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Clinical Trials/NCT03436186
NCT03436186
Completed
Not Applicable

Objective Analysis of Swallowing and Functional Voice Outcomes After Thyroidectomy: A Prospective Cohort Study

Ege University0 sites43 target enrollmentJanuary 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Functional Voice and Swallowing Outcomes
Sponsor
Ege University
Enrollment
43
Primary Endpoint
functional oral intake score
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2013
End Date
June 30, 2015
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ozer Makay

ass. prof. ozer makay

Ege University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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

MD Anderson dysphagia inventory (MDADI)

Time Frame: 6 months

comparison of MD Anderson dysphagia inventory (MDADI) between pre- and post-operative groups

Swallowing impairment score (SIS)

Time Frame: 6 months

comparison of Swallowing impairment score (SIS) between pre- and post-operative groups

Secondary Outcomes

  • objective and subjective values correlation(6 months)

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