NCT04900233

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
651

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

Same day

First QC Date

May 15, 2021

Last Update Submit

May 23, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Number of patients admitted to the emergency department

    Variations in the consults the emergency department of general surgery.

    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.

    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.

    2019-2020

Study Arms (2)

Control group

Other: surgery

Pandemic group

Other: surgery

Interventions

surgeryOTHER

emergency surgery

Control groupPandemic group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

-patients over 18 years

You may qualify if:

  • 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).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1181ACH, Argentina

Location

MeSH Terms

Conditions

COVID-19EmergenciesAppendicitis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIntraabdominal InfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

May 15, 2021

First Posted

May 25, 2021

Study Start

May 6, 2021

Primary Completion

May 6, 2021

Study Completion

May 6, 2021

Last Updated

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations