Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease

Completed

• Conditions: Benign Thyroid Nodule; Quality of Life
• Interventions: Procedure: Thyroidectomy

• Registration Number: NCT03566537
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Study Start: 2018-06-11
• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-21
• Study First Posted: 2018-06-25
• Primary Completion: 2020-06-11
• Study Completion: 2021-01-11
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Thyroidectomy	Patients who are going to undergo a thyroid surgery due to symptomatic non-toxic multinodular goiter, uncontrolled thyrotoxicosis or suspicious FNA

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Ahepa Hospital; 🇬🇷 Thessaloníki, Central Macedonia, Greece