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NCT04900233 Clinical Trial

Effect of Covid-19 Pandemic in Non Covid-19 Patients at the Emergency Surgical Department

Covid19 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04900233
Other study ID # 5684
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 6, 2021
Est. completion date May 6, 2021

Study information
Verified date May 2021
Source Hospital Italiano de Buenos Aires
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 651
Est. completion date May 6, 2021
Est. primary completion date May 6, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• surgery
emergency surgery

Locations
Country Name City State
Argentina Hospital Italiano de Buenos Aires Ciudad autónoma de Buenos Aires Buenos Aires

Sponsors (1)
Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients admitted to the emergency department Variations in the consults the emergency department of general surgery. 2019-2020
Primary Clinical presentation of the patients at the time of admission Surgical outcomes and severity of disease in admissions at the department of general surgery. 2019-2020
Primary 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. 2019-2020
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