Functional Voice and Swallowing OutcomesNCT03436186
Swallowing and Voice Outcomes After Thyroidectomy
An observational study of Functional Voice and Swallowing Outcomes, run by Ege University.
Trial summary
Impairment in voice and swallowing functions are common after thyroidectomy. The investigators aimed to evaluate the objective functional voice and swallowing outcomes in a series of patients undergoing thyroidectomy. Read more about this study
- Who is it for?
- Ages 27 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Voice and Swallowing Outcomes
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 30 Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who underwent thyroidectomy without recurren nerve injury
Who may be able to join
- patients undergoing thyroidectomy
Who cannot join
- Patients who were diagnosed with thyroid carcinoma preoperatively
- Having history of previous neck surgery,
- History of radiotherapy at head and neck region,
- Vocal cord paralysis,
- neuromuscular dysfunction,
- larynx, esophagus and chest pathology
- who did not want to be involved in the study
About this study
Official title: Objective Analysis of Swallowing and Functional Voice Outcomes After Thyroidectomy: A Prospective Cohort Study
Impairment in voice and swallowing functions are common after thyroidectomy. The investigators aimed to evaluate the objective functional voice and swallowing outcomes in a series of patients undergoing thyroidectomy.
according to the study, even in the absence of recurrent laryngeal nerve injury, subjective and objective swallowing and voice alterations do occur after thyroidectomy.
Read the detailed description
A total of 43 consenting patients who underwent thyroidectomy were prospectively recruited. Subjective evaluation of swallowing was assessed with 'Swallowing Impairment Score' and 'MD Anderson Dysphagia Inventory'. Fiberoptic endoscopic evaluation of swallowing (FEES) was applied for objective evaluation. Also, functional oral intake scale (FOIS) and functional outcome swallowing scale (FOSS) were used for swallowing assessment. Voice evaluation was assessed with videostrobolaryngoscopy (VSL) and 'The Multi-Dimensional Voice Program (MDVP)' was used for capturing and analyzing the voice samples. All evaluations were performed preoperatively and on 1st day, 2nd week and 6th months postoperatively.
- Conditions
- Functional Voice and Swallowing Outcomes
- Keywords
- Thyroidectomy, voice, swallowing problems, dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
no intervention
| Study group | Role | What they receive |
|---|---|---|
| no arm | no arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
the intake of fluid and thickened liquid food
comparison of the intake of fluid and thickened liquid food between pre- and post-operative scores
Measured: 6 months
light and moderate residual accumulation in solid food intake
comparison of light and moderate residual accumulation in solid food intake between groups
Measured: 6 months
functional oral intake score
comparison of functional oral intake score of specific functional limitation between groups
Measured: 6 months
voice evaluation
comparison of standard deviation of average, fundamental frequency and degree of subharmonics between groups
Measured: 6 months
Swallowing impairment score (SIS)
comparison of Swallowing impairment score (SIS) between pre- and post-operative groups
Measured: 6 months
MD Anderson dysphagia inventory (MDADI)
comparison of MD Anderson dysphagia inventory (MDADI) between pre- and post-operative groups
Measured: 6 months
Secondary outcomes (1)
objective and subjective values correlation
Subjective data showed no correlation with objective findings (p>0.05)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Jan 2013
- Primary completion31 Dec 2014
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Voice and Swallowing OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozer Makay, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436186
- Sponsor's protocol ID
- tgumus1
- Status last verified
- Feb 2018
- First submitted
- 3 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: ı dont want to share for 2 years
Publications
Gumus T, Makay O, Eyigor S, Ozturk K, Erdogan Cetin Z, Sezgin B, Kolcak Z, Icoz G, Akyildiz M. Objective analysis of swallowing and functional voice outcomes after thyroidectomy: A prospective cohort study. Asian J Surg. 2020 Jan;43(1):116-123. doi: 10.1016/j.asjsur.2019.04.013. Epub 2019 May 23.
PubMed 31130500
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Analysis of Swallowing and Functional Voice Outcomes After Thyroidectomy: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03436186
- Acronym / sponsor ID
- tgumus1
- Conditions
- Functional Voice and Swallowing Outcomes
- Keywords
- Thyroidectomy, voice, swallowing problems, dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Impairment in voice and swallowing functions are common after thyroidectomy. The investigators aimed to evaluate the objective functional voice and swallowing outcomes in a series of patients undergoing thyroidectomy.
according to the study, even in the absence of recurrent laryngeal nerve injury, subjective and objective swallowing and voice alterations do occur after thyroidectomy.
Detailed description
A total of 43 consenting patients who underwent thyroidectomy were prospectively recruited. Subjective evaluation of swallowing was assessed with 'Swallowing Impairment Score' and 'MD Anderson Dysphagia Inventory'. Fiberoptic endoscopic evaluation of swallowing (FEES) was applied for objective evaluation. Also, functional oral intake scale (FOIS) and functional outcome swallowing scale (FOSS) were used for swallowing assessment. Voice evaluation was assessed with videostrobolaryngoscopy (VSL) and 'The Multi-Dimensional Voice Program (MDVP)' was used for capturing and analyzing the voice samples. All evaluations were performed preoperatively and on 1st day, 2nd week and 6th months postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no arm | – | –no arm |
Who may qualify
- Ages
- 27 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent thyroidectomy without recurren nerve injury
Key inclusion criteria (1 listed)
- patients undergoing thyroidectomy
Key exclusion criteria (7 listed)
- Patients who were diagnosed with thyroid carcinoma preoperatively
- Having history of previous neck surgery,
- History of radiotherapy at head and neck region,
- Vocal cord paralysis,
- neuromuscular dysfunction,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | no arm |
Primary outcome
the intake of fluid and thickened liquid food
Time frame: 6 months
comparison of the intake of fluid and thickened liquid food between pre- and post-operative scores
light and moderate residual accumulation in solid food intake
Time frame: 6 months
comparison of light and moderate residual accumulation in solid food intake between groups
functional oral intake score
Time frame: 6 months
comparison of functional oral intake score of specific functional limitation between groups
voice evaluation
Time frame: 6 months
comparison of standard deviation of average, fundamental frequency and degree of subharmonics between groups
Swallowing impairment score (SIS)
Time frame: 6 months
comparison of Swallowing impairment score (SIS) between pre- and post-operative groups
MD Anderson dysphagia inventory (MDADI)
Time frame: 6 months
comparison of MD Anderson dysphagia inventory (MDADI) between pre- and post-operative groups
1 secondary outcome
objective and subjective values correlation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Derived from this study: PubMed 31130500Gumus T, Makay O, Eyigor S, Ozturk K, Erdogan Cetin Z, Sezgin B, Kolcak Z, Icoz G, Akyildiz M. Objective analysis of swallowing and functional voice outcomes after thyroidectomy: A prospective cohort study. Asian J Surg. 2020 Jan;43(1):116-123. doi: 10.1016/j.asjsur.2019.04.013. Epub 2019 May 23.
- Individual participant dataSharing planned: Undecided. ı dont want to share for 2 years
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Voice and Swallowing Outcomes, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the intake of fluid and thickened liquid food (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03436186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018; AzTrials last refreshed its copy on 30 Oct 2026.