Implementation of an Epidemiological and Clinical Registry of Emergency Surgery Patients in a Costa Rican Hospital

• Sponsor: Caja Costarricense de Seguro Social (Other)
• Overall Status: Completed
• CT.gov ID: NCT05930574
• Collaborator: (none)
• Enrollment: 575
• Location: 1
• Actual Duration (Months): 32
• Patients Per Site Per Month: 18

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Complication; Emergencies	Procedure: Abdominal surgery

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 575 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: 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.
• Actual Study Start Date: May 1, 2020
• Actual Primary Completion Date: Nov 30, 2020
• Actual Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. Mortality [retrospective study (2020-2022)]

   Mortality rate after the surgical procedure during hospitalization

2. Mechanical ventilation [retrospective study (2020-2022)]

   Days of mechanical ventilation needed

3. Requirement of Intensive Care Unit [retrospective study (2020-2022)]

   Days of permanence in Intensive Care Unit

4. Infections [retrospective study (2020-2022)]

   Infection rate after the surgical procedure during hospitalization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unidad de Investigación en Salud, Hospital Dr. Rafael Angel Calderón Guardia	San José		Costa Rica

Sponsors and Collaborators

• Caja Costarricense de Seguro Social

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: María Rosario Espinoza Mora, Head of the Health Investigation Department, Hospital Dr. Rafael Angel Calderón Guardia, Caja Costarricense de Seguro Social
• ClinicalTrials.gov Identifier: NCT05930574
• Other Study ID Numbers: 01-UIS-HCG-2023
• First Posted: Jul 5, 2023
• Last Update Posted: Jul 5, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by María Rosario Espinoza Mora, Head of the Health Investigation Department, Hospital Dr. Rafael Angel Calderón Guardia, Caja Costarricense de Seguro Social: Registry; Trauma; General surgery; Emergency
• Additional relevant MeSH terms: Emergencies

Study Results

No Results Posted as of Jul 5, 2023