Swallowing and Voice Outcomes After Thyroidectomy

February 15, 2018 updated by: Ozer Makay, Ege University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

43

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

27 years to 78 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who underwent thyroidectomy without recurren nerve injury

Description

Inclusion Criteria:

  • patients undergoing thyroidectomy

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
no arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months
functional oral intake score
Time Frame: 6 months
comparison of functional oral intake score of specific functional limitation between groups
6 months
voice evaluation
Time Frame: 6 months
comparison of standard deviation of average, fundamental frequency and degree of subharmonics between groups
6 months
Swallowing impairment score (SIS)
Time Frame: 6 months
comparison of Swallowing impairment score (SIS) between pre- and post-operative groups
6 months
MD Anderson dysphagia inventory (MDADI)
Time Frame: 6 months
comparison of MD Anderson dysphagia inventory (MDADI) between pre- and post-operative groups
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective and subjective values correlation
Time Frame: 6 months
Subjective data showed no correlation with objective findings (p>0.05)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

December 31, 2014

Study Completion (ACTUAL)

June 30, 2015

Study Registration Dates

First Submitted

February 3, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (ACTUAL)

February 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • tgumus1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

ı dont want to share for 2 years

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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