Clinical trial NCT06254859: Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery
Official title: Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Cancer
Thyroid Cancer, Papillary
Keywords: acoustic analysis
thyroid cancer
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with thyroid cancer who are planned to undergo traditional surgical treatment.

Brief 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.

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.

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.

Primary outcomes:
measure: Intraoperative electromyographic signals.
timeFrame: 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.
measure: Voice analysis data(SPL)
timeFrame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
measure: Voice analysis data(F0)
timeFrame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
measure: Voice analysis data(Jitter)
timeFrame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
measure: Voice analysis data(Shimmer)
timeFrame: 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:
measure: RBH
timeFrame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
measure: VHI-30
timeFrame: Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
measure: Neural Width
timeFrame: During surgery.
measure: Is there branching
timeFrame: During surgery.
measure: Number of neural branches
timeFrame: During surgery.
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References: