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CompletedNCT03566537Updated Apr 27, 2021

Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease

An observational study in Benign Thyroid Nodule and Quality of Life, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-27.

Sponsored by Aristotle University Of Thessaloniki · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
73
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Benign Thyroid Nodule
  • Quality of Life
03

In context

Thyroid Nodule

200 studies on the registry are indexed under Thyroid Nodule; 57 are open to participants now.

This study's enrollment of 73 is below the median of 200 across 78 observational studies indexed under Thyroid Nodule.

Browse Thyroid Nodule studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
73 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Cases

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

    Procedure: Thyroidectomy

  • Controls

    Patients with benign thyroid disease, not undergoing thyroidectomy

Interventions

  • ProcedureThyroidectomy

    Thyroidectomy

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

Secondary outcomes

  1. 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)

    Time frame: 2 years

07

Study locations

1 site
  • Ahepa Hospital
    Thessaloníki, Central Macedonia 54453, Greece
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03566537
Lead sponsor
Aristotle University Of Thessaloniki
Responsible party
Papavramidis Theodossis (Assistant Professor of surgery, Aristotle University Of Thessaloniki) — Principal investigator
First posted
Jun 25, 2018
Start date
Jun 11, 2018
Primary completion
Jun 11, 2020
Completion
Jan 11, 2021
Last update
Apr 27, 2021

Study contacts

Theodosios Papavramidis, Asst. Prof.
principal investigator · Aristotle University Of Thessaloniki

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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