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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05178186
Other study ID # THYCOVID
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 20, 2022
Est. completion date September 15, 2022

Study information

Verified date December 2022
Source University of Cagliari
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The impact of the COVID-19 pandemic has heavily influenced routine medical care. In the first months of the pandemic, healthcare authorities restricted medical care to emergency procedures, postponing elective surgical activity. Conversely, screening programmes and planned examinations have been temporarily suspended or delayed. Gradually, elective surgery and clinical activities have resumed, thanks to the weakening of the pandemic, to a better organization of the healthcare systems and to the diffusion of COVID-19 vaccines. In the present study, we aim to evaluate the impact of the COVID-19 pandemic on surgery for thyroid carcinoma. Particularly, we aim to investigate whether the delay in operations, screening programmes, and planned examinations for patients under follow-up after thyroid surgery have led to an increased number of aggressive tumours. To evaluate this aspect, we aim to compare the patients who had undergone thyroidectomy for thyroid cancer before the COVID-19 pandemic (from February 2019 to February 2020), during the first phase of the pandemic (from March 2020 to September 2020), and after the first phase of the COVID-19 pandemic (from October 2020 to October 2021).


Recruitment information / eligibility

Status Completed
Enrollment 22974
Est. completion date September 15, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who have undergone thyroidectomy with preoperative diagnosis of thyroid cancer (cytological diagnosis, including Bethesda III, IV, IV or VI class, or high suspicion of thyroid carcinoma based on clinical and/or ultrasonographic features) during the study period (from February 2019 to October 2021) - Patients who underwent reoperative neck surgery for local recurrence of thyroid carcinoma during the study period (from February 2019 to October 2021) Exclusion Criteria: - Age < 18 yo - Incidental diagnosis of thyroid carcinoma

Study Design


Intervention

Procedure:
Thyroidectomy
Surgery for thyroid carcinoma

Locations

Country Name City State
Italy AOU Cagliari Cagliari CA

Sponsors (1)

Lead Sponsor Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of aggressive thyroid cancers Increase in the number of patients with aggressive thyroid carcinoma (intermediate and high risk of local recurrence, according to 2015 American Thyroid Association Guidelines on Thyroid Carcinoma), calculated as ratio between patients with aggressive thyroid carcinoma operated in pre-pandemic period and patients with aggressive thyroid carcinoma operated during covid-19 pandemic. 36 months
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