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Completed

NCT Number: NCT03436186

Swallowing and Voice Outcomes After Thyroidectomy

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.

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Key information

Conditions

Functional Voice and Swallowing Outcomes Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

27 year–78 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. functional oral intake score

    Time frame: 6 months

    comparison of functional oral intake score of specific functional limitation between groups

  4. voice evaluation

    Time frame: 6 months

    comparison of standard deviation of average, fundamental frequency and degree of subharmonics between groups

  5. Swallowing impairment score (SIS)

    Time frame: 6 months

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

  6. MD Anderson dysphagia inventory (MDADI)

    Time frame: 6 months

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

Secondary outcomes

  1. objective and subjective values correlation

    Time frame: 6 months

    Subjective data showed no correlation with objective findings (p>0.05)

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Feb 19, 2018
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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