Alterations in Quality of Life After Thyroidectomy for Benign Thyroid Disease

NCT03566537 | Completed

• 1 other identifier: 26181
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Thyroid Nodule; Quality of Life

Outcome Measures

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.

  2 years

Secondary Outcomes (1)

• Correlation of alterations in Quality of Life after thyroidectomy for benign thyroid disease with secondary characteristics of the patients

  2 years

Study Arms (2)

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

Thyroidectomy PROCEDURE

Thyroidectomy

Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patient is over 18 years old
• Patient scheduled for a non-emergency operation
• Patient diagnosed with benign thyroid disease

You may not qualify if:

• Patient is participating in another clinical trial which may affect this study's outcomes
• Patient with thyroid cancer
• Previous operation at the thyroid and parathyroid glands or neck irradiation
• Patient unable to read and write in Greek

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Ahepa Hospital

Thessaloniki, Central Macedonia, 54453, Greece

Location

MeSH Terms

Interventions

Thyroidectomy

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Theodosios Papavramidis, Asst. Prof.

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of surgery

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 25, 2018
• Study Start: June 11, 2018
• Primary Completion: June 11, 2020
• Study Completion: January 11, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)