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Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05996146
Collaborator
(none)
427
Enrollment
1
Location
14.9
Actual Duration (Months)
28.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    427 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study
    Actual Study Start Date :
    May 5, 2022
    Actual Primary Completion Date :
    Nov 27, 2022
    Actual Study Completion Date :
    Jul 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    hoarseness group

    This study recruited all patients admitted at Seoul National University Hospital. Age range is 20 to 80 years old. Patients who require surgical treatment for degenerative spine conditions. Patients who voluntarily consent to participate in the study.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: SUM KIM, Dr, Department of Neurosurgery, Seoul National University Hospital, Republic of Korea.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chun Kee Chung, Clinical Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT05996146
    Other Study ID Numbers:
    • HA-427
    First Posted:
    Aug 16, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chun Kee Chung, Clinical Professor, Seoul National University Hospital
    hoarseness
    spine surgery
    Additional relevant MeSH terms:
    Hoarseness
    Dysphonia

    Study Results

    No Results Posted as of Aug 21, 2023