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Clinical Trials/NCT03566537
NCT03566537
Completed
Not Applicable

Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease

Aristotle University Of Thessaloniki1 site in 1 country73 target enrollmentJune 11, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Benign Thyroid Nodule
Sponsor
Aristotle University Of Thessaloniki
Enrollment
73
Locations
1
Primary Endpoint
Alterations in Quality of Life after thyroidectomy for benign thyroid disease
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 11, 2018
End Date
January 11, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Papavramidis Theodossis

Assistant Professor of surgery

Aristotle University Of Thessaloniki

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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