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The Impact of COVID-19 Pandemic on Thyroid Surgery in Italy: Results From a Nation-wide Multicentric Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04635813
Recruitment Status : Completed
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Fabio Medas, University of Cagliari

Study Description
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Brief Summary:
Italy has been on the frontline of the COVID-19 pandemic, caused by the coronavirus SARS-CoV-2, the need to focus resources to deal with the pandemic led to a disruption of routine surgical care, as well as activity for oncologic and chronic disease. The aim of this study was to evaluate the impact of COVID-19 pandemic on surgical activity of the Italian Units of Endocrine Surgery belonging to the SIUEC (Italian Society of Endocrine Surgery), the most important national scientific society of endocrine surgery.The aim of this study was to evaluate the impact of COVID-19 pandemic on surgical activity of the Italian Units of Endocrine Surgery belonging to the SIUEC (Italian Society of Endocrine Surgery), the most important national scientific society of endocrine surgery.

Condition or disease Intervention/treatment
Thyroid Disease Procedure: Thyroidectomy

Study Design
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Study Type : Observational
Actual Enrollment : 3800 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Impact of COVID-19 Pandemic on Thyroid Surgery in Italy: Results From a Nation-wide Multicentric Study
Actual Study Start Date : March 10, 2020
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : November 12, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1 - COVID group
Patients that underwent surgery during COVID-19 pandemic
 Procedure: Thyroidectomy
Thyroidectomy
Group 2 - control group
Patients that underwent surgery during 2019
 Procedure: Thyroidectomy
Thyroidectomy


Outcome Measures
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Primary Outcome Measures :
  1. Quantify the overall reduction of surgical activity for thyroid disease [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Quantify if the number of thyroid cancers operated during COVID-19 pandemic was significant different from the number of patients operated during the same period of the previous year [ Time Frame: 1 year ]
  2. Quantify the number of aggressive tumors operated during COVID-19 pandemic and the same period of the previous year [ Time Frame: 1 year ]
    Comparison between the number of patients operated during COVID-19 pandemic with aggressive thyroid carcinoma (with lymph node metastasis, and/or extrathyroidal extension, and/or multifocality) with patients with aggressive thyroid carcinoma operated during the same period of the previous year


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with thyroid disease
Criteria

Inclusion Criteria:

  • patients that had undergone thyroidectomy during COVID-19 pandemic (from the 9th March to the 31st August 2020), defined as case group, or during the same period of the previous year (from the 9th Match to the 31st August 2019), defined as control group.

Exclusion Criteria:

  • incomplete data
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635813


Locations
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Italy
AOU Cagliari
Cagliari, CA, Italy, 09100
Sponsors and Collaborators
University of Cagliari
More Information
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Responsible Party: Fabio Medas, Assistant Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT04635813    
Other Study ID Numbers: THYCOVIT
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Thyroid Diseases
Endocrine System Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases