Voice Outcomes Following Thyroidectomy
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Endocrine, Endocrine, Thyroid Cancer |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2018 |
| Start Date: | November 15, 2018 |
| End Date: | February 15, 2020 |
| Contact: | Bette F Ghamandi |
| Email: | bjf8j@hscmail.mcc.virginia.edu |
| Phone: | 434-243-1558 |
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.
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.
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.
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.
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
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