Swallowing and Voice Outcomes After Thyroidectomy

Functional Voice and Swallowing Outcomes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436186
• Other study ID #: tgumus1
• Status: Completed
• Phase: N/A
• First received: February 3, 2018
• Last updated: February 15, 2018
• Start date: January 1, 2013
• Est. completion date: June 30, 2015

Study information

• Verified date: February 2018
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

according to the study, even in the absence of recurrent laryngeal nerve injury, subjective and objective swallowing and voice alterations do occur after thyroidectomy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 30, 2015
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 27 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Functional Voice and Swallowing Outcomes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the intake of fluid and thickened liquid food	comparison of the intake of fluid and thickened liquid food between pre- and post-operative scores	6 months
Primary	light and moderate residual accumulation in solid food intake	comparison of light and moderate residual accumulation in solid food intake between groups	6 months
Primary	functional oral intake score	comparison of functional oral intake score of specific functional limitation between groups	6 months
Primary	voice evaluation	comparison of standard deviation of average, fundamental frequency and degree of subharmonics between groups	6 months
Primary	Swallowing impairment score (SIS)	comparison of Swallowing impairment score (SIS) between pre- and post-operative groups	6 months
Primary	MD Anderson dysphagia inventory (MDADI)	comparison of MD Anderson dysphagia inventory (MDADI) between pre- and post-operative groups	6 months
Secondary	objective and subjective values correlation	Subjective data showed no correlation with objective findings (p>0.05)	6 months