EmergenciesNCT05476315
Emergency Surgery During Covid Compared to Emergency Surgery During Pre-covid Period
An observational study of Emergencies and Surgery, run by University of Foggia at 1 site in Italy.
Trial summary
The aim of this study is to analyze the trend of hospitalizations and how emergency operations have qualitatively and quantitatively changed in our Department of Medical and Surgical Sciences of the Foggia Hospital from 2019 (pre-covid era) to date. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Emergencies, Surgery, COVID-19
- What is being tested?
- Emergency surgery during covid-19 pandemic
- How many people
- 356 participants
- Where
- 1 siteItaly
- Study dates
- 9 Mar 2019to 9 May 2022
- 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: Our cohort-study was conducted by analyzing four groups of patients admitted to the Department of Medical and Surgical Sciences of the Hospital of Foggia, Apulia southern part of Italy : * group 1: people admitted during the no-covid period from March 09th, 2019 to May 09th, 2019; * group 2: people admitted from March 09th, 2020 to May 09th, 2020; * group 3: people admitted from March 09th, 2021 to May 09th, 2021 * group 4: people admitted from March 09th, 2022 to May 09th, 2022
Who may be able to join
- Patients underwent emergency surgery from March 2019 to May 2022
Who cannot join
- Patients underwent elective surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Emergency Surgery Back to Pre-covid-19 Era? Our Cohort Study
The aim of this study is to analyze the trend of hospitalizations and how emergency operations have qualitatively and quantitatively changed in our Department of Medical and Surgical Sciences of the Foggia Hospital from 2019 (pre-covid era) to date.
- Conditions
- Emergencies, Surgery, COVID-19
- Being tested
- Emergency surgery during covid-19 pandemic
- Medical subject headings
- Emergencies, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency surgery during covid-19 pandemicOther
Patients undergoing emergency surgery during the covid period and compared with emergency interventions before the pandemic
What is being measured
The primary outcome is the main question the study is designed to answer.
Is emergency surgery back to pre-covid-19 era?
How emergency surgery has changed during covid pandemic
Measured: From March 2019 to May 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start9 Mar 2019
- Primary completion9 May 2021
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanna Pavone, University of Foggia
- Investigators
- Giovanna Pavone, Principal investigator, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476315
- Sponsor's protocol ID
- 6
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Emergency Surgery Back to Pre-covid-19 Era? Our Cohort Study
- ClinicalTrials.gov ID
- NCT05476315
- Acronym / sponsor ID
- 6
- Conditions
- Emergencies, Surgery, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 9 Mar 2019 (actual)
- Primary completion
- 9 May 2021 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 27 Jul 2022 (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.
The aim of this study is to analyze the trend of hospitalizations and how emergency operations have qualitatively and quantitatively changed in our Department of Medical and Surgical Sciences of the Foggia Hospital from 2019 (pre-covid era) to date.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Our cohort-study was conducted by analyzing four groups of patients admitted to the Department of Medical and Surgical Sciences of the Hospital of Foggia, Apulia southern part of Italy : * group 1: people admitted during the no-covid period from March 09th, 2019 to May 09th, 2019; * group 2: people admitted from March 09th, 2020 to May 09th, 2020; * group 3: people admitted from March 09th, 2021 to May 09th, 2021 * group 4: people admitted from March 09th, 2022 to May 09th, 2022
Key inclusion criteria (1 listed)
- Patients underwent emergency surgery from March 2019 to May 2022
Key exclusion criteria (1 listed)
- Patients underwent elective surgery
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 |
|---|---|---|
| Emergency surgery during covid-19 pandemicPatients undergoing emergency surgery during the covid period and compared with emergency interventions before the pandemic | Other | – |
Primary outcome
Is emergency surgery back to pre-covid-19 era?
Time frame: From March 2019 to May 2022
How emergency surgery has changed during covid pandemic
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 27 Jul 2022.
- 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.
Giovanna Pavone principal investigator
University of Foggia
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 Emergencies and Surgery, run by University of Foggia 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 27 Jul 2022. 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?
Is emergency surgery back to pre-covid-19 era? (time frame: From March 2019 to May 2022). 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 27 Jul 2022.