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Clinical Trials/NCT05178186
NCT05178186
Completed
Not Applicable

Impact of the COVID-19 Pandemic on Surgery for Thyroid Cancer: an International Multicenter Study

University of Cagliari1 site in 1 country22,974 target enrollmentJune 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroid Carcinoma
Sponsor
University of Cagliari
Enrollment
22974
Locations
1
Primary Endpoint
Incidence of aggressive thyroid cancers
Status
Completed
Last Updated
3 years ago

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
June 20, 2022
End Date
September 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fabio Medas

Associate Professor

University of Cagliari

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence of aggressive thyroid cancers

Time Frame: 36 months

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.

Study Sites (1)

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