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CompletedNCT05996146HoarsenessUpdated Aug 21, 2023

Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study

An observational study in Hoarseness, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
427
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hoarseness

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Keywords

  • hoarseness
  • spine surgery
03

In context

Hoarseness

52 studies on the registry are indexed under Hoarseness; 9 are open to participants now.

Browse Hoarseness studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
427 participants (actual)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

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

    Time frame: 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

    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

    Time frame: one month after the surgery

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2022 to primary completion in Nov 2022, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2023
First posted
Aug 16, 2023
StartActual
May 5, 2022
Primary completionActual
Nov 27, 2022
CompletionActual
Jul 31, 2023
Last update
Aug 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05996146
Responsible party
Chun Kee Chung (Clinical Professor, Seoul National University Hospital) — Principal investigator
First posted
Aug 16, 2023
Start date
May 5, 2022
Primary completion
Nov 27, 2022
Completion
Jul 31, 2023
Last update
Aug 21, 2023

Study contacts

SUM KIM, Dr
principal investigator · Department of Neurosurgery, Seoul National University Hospital, Republic of Korea.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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