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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03566537
Other study ID # 26181
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 11, 2018
Est. completion date January 11, 2021

Study information

Verified date April 2021
Source Aristotle University Of Thessaloniki
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date January 11, 2021
Est. primary completion date June 11, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patient is over 18 years old 2. Patient scheduled for a non-emergency operation 3. Patient diagnosed with benign thyroid disease Exclusion Criteria: 1. Patient is participating in another clinical trial which may affect this study's outcomes 2. Patient with thyroid cancer 3. Previous operation at the thyroid and parathyroid glands or neck irradiation 4. Patient unable to read and write in Greek

Study Design


Intervention

Procedure:
Thyroidectomy
Thyroidectomy

Locations

Country Name City State
Greece Ahepa Hospital Thessaloníki Central Macedonia

Sponsors (1)

Lead Sponsor Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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. 2 years
Secondary Correlation of alterations in Quality of Life after thyroidectomy for benign thyroid disease with secondary characteristics of the patients 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) 2 years
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