Surgical ComplicationNCT05930574
Implementation of an Epidemiological and Clinical Registry of Emergency Surgery Patients in a Costa Rican Hospital
An observational study of Surgical Complication and Emergencies, run by Caja Costarricense de Seguro Social at 1 site in Costa Rica.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Surgical Complication, Emergencies
- What is being tested?
- Abdominal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 575 participants
- Where
- 1 siteCosta Rica
- Study dates
- 1 May 2020to 31 Dec 2022
- How long will I take part?
- 2 Years
- 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 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients requiring emergency surgery by the hospital's emergency surgery and trauma service, admitted through the hospital's emergency service.
Who may be able to join
- 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.
Who cannot join
- . Only those patients who required emergency surgery by another surgical specialty during this period were excluded from the register.
Trial locations and contacts
1 site in 1 country.
Costa Rica1 site
Unidad de Investigación en Salud, Hospital Dr. Rafael Angel Calderón Guardia
San José
About this study
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.
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.
Read the 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.
- Conditions
- Surgical Complication, Emergencies
- Being tested
- Abdominal surgery
- Keywords
- Registry, Trauma, General surgery, Emergency
- Medical subject headings
- Emergencies, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal surgeryProcedure or surgery
surgical interventions by gastrointestinal emergencies, hepatobiliary emergencies and trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality rate after the surgical procedure during hospitalization
Measured: retrospective study (2020-2022)
Mechanical ventilation
Days of mechanical ventilation needed
Measured: retrospective study (2020-2022)
Requirement of Intensive Care Unit
Days of permanence in Intensive Care Unit
Measured: retrospective study (2020-2022)
Infections
Infection rate after the surgical procedure during hospitalization
Measured: retrospective study (2020-2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 May 2020
- Primary completion30 Nov 2020
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical ComplicationStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 575 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Caja Costarricense de Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, María Rosario Espinoza Mora, Caja Costarricense de Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930574
- Sponsor's protocol ID
- 01-UIS-HCG-2023
- Status last verified
- Jun 2023
- First submitted
- 24 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The public health system of Costa Rica avoid sharing clinical data with external centers.
Publications
Melendez Lugo JJ, Castro-Blanco L, Pineda Hernandez AP, Espinoza-Mora MDR. Clinical profile, outcomes and mortality determinants among emergency general surgery patients in a Latin American tertiary hospital: a retrospective registry-based cross-sectional study. BMC Surg. 2026 Jul 8. doi: 10.1186/s12893-026-03949-2. Online ahead of print.
PubMed 42415008
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05930574
- Acronym / sponsor ID
- 01-UIS-HCG-2023
- Conditions
- Surgical Complication, Emergencies
- Keywords
- Registry, Trauma, General surgery, Emergency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Caja Costarricense de Seguro SocialOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Jul 2023 (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.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients requiring emergency surgery by the hospital's emergency surgery and trauma service, admitted through the hospital's emergency service.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- . Only those patients who required emergency surgery by another surgical specialty during this period were excluded from the register.
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 |
|---|---|---|
| Abdominal surgerysurgical interventions by gastrointestinal emergencies, hepatobiliary emergencies and trauma | Procedure or surgery | – |
Primary outcome
Mortality
Time frame: retrospective study (2020-2022)
Mortality rate after the surgical procedure during hospitalization
Mechanical ventilation
Time frame: retrospective study (2020-2022)
Days of mechanical ventilation needed
Requirement of Intensive Care Unit
Time frame: retrospective study (2020-2022)
Days of permanence in Intensive Care Unit
Infections
Time frame: retrospective study (2020-2022)
Infection rate after the surgical procedure during hospitalization
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 5 Jul 2023.
- Derived from this study: PubMed 42415008Melendez Lugo JJ, Castro-Blanco L, Pineda Hernandez AP, Espinoza-Mora MDR. Clinical profile, outcomes and mortality determinants among emergency general surgery patients in a Latin American tertiary hospital: a retrospective registry-based cross-sectional study. BMC Surg. 2026 Jul 8. doi: 10.1186/s12893-026-03949-2. Online ahead of print.
- Individual participant dataSharing planned: No. The public health system of Costa Rica avoid sharing clinical data with external centers.
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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 Surgical Complication and Emergencies, run by Caja Costarricense de Seguro Social at 1 site in Costa Rica.
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 5 Jul 2023. 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 Costa Rica. 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?
Mortality (time frame: retrospective study (2020-2022)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05930574, which also lists 1 linked publication.
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 5 Jul 2023.