Thyroid CancerNCT03657654
Voice Outcomes Following Thyroidectomy
An observational study of Thyroid Cancer and Thyroid Nodule, run by University of Virginia at 1 site in United States.
Trial summary
This is an observational study of voice outcomes in participants following thyroidectomy or another head and neck surgery that does not involve risk to the larynx other than risks incurred due to intubation alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Thyroid Nodule
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2019to 15 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults that have been clinically referred for thyroidectomy or another surgery requiring intubation but without risk to the laryngeal nerves or dissection adjacent to the larynx.
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥ 18 years
- Subject must be clinically referred for a thyroidectomy for known or potential cancer, or subject must be clinically referred for a surgery requiring intubation, but without risk to the laryngeal nerves or dissection adjacent to the larynx for the control group
- As the VHI-10 is not available and validated in all languages, participants must be able to comprehend a validated version of the VHI-10 in their language
Who cannot join
- Plan to include neck dissection in upcoming surgery (control group/non-thyroidectomy patients only)
- Known to be pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Bette F Ghamandi, MHA, CCRP, 434-243-1558, bjf8j@hscmail.mcc.virginia.edu
James Daneiro, MD
About this study
Official title: Voice Outcomes Following Thyroidectomy Compared to Surgeries That Do Not Involve Risk to the Laryngeal Nerves
This is an observational study of voice outcomes in participants following thyroidectomy or another head and neck surgery that does not involve risk to the larynx other than risks incurred due to intubation alone. These comparative (non-thyroidectomy) surgeries would not be expected to interfere with the primary nerves involved with voice production, so they would help to better understand the effect of intubation alone on voice outcomes.
Read the detailed description
Voice difficulty is a common complaint following thyroidectomy, and while the procedure risks injury to laryngeal nerves involved in voice production, voice difficulty is common even in the absence of evident injury to these nerves. The cause of voice change in these situations is not well defined, and multiple mechanisms have been suggested. Some potential mechanisms include trauma to the laryngeal skeleton from intraoperative manipulation of the strap muscles, cricothyroid muscle, thyroid, cartilage, or trachea. However, it is also possible that irritation due to intubation and edema to the neck and oral or pharyngeal soft tissues that develops after the surgery as a result of intubation plays a role in postoperative voice change. These mechanisms can occur in any operation requiring general endotracheal anesthesia even when the laryngeal nerves are not specifically at risk of injury.
The purpose of this study is to evaluate voice outcomes after thyroidectomy (both objective and subjective patient and clinician reported) and compare those to voice outcomes after other surgeries that do not put the recurrent or superior laryngeal nerves at risk or traumatize the laryngeal skeleton, but do require general endotracheal anesthesia. The primary assessment tool will be the Voice Handicap Index-10 (VHI-10), which is a questionnaire that asks about the patient's interpretation of his/her voice quality and the impact it is having on daily activities. Data analysis will be done to see if participants have a significant change in their pre-operation VHI-10 score at approximately 1 week and 3 months post-operation. Additional assessments tools will include nasolaryngoscopy and nasolaryngeal stroboscopy to assess global vocal fold function, Consensus Auditory Perceptual Evaluation of Voice (CAPE-V) and computerized speech lab (CSL) acoustics to assess voice quality, and vocal aerodynamic analysis to determine air flow through the larynx.
- Conditions
- Thyroid Cancer, Thyroid Nodule
- Being tested
- No intervention: observational only
- Keywords
- Thyroidectomy, Laryngeal Nerves, Voice problems
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention: observational onlyOther
No intervention: observational only
| Study group | Role | What they receive |
|---|---|---|
| Thyroidectomy | Patients that are clinically referred for a thyroidectomy for known or potential cancer. Receives: Other: No intervention: observational only | |
| Other surgeries | Patients must be clinically referred for a surgery requiring intubation, but without risk to the laryngeal nerves or dissection adjacent to the larynx Receives: Other: No intervention: observational only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Voice Handicap Index-10 (VHI-10) score before and after surgery
This is a VHI-10 is a questionnaire that asks about the patient's interpretation of his/her voice quality and the impact it is having on daily activities.
Measured: Baseline, 1 week following surgery, 3 months following surgery
Secondary outcomes (5)
Video flexible nasolaryngoscopy
This procedure is endoscopic and allows for visualization and audio/video recording of the vocal folds at rest and during speech
Measured: Within 24 hours following surgery
Video nasolaryngeal stroboscopy
This imaging is another form of nasolaryngoscopy but has the addition of a strobe light. The strobe light provides an optical illusion in which the vocal cords appear to be moving in slow motion on the video, even though its movement is unaltered.
Measured: Baseline, 1 week following surgery, 3 months following surgery
Vocal Aerodynamics Analysis
This assessment is performed by fitting the participant with a mask that is attached to a tube that goes just inside the participant's lips. This positioning allows for the participant to close his/her lips around the tube without occluding it. The participant is asked to produce repeated syllables like pi-pi-pi-pi-pi, which allows for airflow and air pressure to be measured and reflects vocal fold function.
Measured: Baseline, 1 week following surgery, 3 months following surgery
CAPE-V
The CAPE-V is a tool used for clinical auditory-perceptual assessment of voice. It is intended to describe the severity of various auditory attributes of a voice problem, and it is determined by the clinician's auditory assessment of the patient's voice.
