Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cases Patients who are going to undergo a thyroid surgery due to symptomatic non-toxic multinodular goiter, uncontrolled thyrotoxicosis or suspicious FNA |
Procedure: Thyroidectomy
Thyroidectomy
|
| Controls Patients with benign thyroid disease, not undergoing thyroidectomy |
Outcome Measures
Primary Outcome Measures
- Alterations in Quality of Life after thyroidectomy for benign thyroid disease [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 Outcome Measures
- Correlation of alterations in Quality of Life after thyroidectomy for benign thyroid disease with secondary characteristics of the patients [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient is over 18 years old
-
Patient scheduled for a non-emergency operation
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Patient diagnosed with benign thyroid disease
Exclusion Criteria:
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Patient is participating in another clinical trial which may affect this study's outcomes
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Patient with thyroid cancer
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Previous operation at the thyroid and parathyroid glands or neck irradiation
-
Patient unable to read and write in Greek
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ahepa Hospital | Thessaloníki | Central Macedonia | Greece | 54453 |
Sponsors and Collaborators
- Aristotle University Of Thessaloniki
Investigators
- Principal Investigator: Theodosios Papavramidis, Asst. Prof., Aristotle University Of Thessaloniki
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 26181