Swallowing and Voice Outcomes After Thyroidectomy

Completed

• Conditions: Functional Voice and Swallowing Outcomes

• Registration Number: NCT03436186
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2014-12-31
• Study Completion: 2015-06-30
• Status Verified: 2018-02
• Study First Submitted: 2018-02-03
• Study First Submitted QC: 2018-02-15
• Last Update Submitted: 2018-02-15
• Study First Posted: 2018-02-19
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
functional oral intake score	6 months	comparison of functional oral intake score of specific functional limitation between groups
voice evaluation	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	6 months	comparison of light and moderate residual accumulation in solid food intake between groups
the intake of fluid and thickened liquid food	6 months	comparison of the intake of fluid and thickened liquid food between pre- and post-operative scores
MD Anderson dysphagia inventory (MDADI)	6 months	comparison of MD Anderson dysphagia inventory (MDADI) between pre- and post-operative groups
Swallowing impairment score (SIS)	6 months	comparison of Swallowing impairment score (SIS) between pre- and post-operative groups

Secondary Outcome Measures

Name	Time	Method
objective and subjective values correlation	6 months	Subjective data showed no correlation with objective findings (p\>0.05)