- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05930574
Implementation of an Epidemiological and Clinical Registry of Emergency Surgery Patients in a Costa Rican Hospital
June 30, 2023 updated by: María Rosario Espinoza Mora, Caja Costarricense de Seguro Social
Demographic and Clinical Characterization of Patients Operated by the General Surgery Service Who Were Admitted by the Emergency Service of the Dr. Rafael Ángel Calderón Guardia Hospital, 2021-2022.
A retrospective cross-sectional study was conducted in a quaternary level university hospital of the Costa Rican public health system.
The study included all patients aged 12 years and older who required emergency surgery by the hospital's emergency surgery and trauma service, admitted through the hospital's emergency service.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This research consists in a retrospective cross-sectional study carried out in a quarterly level university hospital of care of the Costa Rican public health system (high complexity).
The study included all patients aged 12 years or older who required emergency surgery for the hospital's emergency surgery and trauma service, admitted to this center between 2020 and 2022.
Only those patients who required emergency surgery by another surgical specialty during this period were excluded from the register.
A non-probabilistic convenience sampling was performed, based on the pre-established selection criteria and determined by the number of patients treated in the shock room of the hospital, that subsequently received general emergency or trauma surgery in the period under study.
Sociodemographic variables, hemodynamic status, period of hospitalization, related to the procedure performed and the underlying comorbidities, as well as the clinical outcome, were included in the study database.
Study Type
Observational
Enrollment (Actual)
575
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
San José, Costa Rica
- Unidad de Investigación en Salud, Hospital Dr. Rafael Angel Calderón Guardia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients requiring emergency surgery by the hospital's emergency surgery and trauma service, admitted through the hospital's emergency service.
Description
Inclusion Criteria:
- The study included all patients aged 12 years and older who required emergency surgery by the hospital's emergency surgery and trauma service, admitted through the hospital's emergency service.
Exclusion Criteria:
- . Only those patients who required emergency surgery by another surgical specialty during this period were excluded from the register.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: retrospective study (2020-2022)
|
Mortality rate after the surgical procedure during hospitalization
|
retrospective study (2020-2022)
|
Mechanical ventilation
Time Frame: retrospective study (2020-2022)
|
Days of mechanical ventilation needed
|
retrospective study (2020-2022)
|
Requirement of Intensive Care Unit
Time Frame: retrospective study (2020-2022)
|
Days of permanence in Intensive Care Unit
|
retrospective study (2020-2022)
|
Infections
Time Frame: retrospective study (2020-2022)
|
Infection rate after the surgical procedure during hospitalization
|
retrospective study (2020-2022)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2020
Primary Completion (Actual)
November 30, 2020
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
June 24, 2023
First Submitted That Met QC Criteria
June 30, 2023
First Posted (Actual)
July 5, 2023
Study Record Updates
Last Update Posted (Actual)
July 5, 2023
Last Update Submitted That Met QC Criteria
June 30, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-UIS-HCG-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The public health system of Costa Rica avoid sharing clinical data with external centers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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