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 and healthy subjects.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Benign Thyroid Nodule
• Intervention / Treatment: Procedure: Thyroidectomy

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 Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Greece
  • Central Macedonia
    • Thessaloníki, Central Macedonia, Greece, 54453
      • AHEPA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male or female subjects with benign thyroid diseases 18 years of age or older scheduled for thyroidectomy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Principal Investigator: Theodosios Papavramidis, Asst. Prof., Aristotle University Of Thessaloniki

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2018
• Primary Completion (ACTUAL): June 11, 2020
• Study Completion (ACTUAL): January 11, 2021

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (ACTUAL): June 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: 26181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No