- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04635813
The Impact of COVID-19 Pandemic on Thyroid Surgery in Italy: Results From a Nation-wide Multicentric Study
November 18, 2020 updated by: Fabio Medas, University of Cagliari
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
3800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
CA
-
Cagliari, CA, Italy, 09100
- AOU Cagliari
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with thyroid disease
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1 - COVID group
Patients that underwent surgery during COVID-19 pandemic
|
Thyroidectomy
|
Group 2 - control group
Patients that underwent surgery during 2019
|
Thyroidectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quantify the overall reduction of surgical activity for thyroid disease
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2020
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
November 12, 2020
Study Registration Dates
First Submitted
November 17, 2020
First Submitted That Met QC Criteria
November 18, 2020
First Posted (Actual)
November 19, 2020
Study Record Updates
Last Update Posted (Actual)
November 19, 2020
Last Update Submitted That Met QC Criteria
November 18, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THYCOVIT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Thyroidectomy
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-
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-
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-
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-
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