Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease

NCT ID: NCT03566537

Last Updated: 2021-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-11

Study Completion Date

2021-01-11

Brief Summary

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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

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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.

Conditions

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Benign Thyroid Nodule Quality of Life

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

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

Thyroidectomy

Intervention Type PROCEDURE

Thyroidectomy

Controls

Patients with benign thyroid disease, not undergoing thyroidectomy

No interventions assigned to this group

Interventions

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Thyroidectomy

Thyroidectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Papavramidis Theodossis

Assistant Professor of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theodosios Papavramidis, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Aristotle University Of Thessaloniki

Locations

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Ahepa Hospital

Thessaloniki, Central Macedonia, Greece

Site Status

Countries

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Greece

Other Identifiers

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26181

Identifier Type: -

Identifier Source: org_study_id

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