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临床试验/NCT03566537
NCT03566537已完成不适用

Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2018年6月11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
73
试验地点
1
主要终点
Alterations in Quality of Life after thyroidectomy for benign thyroid disease

研究概览

简要总结

To detect any changes in Quality of Life in patients with benign thyroid diseases who undergo thyroidectomy compared to patients with benign thyroid diseases and conservative treatment and healthy subjects.

详细描述

Benign thyroid diseases are a common public health problem. It has been reported that thyroid diseases can affect Quality of Life (QoL), but this is not easy to be assessed. Therefore, a valid instrument is necessary. Such an instrument is Thyroid-related patient-reported outcomes questionnaire (ThyPRO). ThyPRO has been recently translated and validated in Greek language. The questionnaire consists of 85 items grouped in 14 scales concerning goiter, hypothyroidism, hyperthyroidism and eye symptoms, tiredness, cognitive impairment, anxiety, depression, emotional susceptibility, cosmetic complaints and impaired social, and daily and sex life, as well as overall quality of life.

A few studies have demonstrated that various thyroid therapies may improve some aspects of QoL. The aim of the present study is to address the impact of thyroidectomy in QoL in patients with benign thyroid diseases.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Patient is over 18 years old
  • Patient scheduled for a non-emergency operation
  • Patient diagnosed with benign thyroid disease

排除标准

  • Patient is participating in another clinical trial which may affect this study's outcomes
  • Patient with thyroid cancer
  • Previous operation at the thyroid and parathyroid glands or neck irradiation
  • Patient unable to read and write in Greek

结局指标

主要结局

Alterations in Quality of Life after thyroidectomy for benign thyroid disease

时间窗: 2 years

To detect any changes in Quality of Life in patients with benign thyroid diseases who undergo thyroidectomy compared to patients with benign thyroid diseases and conservative treatment. The Greek, cross-cultural validated, version of ThyPRO questionnaire will be used, as it comprises a reliable and validated instrument to measure thyroid-related quality of life. The 84 questions of ThyPRO are categorized in 13 scales that involve: goiter, hypothyroidism, hyperthyroidism and eyes symptoms, tiredness, cognitive impairment, anxiety, depressivity, emotional susceptibility, cosmetic complaints and impaired social, and daily and sex life. The scales are all scored and the final scores were transformed to a scale from 0 to 100. Lower scores reflect a better thyroid-related quality of life, whereas higher scores reflect a worse quality of life.

次要结局

  • Correlation of alterations in Quality of Life after thyroidectomy for benign thyroid disease with secondary characteristics of the patients(2 years)

研究者

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

Papavramidis Theodossis

Assistant Professor of surgery

Aristotle University Of Thessaloniki

研究点 (1)

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