NCT03657654

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

April 23, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

4.6 years

First QC Date

August 29, 2018

Last Update Submit

May 5, 2022

Conditions

Thyroid CancerThyroid Nodule

Keywords

ThyroidectomyLaryngeal NervesVoice problems

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 1 week following surgery, 3 months following surgery

Secondary Outcomes (5)

  • Video flexible nasolaryngoscopy

    Within 24 hours following surgery

  • Video nasolaryngeal stroboscopy

    Baseline, 1 week following surgery, 3 months following surgery

  • Vocal Aerodynamics Analysis

    Baseline, 1 week following surgery, 3 months following surgery

  • CAPE-V

    Baseline, 1 week following surgery, 3 months following surgery

  • CSL acoustics

    Baseline, 1 week following surgery, 3 months following surgery

Study Arms (2)

Thyroidectomy

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

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

Other: No intervention: observational only

Interventions

No intervention: observational onlyOTHER

No intervention: observational only

Other surgeriesThyroidectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid Nodule

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • David C Shonka, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bette F Ghamandi

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 5, 2018

Study Start

April 23, 2019

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)