Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study

NCT05996146 | Completed DMC

• 1 other identifier: HA-427
• Study Type: observational
• Target: 427
• Locations: 1 country
• Sites: 1

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.

Conditions

Hoarseness

Keywords

hoarseness; spine surgery

Outcome Measures

Primary Outcomes (1)

• the primary outcome was to measure the incidence of hoarseness

  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

  voice recordings six hours after the end of anesthesia

Secondary Outcomes (1)

• The secondary outcome involved measuring the incidence of hoarseness one month after the surgery

  one month after the surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Hoarseness

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Study Officials

• SUM KIM, Dr

  Department of Neurosurgery, Seoul National University Hospital, Republic of Korea.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 16, 2023
• Study Start: May 5, 2022
• Primary Completion: November 27, 2022
• Study Completion: July 31, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

KR (1)