Thyroid DiseaseNCT04635813
The Impact of COVID-19 Pandemic on Thyroid Surgery in Italy: Results From a Nation-wide Multicentric Study
An observational study of Thyroid Disease, run by University of Cagliari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Disease
- What is being tested?
- Thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 3,800 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2020to 12 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with thyroid disease
Who may be able to join
- 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.
Who cannot join
- incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Thyroid Disease
- Being tested
- Thyroidectomy
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyroidectomyProcedure or surgery
Thyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - COVID group | Patients that underwent surgery during COVID-19 pandemic Receives: Procedure: Thyroidectomy | |
| Group 2 - control group | Patients that underwent surgery during 2019 Receives: Procedure: Thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify the overall reduction of surgical activity for thyroid disease
Measured: 1 year
Secondary outcomes (2)
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
Measured: 1 year
Quantify the number of aggressive tumors operated during COVID-19 pandemic and the same period of the previous 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start10 Mar 2020
- Primary completion30 Sep 2020
- Study completion12 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Medas, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635813
- Sponsor's protocol ID
- THYCOVIT
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of COVID-19 Pandemic on Thyroid Surgery in Italy: Results From a Nation-wide Multicentric Study
- ClinicalTrials.gov ID
- NCT04635813
- Acronym / sponsor ID
- THYCOVIT
- Conditions
- Thyroid Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,800 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - COVID group | – | Procedure: ThyroidectomyPatients that underwent surgery during COVID-19 pandemic |
| Group 2 - control group | – | Procedure: ThyroidectomyPatients that underwent surgery during 2019 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with thyroid disease
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- incomplete data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThyroidectomyThyroidectomy | Procedure or surgery | Group 1 - COVID group, Group 2 - control group |
Primary outcome
Quantify the overall reduction of surgical activity for thyroid disease
Time frame: 1 year
2 secondary outcomes
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
Quantify the number of aggressive tumors operated during COVID-19 pandemic and the same period of the previous year
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Disease, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify the overall reduction of surgical activity for thyroid disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.