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临床试验/NCT03436186
NCT03436186已完成不适用

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

Ege University0 个研究点目标入组 43 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
主要终点
functional oral intake score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
27 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing thyroidectomy

排除标准

  • 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

结局指标

主要结局

functional oral intake score

时间窗: 6 months

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

voice evaluation

时间窗: 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

时间窗: 6 months

comparison of light and moderate residual accumulation in solid food intake between groups

the intake of fluid and thickened liquid food

时间窗: 6 months

comparison of the intake of fluid and thickened liquid food between pre- and post-operative scores

MD Anderson dysphagia inventory (MDADI)

时间窗: 6 months

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

Swallowing impairment score (SIS)

时间窗: 6 months

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

次要结局

  • objective and subjective values correlation(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ozer Makay

ass. prof. ozer makay

Ege University

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