Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease

Quality of Life Clinical Trial

Official title:

Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566537
• Other study ID #: 26181
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Benign Thyroid Nodule
• Quality of Life
• Thyroid Diseases
• Thyroid Nodule

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