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Completed

NCT Number: NCT03566537

Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease

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.

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Key information

Conditions

Benign Thyroid Nodule Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahepa Hospital

Thessaloniki, Central Macedonia, 54453, Greece

About this study

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.

Who can participate

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Thyroidectomy

Procedure

Thyroidectomy

Primary outcomes

  1. Alterations in Quality of Life after thyroidectomy for benign thyroid disease

    Time frame: 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.

Secondary outcomes

  1. Correlation of alterations in Quality of Life after thyroidectomy for benign thyroid disease with secondary characteristics of the patients

    Time frame: 2 years

    Correlation of alterations in Quality of Life after thyroidectomy for benign thyroid disease with secondary characteristics of the patients ( eg age, thyroid autoimmunity, thyroid function, Vitamin D levels)

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jun 25, 2018
Registry last updated
Apr 27, 2021

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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