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

NCT ID: NCT06254859

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-12-31

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.

Conditions

Thyroid Cancer; Thyroid Cancer, Papillary

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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%.

Traditional thyroid surgery.

Intervention Type: PROCEDURE

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

Signal Decrease 10-50%.

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

Traditional thyroid surgery.

Intervention Type: PROCEDURE

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

Signal Decrease 50-90%.

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

Traditional thyroid surgery.

Intervention Type: PROCEDURE

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

Signal Absence Group.

During the surgical procedure, the signal of the recurrent laryngeal nerve decreased by more than 90% or completely disappeared.

Traditional thyroid surgery.

Intervention Type: PROCEDURE

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

Interventions

Traditional thyroid surgery.

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

Intervention Type: PROCEDURE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Bo Wang,MD

Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bo Wang Professor, MD

Role: CONTACT

wangbo@fjmu.edu.cn

+13959123550

Facility Contacts

Bo Wang Porfessor, MD

Role: primary

wangbo@fjmu.edu.cn

+13959123550

Other Identifiers

THYRO-SOUND2024

Identifier Type: -

Identifier Source: org_study_id