ClinicalTrials.gg
RecruitingNCT06254859Updated May 20, 2025

Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery

An observational study in Thyroid Cancer and Thyroid Cancer, Papillary, sponsored by Fujian Medical University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-05-20.

Primary conditionThyroid Cancer, PapillaryRegistry: Thyroid NeoplasmsReclassifiedWhy we changed it
Registry
Thyroid Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Thyroid Cancer, Papillary
Why
  1. The study's listed conditions name Thyroid Cancer, Papillary, a narrower term within Thyroid Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Fujian Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 40 studies in Thyroid Cancer, Papillary with a site in China — 24 open to participants now, 26 under way, 1 of them phase 3. Thyroid Cancer, Papillary · China.

Planned enrollment
18th of 19
100 · median 541
Started
2024
with 9 others
Observational
19 of 40
15 open now
Primary completion
2025-12
later than 9 of 25 live
Registered
21st of 40
by date
Lead sponsor
4 of 40
Fujian Medical University

Among the 40 studies in Thyroid Cancer, Papillary with a site in China, this one is the 18th largest by planned enrollment of the 19 observational ones that give a count, is one of 10 that started in 2024, is one of 19 observational ones, reaches primary completion later than 9 of the 25 other live ones, and was the 21st registered.

Thyroid Cancer, Papillary

186 studies on the registry are indexed under Thyroid Cancer, Papillary; 51 are open to participants now.

Browse Thyroid Cancer, Papillary studies →

Open to participants now

24 of the 40 studies in Thyroid Cancer, Papillary with a site in China are open now. Recruiting first, the newest first:

18 more — sign in →

All 24 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 33 Thyroid Cancer, Papillary studies recruiting now, 20 (61%) set no upper age limit and 8 (24%) stop at 75 or younger; 15 take children under 18; 3 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 40 studies in Thyroid Cancer, Papillary with a site in China, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Thyroid Cancer
  • Thyroid Cancer, Papillary

Browse trials for

Keywords

  • acoustic analysis
  • thyroid cancer
04

In context

Thyroid Cancer, Papillary Reclassified

186 studies on the registry are indexed under Thyroid Cancer, Papillary; 51 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 66 observational studies indexed under Thyroid Cancer, Papillary.

Browse Thyroid Cancer, Papillary studies →

Lead sponsor

Fujian Medical University is the lead sponsor of 148 studies on the registry; 52 are open to participants now.

Compared within Thyroid Cancer, Papillary, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Thyroid Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

People with thyroid cancer who are planned to undergo traditional surgical treatment.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 20-60 years old.
  • Planned conventional unilateral thyroid lobectomy + isthmus resection + central compartment lymph node dissection.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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%.

    Procedure: Traditional thyroid surgery.

  • Signal Decrease 10-50%.

    During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 10-50%.

    Procedure: Traditional thyroid surgery.

  • Signal Decrease 50-90%.

    During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 50-90%.

    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.

    Procedure: Traditional thyroid surgery.

Interventions

  • ProcedureTraditional thyroid surgery.

    The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology.

07

What researchers measure

Primary outcomes

  1. Intraoperative electromyographic signals.

    Recording intraoperative electromyographic signals, including vagus nerve V1 and V2 signals, recurrent laryngeal nerve R1 and R2 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.

  2. Voice analysis data(SPL)

    Recording data(SPL) of voice tests before and after the surgery, sound pressure level in dB(A)

    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.

  3. Voice analysis data(F0)

    Recording data(F0) of voice tests before and after the surgery, F0 in Hz

    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.

  4. Voice analysis data(Jitter)

    Recording data(Jitter) of voice tests before and after the surgery, Jitter in percentage

    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.

  5. Voice analysis data(Shimmer)

    Recording data(Shimmer) of voice tests before and after the surgery, Shimmer in percentage

    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.

Secondary outcomes

  1. RBH

    Conducted by an otolaryngologist, the RBH assessment includes R (Roughness), B (Breathiness), and H (Hoarseness).

    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.

  2. 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.

    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.

  3. Neural Width

    Recorded width of the recurrent laryngeal nerve in millimeters.

    Time frame: During surgery.

  4. Is there branching

    Note if the recurrent laryngeal nerve branches.

    Time frame: During surgery.

  5. Number of neural branches

    If there are branches in the recurrent laryngeal nerve, record the number of branches.

    Time frame: During surgery.

08

Study locations

1 of 1 sites recruiting
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2024 (actual). Primary completion is estimated for Dec 2025, 21 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2024
First posted
Feb 12, 2024
StartActual
Mar 1, 2024
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
May 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06254859
Responsible party
Bo Wang,MD (Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor, Fujian Medical University) — Principal investigator
First posted
Feb 12, 2024
Start date
Mar 1, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
May 20, 2025

Study contacts

Bo Wang Professor, MD
Contact
wangbo@fjmu.edu.cn
+13959123550

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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