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

F

Fujian Medical University

Status

Enrolling

Conditions

Thyroid Cancer, Papillary
Thyroid Cancer

Treatments

Procedure: Traditional thyroid surgery.

Study type

Observational

Funder types

Other

Identifiers

NCT06254859
THYRO-SOUND2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 4 patient groups

Normal Signal Group.
Description:
During the surgical procedure, there was no occurrence of a decrease in recurrent laryngeal nerve signals or a decrease of less than 10%.
Treatment:
Procedure: Traditional thyroid surgery.
Signal Decrease 10-50%.
Description:
During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 10-50%.
Treatment:
Procedure: Traditional thyroid surgery.
Signal Decrease 50-90%.
Description:
During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by 50-90%.
Treatment:
Procedure: Traditional thyroid surgery.
Signal Absence Group.
Description:
During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by more than 90% or completely disappeared.
Treatment:
Procedure: Traditional thyroid surgery.

Trial contacts and locations

1

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Central trial contact

Bo Wang Professor, MD

Data sourced from clinicaltrials.gov

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