Clinical trial NCT03657654: Voice Outcomes Following Thyroidectomy
Official title: Voice Outcomes Following Thyroidectomy Compared to Surgeries That Do Not Involve Risk to the Laryngeal Nerves
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Cancer
Thyroid Nodule
Keywords: Thyroidectomy
Laryngeal Nerves
Voice problems
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Age ≥ 18 years
4. 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
5. 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

Exclusion Criteria:

1. Plan to include neck dissection in upcoming surgery (control group/non-thyroidectomy patients only)
2. Known to be pregnant

Primary outcomes:
measure: Change in Voice Handicap Index-10 (VHI-10) score before and after surgery
timeFrame: Baseline, 1 week following surgery, 3 months following surgery
Secondary outcomes:
measure: Video flexible nasolaryngoscopy
timeFrame: Within 24 hours following surgery
measure: Video nasolaryngeal stroboscopy
timeFrame: Baseline, 1 week following surgery, 3 months following surgery
measure: Vocal Aerodynamics Analysis
timeFrame: Baseline, 1 week following surgery, 3 months following surgery
measure: CAPE-V
timeFrame: Baseline, 1 week following surgery, 3 months following surgery
measure: CSL acoustics
timeFrame: Baseline, 1 week following surgery, 3 months following surgery
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: David C Shonka, MD
role: PRINCIPAL_INVESTIGATOR
References: