Recruiting

Observational StudyVoice Outcomes Following Thyroidectomy

Sponsor:

University of Virginia

Code:

NCT03657654

Conditions

Thyroid Cancer

Thyroid Nodule

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No intervention: observational only

Study Details

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.

Conditions

Thyroid Cancer

Thyroid Nodule

Study ID

NCT03657654

Start date

Apr 23, 2019

Status verified date

May, 2022

Completion date

Dec 15, 2023

Anticipated

Primary completion date

Dec 15, 2023

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

Thyroidectomy

Patients that are clinically referred for a thyroidectomy for known or potential cancer.

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

Interventions

No intervention: observational only

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 ]

Central Contacts and Locations

Central contacts

Bette F Ghamandi

434-243-1558 bjf8j@hscmail.mcc.virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Bette F Ghamandi, MHA, CCRP

434-243-1558 bjf8j@hscmail.mcc.virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

May 9, 2022

Last verified

May, 2022

Keywords

Thyroidectomy
Laryngeal Nerves
Voice problems

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2022-05-09.