SurgeryNCT04344197
Surgery During Covid-19: The Role of Asymptomatic Patients, a Survey
An observational study of Surgery and COVID, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
a brief questionnaire to get a clearer picture of the situation regarding surgical patients with special emphasis on asymptomatic Covid-19 patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgery, COVID, Asymptomatic Patient
- What is being tested?
- global survey
- How many people
- 1,200 participants
- Where
- 1 siteItaly
- Study dates
- 2 Apr 2020to 15 Apr 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: surgeon
Who may be able to join
- general surgeon
Who cannot join
- other speciality
Trial locations and contacts
1 site in 1 country.
About this study
a brief questionnaire to get a clearer picture of the situation regarding surgical patients with special emphasis on asymptomatic Covid-19 patients.
Read the detailed description
With new evidence on the role of asymptomatic patients in spreading the disease during the Covid-19 pandemic, symptom driven guidelines for testing, hospital allocation and personal protective equipment (PPE) use do not seem appropriate to limit in-hospital transmission. At time when lockdowns are in place in most countries, hospitals can become the new source of infection.
Guidelines are very variable depending on local policies and availability of medical supplies, resulting in most hospitals taking different preventive measures.
- Conditions
- Surgery, COVID, Asymptomatic Patient, Covid-19, Preventive Measures
- Being tested
- global survey
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
global surveyOther
surgery questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
overview of surgical management on preventive measures of hospital infection spread during covid 19
Measured: 2/04/2020 to 15/04/2020
Secondary outcomes (1)
testing policies and preventive measures for Covid-19, and their association with asymptomatic cases.
Measured: 02/04/2020 to 15/04/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start2 Apr 2020
- Primary completion8 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Sigismondo Sica, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344197
- Sponsor's protocol ID
- s-covid survey
- Status last verified
- Dec 2020
- First submitted
- 9 Apr 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bellato V, Konishi T, Pellino G, An Y, Piciocchi A, Sensi B, Siragusa L, Khanna K, Pirozzi BM, Franceschilli M, Campanelli M, Efetov S, Sica GS; S-COVID Collaborative Group. Screening policies, preventive measures and in-hospital infection of COVID-19 in global surgical practices. J Glob Health. 2020 Dec;10(2):020507. doi: 10.7189/jogh.10.020507.
PubMed 33110590
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery During Covid-19: The Role of Asymptomatic Patients, a Survey
- ClinicalTrials.gov ID
- NCT04344197
- Acronym / sponsor ID
- s-covid survey
- Conditions
- Surgery, COVID, Asymptomatic Patient, Covid-19, Preventive Measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 14 Apr 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.
a brief questionnaire to get a clearer picture of the situation regarding surgical patients with special emphasis on asymptomatic Covid-19 patients.
Detailed description
With new evidence on the role of asymptomatic patients in spreading the disease during the Covid-19 pandemic, symptom driven guidelines for testing, hospital allocation and personal protective equipment (PPE) use do not seem appropriate to limit in-hospital transmission. At time when lockdowns are in place in most countries, hospitals can become the new source of infection.
Guidelines are very variable depending on local policies and availability of medical supplies, resulting in most hospitals taking different preventive measures.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- surgeon
Key inclusion criteria (1 listed)
- general surgeon
Key exclusion criteria (1 listed)
- other speciality
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 |
|---|---|---|
| global surveysurgery questionnaire | Other | – |
Primary outcome
overview of surgical management on preventive measures of hospital infection spread during covid 19
Time frame: 2/04/2020 to 15/04/2020
1 secondary outcome
testing policies and preventive measures for Covid-19, and their association with asymptomatic cases.
Time frame: 02/04/2020 to 15/04/2020
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 29 Dec 2020.
- Derived from this study: PubMed 33110590Bellato V, Konishi T, Pellino G, An Y, Piciocchi A, Sensi B, Siragusa L, Khanna K, Pirozzi BM, Franceschilli M, Campanelli M, Efetov S, Sica GS; S-COVID Collaborative Group. Screening policies, preventive measures and in-hospital infection of COVID-19 in global surgical practices. J Glob Health. 2020 Dec;10(2):020507. doi: 10.7189/jogh.10.020507.
- Individual participant dataSharing planned: Undecided
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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 Surgery and COVID, run by University of Rome Tor Vergata 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 29 Dec 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?
overview of surgical management on preventive measures of hospital infection spread during covid 19 (time frame: 2/04/2020 to 15/04/2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344197, which also lists 1 linked publication.
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 29 Dec 2020.