and postoperative voice recordings, the investigation seeks to identify patterns in the variations of these signals and their correlation with voice quality outcomes. The goal is to enhance clinical understanding and surgical practices, allowing for more precise assessments of nerve function, informed surgical interventions, and improved postoperative patient well-being.
Read the detailed description
This research project conducts a detailed exploration into the fluctuations of intraoperative recurrent laryngeal nerve monitoring signals during thyroid surgery and their subsequent effects on the voice quality of patients after surgery. The study meticulously analyzes a comprehensive dataset comprised of surgical records and voice analyses conducted before and after the procedure. The primary objective is to pinpoint specific trends and changes in the nerve monitoring signals and to determine how these alterations correlate with the postoperative acoustic characteristics of patients' voices. By establishing a clear link between intraoperative signal dynamics and postoperative voice outcomes, the investigation aims to advance the field of thyroid surgery. This includes providing surgeons with critical insights for the precise evaluation of recurrent laryngeal nerve functionality, enabling targeted interventions during operations, and ultimately contributing to the enhancement of patients' quality of life following surgery. Through this rigorous analysis, the study seeks to contribute valuable knowledge to the surgical community, facilitating improved patient care and outcomes in thyroid surgery.
- Conditions
- Thyroid Cancer, Thyroid Cancer, Papillary
- Being tested
- Traditional thyroid surgery.
- Keywords
- acoustic analysis, thyroid cancer
- Medical subject headings
- Thyroid Neoplasms, Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional thyroid surgery.Procedure or surgery
The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology.
| Study group | Role | What they receive |
|---|---|---|
| Normal Signal Group. | During the surgical procedure, there was no occurrence of a decrease in recurrent laryngeal nerve signals or a decrease of less than 10%. Receives: Procedure: Traditional thyroid surgery. | |
| Signal Decrease 10-50%. | During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 10-50%. Receives: Procedure: Traditional thyroid surgery. | |
| Signal Decrease 50-90%. | During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 50-90%. Receives: Procedure: Traditional thyroid surgery. | |
| Signal Absence Group. | During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by more than 90% or completely disappeared. Receives: Procedure: Traditional thyroid surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative electromyographic signals.
Recording intraoperative electromyographic signals, including vagus nerve V1 and V2 signals, recurrent laryngeal nerve R1 and R2 signals.
Measured: During the surgery, record R1 and V1 signals when initially identifying the recurrent laryngeal nerve or vagus nerve. After the surgery, record R2 and V2 signals upon re-identification of the recurrent laryngeal nerve or vagus nerve.
Voice analysis data(SPL)
Recording data(SPL) of voice tests before and after the surgery, sound pressure level in dB(A)
Measured: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Voice analysis data(F0)
Recording data(F0) of voice tests before and after the surgery, F0 in Hz
Measured: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Voice analysis data(Jitter)
Recording data(Jitter) of voice tests before and after the surgery, Jitter in percentage
Measured: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Voice analysis data(Shimmer)
Recording data(Shimmer) of voice tests before and after the surgery, Shimmer in percentage
Measured: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Secondary outcomes (5)
RBH
Conducted by an otolaryngologist, the RBH assessment includes R (Roughness), B (Breathiness), and H (Hoarseness).
Measured: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
VHI-30
Voice Handicap Index, including a scale with 30 items.The full, non-abbreviated title of the VHI-30 scale is the "Voice Handicap Index-30," and it is translated as the "Voice Disorder Severity Index." The scale ranges from a minimum score of 0 to a maximum of 120, with higher scores indicating poorer outcomes.
Measured: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Neural Width
Recorded width of the recurrent laryngeal nerve in millimeters.
Measured: During surgery.
Is there branching
Note if the recurrent laryngeal nerve branches.
Measured: During surgery.
Number of neural branches
If there are branches in the recurrent laryngeal nerve, record the number of branches.
Measured: During surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Wang,MD, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254859
- Sponsor's protocol ID
- THYRO-SOUND2024
- Status last verified
- May 2025
- First submitted
- 30 Jan 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery
- ClinicalTrials.gov ID
- NCT06254859
- Acronym / sponsor ID
- THYRO-SOUND2024
- Conditions
- Thyroid Cancer, Thyroid Cancer, Papillary
- Keywords
- acoustic analysis, thyroid cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Feb 2024 (actual)
- 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.