Measured: Baseline, 1 week following surgery, 3 months following surgery
CSL acoustics
This assessment involves having the participant speak into a microphone. The patient says a few scripted sentences, as well as repeated sounds, which is then analyzed by the computer software. The assessment allows for determination of vocal loudness, pitch, and voice quality. Voice quality is determined based on measures including vocal shimmer, vocal jitter, and background noise in the voice. Shimmer measures variation in voice amplitude and jitter measures variation in frequency.
Measured: Baseline, 1 week following surgery, 3 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start23 Apr 2019
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Shonka, MD, University of Virginia
- Investigators
- David C Shonka, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657654
- Sponsor's protocol ID
- 20892
- Status last verified
- May 2022
- First submitted
- 29 Aug 2018
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Outcomes Following Thyroidectomy Compared to Surgeries That Do Not Involve Risk to the Laryngeal Nerves
- ClinicalTrials.gov ID
- NCT03657654
- Acronym / sponsor ID
- 20892
- Conditions
- Thyroid Cancer, Thyroid Nodule
- Keywords
- Thyroidectomy, Laryngeal Nerves, Voice problems
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study of voice outcomes in participants following thyroidectomy or another head and neck surgery that does not involve risk to the larynx other than risks incurred due to intubation alone. These comparative (non-thyroidectomy) surgeries would not be expected to interfere with the primary nerves involved with voice production, so they would help to better understand the effect of intubation alone on voice outcomes.
Detailed description
Voice difficulty is a common complaint following thyroidectomy, and while the procedure risks injury to laryngeal nerves involved in voice production, voice difficulty is common even in the absence of evident injury to these nerves. The cause of voice change in these situations is not well defined, and multiple mechanisms have been suggested. Some potential mechanisms include trauma to the laryngeal skeleton from intraoperative manipulation of the strap muscles, cricothyroid muscle, thyroid, cartilage, or trachea. However, it is also possible that irritation due to intubation and edema to the neck and oral or pharyngeal soft tissues that develops after the surgery as a result of intubation plays a role in postoperative voice change. These mechanisms can occur in any operation requiring general endotracheal anesthesia even when the laryngeal nerves are not specifically at risk of injury.
The purpose of this study is to evaluate voice outcomes after thyroidectomy (both objective and subjective patient and clinician reported) and compare those to voice outcomes after other surgeries that do not put the recurrent or superior laryngeal nerves at risk or traumatize the laryngeal skeleton, but do require general endotracheal anesthesia. The primary assessment tool will be the Voice Handicap Index-10 (VHI-10), which is a questionnaire that asks about the patient's interpretation of his/her voice quality and the impact it is having on daily activities. Data analysis will be done to see if participants have a significant change in their pre-operation VHI-10 score at approximately 1 week and 3 months post-operation. Additional assessments tools will include nasolaryngoscopy and nasolaryngeal stroboscopy to assess global vocal fold function, Consensus Auditory Perceptual Evaluation of Voice (CAPE-V) and computerized speech lab (CSL) acoustics to assess voice quality, and vocal aerodynamic analysis to determine air flow through the larynx.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroidectomy | – | Other: No intervention: observational onlyPatients that are clinically referred for a thyroidectomy for known or potential cancer. |
| Other surgeries | – | Other: No intervention: observational onlyPatients must be clinically referred for a surgery requiring intubation, but without risk to the laryngeal nerves or dissection adjacent to the larynx |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults that have been clinically referred for thyroidectomy or another surgery requiring intubation but without risk to the laryngeal nerves or dissection adjacent to the larynx.
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥ 18 years
- Subject must be clinically referred for a thyroidectomy for known or potential cancer, or subject must be clinically referred for a surgery requiring intubation, but without risk to the laryngeal nerves or dissection adjacent to the larynx for the control group
- As the VHI-10 is not available and validated in all languages, participants must be able to comprehend a validated version of the VHI-10 in their language
Key exclusion criteria (2 listed)
- Plan to include neck dissection in upcoming surgery (control group/non-thyroidectomy patients only)
- Known to be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention: observational onlyNo intervention: observational only | Other | Other surgeries, Thyroidectomy |
Primary outcome
Change in Voice Handicap Index-10 (VHI-10) score before and after surgery
Time frame: Baseline, 1 week following surgery, 3 months following surgery
This is a VHI-10 is a questionnaire that asks about the patient's interpretation of his/her voice quality and the impact it is having on daily activities.
5 secondary outcomes
Video flexible nasolaryngoscopy
Time frame: Within 24 hours following surgery
Video nasolaryngeal stroboscopy
Time frame: Baseline, 1 week following surgery, 3 months following surgery
Vocal Aerodynamics Analysis
Time frame: Baseline, 1 week following surgery, 3 months following surgery
CAPE-V
Time frame: Baseline, 1 week following surgery, 3 months following surgery
CSL acoustics
Time frame: Baseline, 1 week following surgery, 3 months following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Shonka, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer and Thyroid Nodule, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bette F Ghamandi (434-243-1558, bjf8j@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Voice Handicap Index-10 (VHI-10) score before and after surgery (time frame: Baseline, 1 week following surgery, 3 months following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.