Health TrialsbyHealthPanel

Latin American Surgical Outcomes Study in Pediatric Patients

ConditionsPostoperative ComplicationsChildrenNeonateInfantAnesthesia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorUniversity of Sao Paulo

About this trial

This prospective, international, multicenter observational study will include hospitals performing pediatric surgery in participating Latin American countries.

We aim to assess the incidence of hospital postoperative complications in pediatric surgical patients \< 18-years-old in Latin America. We will recruit all consecutive pediatric patients under the age of 18 years who were admitted to participating hospitals undergoing elective and nonelective surgery. The primary outcome is in-hospital postoperative complications up to 30 days after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All of the consecutive patients under 18-years-old who were admitted to participating hospitals during the study period and who underwent elective and nonelective surgeries will be included in the study.

Disqualifiers

patients undergoing radiological or other procedures that do not require general anesthesia or in which general anesthesia is performed but no procedure is performed (e.g., general anesthesia during MRI);

patients undergoing obstetric surgery.

Trial population

Children submitted to surgery (elective and non-elective).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Surgery

    Procedure/Surgery

    All children submitted to surgery will be followed until hospital discharge or 30 days postoperatively.

Treatment groups

10,000 Participants
are divided into 1 treatment group
Group A: Children submitted to surgery1 intervention

Trial outcomes

Primary outcomes

1

Postoperative in-hospital complication

Percentage of postoperative complications in-hospital

Time frame
until 30 days

Secondary outcomes

1

Surgical mortality

Percentage of surgical mortality in-hospital

Time frame
until 30 days
2

Admission to critical care

Percentage of children admitted in critical care

Time frame
until 30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo

Lead sponsor

Source ClinicalTrials.gov
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