This study examines the impact of intraoperative recurrent laryngeal nerve monitoring signal changes on the postoperative voice quality of thyroid surgery patients. By analyzing extensive surgical data and postoperative voice recordings, the investigation seeks to identify patterns in the variations of these signals and their correlation with voice quality outcomes. The goal is to enhance clinical understanding and surgical practices, allowing for more precise assessments of nerve function, informed surgical interventions, and improved postoperative patient well-being.
Detailed description
This research project conducts a detailed exploration into the fluctuations of intraoperative recurrent laryngeal nerve monitoring signals during thyroid surgery and their subsequent effects on the voice quality of patients after surgery. The study meticulously analyzes a comprehensive dataset comprised of surgical records and voice analyses conducted before and after the procedure. The primary objective is to pinpoint specific trends and changes in the nerve monitoring signals and to determine how these alterations correlate with the postoperative acoustic characteristics of patients' voices. By establishing a clear link between intraoperative signal dynamics and postoperative voice outcomes, the investigation aims to advance the field of thyroid surgery. This includes providing surgeons with critical insights for the precise evaluation of recurrent laryngeal nerve functionality, enabling targeted interventions during operations, and ultimately contributing to the enhancement of patients' quality of life following surgery. Through this rigorous analysis, the study seeks to contribute valuable knowledge to the surgical community, facilitating improved patient care and outcomes in thyroid surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Signal Group. | – | Procedure: Traditional thyroid surgery.During the surgical procedure, there was no occurrence of a decrease in recurrent laryngeal nerve signals or a decrease of less than 10%. |
| Signal Decrease 10-50%. | – | Procedure: Traditional thyroid surgery.During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 10-50%. |
| Signal Decrease 50-90%. | – | Procedure: Traditional thyroid surgery.During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 50-90%. |
| Signal Absence Group. | – | Procedure: Traditional thyroid surgery.During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by more than 90% or completely disappeared. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with thyroid cancer who are planned to undergo traditional surgical treatment.
Key inclusion criteria (2 listed)
- Age 20-60 years old.
- Planned conventional unilateral thyroid lobectomy + isthmus resection + central compartment lymph node dissection.
Key exclusion criteria (11 listed)
- History of past head and neck surgeries.
- Pronunciation system defect and disorder history.
- History of vocal cord polyps or nodules.
- History of upper respiratory tract infection in the 2 weeks before surgery or postoperative infection history.
- History of neurological disorders.
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 |
|---|---|---|
| Traditional thyroid surgery.The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology. | Procedure or surgery | Normal Signal Group., Signal Absence Group., Signal Decrease 10-50%., Signal Decrease 50-90%. |
Primary outcome
Intraoperative electromyographic signals.
Time frame: During the surgery, record R1 and V1 signals when initially identifying the recurrent laryngeal nerve or vagus nerve. After the surgery, record R2 and V2 signals upon re-identification of the recurrent laryngeal nerve or vagus nerve.
Recording intraoperative electromyographic signals, including vagus nerve V1 and V2 signals, recurrent laryngeal nerve R1 and R2 signals.
Voice analysis data(SPL)
Time frame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Recording data(SPL) of voice tests before and after the surgery, sound pressure level in dB(A)
Voice analysis data(F0)
Time frame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Recording data(F0) of voice tests before and after the surgery, F0 in Hz
Voice analysis data(Jitter)
Time frame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Recording data(Jitter) of voice tests before and after the surgery, Jitter in percentage
Voice analysis data(Shimmer)
Time frame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Recording data(Shimmer) of voice tests before and after the surgery, Shimmer in percentage
5 secondary outcomes
RBH
Time frame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
VHI-30
Time frame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
Neural Width
Time frame: During surgery.
Is there branching
Time frame: During surgery.
Number of neural branches
Time frame: During surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer and Thyroid Cancer, Papillary, run by Fujian Medical University at 1 site in China.
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 11 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: looking for participants now, as of the sponsor's last update on 20 May 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Wang Professor, MD (+13959123550, wangbo@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative electromyographic signals. (time frame: During the surgery, record R1 and V1 signals when initially identifying the recurrent laryngeal nerve or vagus nerve. After the surgery, record R2 and V2 signals upon re-identification of the recurrent laryngeal nerve or vagus nerve.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2025.