Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Traditional thyroid surgery..
- Who it may be relevant to
- Registry conditions: Thyroid Cancer, Thyroid Cancer, Papillary. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Traditional thyroid surgery.
The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology.
Primary outcome measures
- 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.]
- 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.]
- 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.]
- 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.]
- 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.]
Secondary outcome measures (5)
- 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.]
Eligibility criteria
Inclusion criteria
- Age 20-60 years old.
- Planned conventional unilateral thyroid lobectomy + isthmus resection + central compartment lymph node dissection.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fujian Medical University Union Hospital — Fuzhou
Identifiers
NCT: NCT06254859 · THYRO-SOUND2024