Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study

Completed

• Conditions: Hoarseness

• Registration Number: NCT05996146
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Early diagnosis and appropriate treatment of hoarseness is known to improve quality of life and treatment outcomes. Therefore, appropriate research on the incidence of hoarseness after surgery is necessary. In this study, investigator aim to investigate incidence of hoarseness after spine surgery and the correlation between the Voice Handicap Index (VHI)-10, used as a criterion, and acoustic parameters, while also validating the efficacy of our research methods.

Detailed Description

The primary outcome of this study is the incidence of hoarseness on the day of surgery.

The secondary outcomes include the incidence of hoarseness at one month after surgery, as well as examining the correlation between acoustic parameters, risk factors, and the occurrence of hoarseness.

Investigator conducted a comparative analysis of risk factor for hoarseness in patients with different VHI-10 scores on the day of surgery and 30 days after surgery.

Study Timeline

• Study Start: 2022-05-05
• Primary Completion: 2022-11-27
• Study First Submitted: 2023-07-24
• Study Completion: 2023-07-31
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-13
• Study First Posted: 2023-08-16
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 427

Inclusion Criteria

• Age range is 20 to 80 years old
• degenerative spine conditions
• visit at Seoul National University Hospital only
• Patients who voluntarily consent to participate in the study

Exclusion Criteria

• History of surgery around the airway or mediastinum
• patients with vocal cord-related disorders
• Patients with fractures, bleeding, or other trauma
• Patients with neuromuscular diseases, Parkinson's disease, or psychiatric disorders
• Patients who cannot be extubated or who are transferred to the ICU after surgery
• Pregnant women
• Patients who do not wish to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the primary outcome was to measure the incidence of hoarseness	voice recordings six hours after the end of anesthesia	the primary outcome was to measure the incidence of voice disorders by conducting Voice Handicap Index-10 (minimum score 0 to maximum score 46, lower score is better) scoring and voice recordings six hours after the end of anesthesia

Secondary Outcome Measures

Name	Time	Method
The secondary outcome involved measuring the incidence of hoarseness one month after the surgery	one month after the surgery	analyzed the correlation between Voice Handicap Index-10 (minimum score 0 to maximum score 46, lower score is better) scores and voice acoustic parameter analysis

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of