Voice Outcomes Following Thyroidectomy

NCT ID: NCT03657654

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-23
• Study Completion Date: 2023-12-15

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.

Conditions

Thyroid Cancer; Thyroid Nodule

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Thyroidectomy

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

No intervention: observational only

Intervention Type: 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

No intervention: observational only

Intervention Type: OTHER

No intervention: observational only

Interventions

No intervention: observational only

No intervention: observational only

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

David Shonka, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David C Shonka, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bette F Ghamandi

Role: CONTACT

bjf8j@hscmail.mcc.virginia.edu

434-243-1558

Facility Contacts

Bette F Ghamandi, MHA, CCRP

Role: primary

bjf8j@hscmail.mcc.virginia.edu

434-243-1558

Other Identifiers

20892

Identifier Type: -

Identifier Source: org_study_id