Covid19NCT04900233
Effect of Covid-19 Pandemic in Non Covid-19 Patients at the Emergency Surgical Department
An observational study of Covid19 and Emergencies, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Introduction Most countries imposed mandatory lockdowns that were rapidly lifted, however Argentina holds the record for one of the longest quarantines in the world. General surgery emergency conditions and trauma cases still require immediate evaluation and timely resolution. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Emergencies, Appendicitis
- What is being tested?
- surgery
- How many people
- 651 participants
- Where
- 1 siteArgentina
- Study dates
- 6 May 2021to 6 May 2021
- 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
- Child, Adult, Older adult
Study population: -patients over 18 years
Who may be able to join
- all non-Covid-19 patients over 18 years who consulted at the emergency surgical department of Hospital Italiano de Buenos Aires and required hospitalization in the period from March 13th, 2020 until July 31, 2020 (Pandemic Group-PG) and compared with the same period of 2019 (Control Group-CG).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1181ACH
About this study
Official title: Effect of Covid-19 Pandemic in Non Covid-19 Patients at the Emergency Surgical Department, During the Severe Restriction Phase of Lockdown in Buenos Aires. A Cohort Study.
Introduction Most countries imposed mandatory lockdowns that were rapidly lifted, however Argentina holds the record for one of the longest quarantines in the world. General surgery emergency conditions and trauma cases still require immediate evaluation and timely resolution. The primary objective of this study was to analyze the variations in the consults, surgical outcomes and severity of disease in admissions at our department of general surgery and to study the consequences of the lockdown effect in our community.
Materials and methods An observational, ambispective study was carried out on a prospective cohort of patients who consulted with on-call surgical pathology and required hospitalization in the period from March 13th, 2020 until July 31, 2020 (PG) were included, analyzed and compared with the same period of 2019 (CG).
Read the detailed description
Participation in the study does not represent any additional risk for the included participants since participation in the protocol does not include any experimental intervention and the medical care and treatment of all participants that require it will be carried out according to the current guidelines. The protocol does not contemplate any procedure or study additional to the usual care of the patient.
- Conditions
- Covid19, Emergencies, Appendicitis, Surgical Procedure, Unspecified
- Being tested
- surgery
- Medical subject headings
- COVID-19, Emergencies, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryOther
emergency surgery
| Study group | Role | What they receive |
|---|---|---|
| Control group | Not described Receives: Other: surgery | |
| Pandemic group | Not described Receives: Other: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients admitted to the emergency department
Variations in the consults the emergency department of general surgery.
Measured: 2019-2020
Clinical presentation of the patients at the time of admission
Surgical outcomes and severity of disease in admissions at the department of general surgery.
Measured: 2019-2020
Has the COVID-19 pandemic made a significant change in the hospital admissions?
Study the consequences of the severe restriction phase of the pandemic in the community.
Measured: 2019-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start6 May 2021
- Primary completion6 May 2021
- Study completion6 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Other
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CECILIA DANIELA JORGE, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900233
- Sponsor's protocol ID
- 5684
- Status last verified
- May 2021
- First submitted
- 15 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Covid-19 Pandemic in Non Covid-19 Patients at the Emergency Surgical Department, During the Severe Restriction Phase of Lockdown in Buenos Aires. A Cohort Study.
- ClinicalTrials.gov ID
- NCT04900233
- Acronym / sponsor ID
- 5684
- Conditions
- Covid19, Emergencies, Appendicitis, Surgical Procedure, Unspecified
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 25 May 2021 (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.
Introduction Most countries imposed mandatory lockdowns that were rapidly lifted, however Argentina holds the record for one of the longest quarantines in the world. General surgery emergency conditions and trauma cases still require immediate evaluation and timely resolution. The primary objective of this study was to analyze the variations in the consults, surgical outcomes and severity of disease in admissions at our department of general surgery and to study the consequences of the lockdown effect in our community.
Materials and methods An observational, ambispective study was carried out on a prospective cohort of patients who consulted with on-call surgical pathology and required hospitalization in the period from March 13th, 2020 until July 31, 2020 (PG) were included, analyzed and compared with the same period of 2019 (CG).
Detailed description
Participation in the study does not represent any additional risk for the included participants since participation in the protocol does not include any experimental intervention and the medical care and treatment of all participants that require it will be carried out according to the current guidelines. The protocol does not contemplate any procedure or study additional to the usual care of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: surgery |
| Pandemic group | – | Other: surgery |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- -patients over 18 years
Key inclusion criteria (1 listed)
- all non-Covid-19 patients over 18 years who consulted at the emergency surgical department of Hospital Italiano de Buenos Aires and required hospitalization in the period from March 13th, 2020 until July 31, 2020 (Pandemic Group-PG) and compared with the same period of 2019 (Control Group-CG).
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| surgeryemergency surgery | Other | Control group, Pandemic group |
Primary outcome
Number of patients admitted to the emergency department
Time frame: 2019-2020
Variations in the consults the emergency department of general surgery.
Clinical presentation of the patients at the time of admission
Time frame: 2019-2020
Surgical outcomes and severity of disease in admissions at the department of general surgery.
Has the COVID-19 pandemic made a significant change in the hospital admissions?
Time frame: 2019-2020
Study the consequences of the severe restriction phase of the pandemic in the community.
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 25 May 2021.
- 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 Covid19 and Emergencies, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 25 May 2021. 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 Argentina. 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?
Number of patients admitted to the emergency department (time frame: 2019-2020). The study lists 3 primary outcomes in all. 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 25 May 2021.