Latin American Surgical Outcomes Study in Pediatric Patients

NCT05934682 · tracked via the Priya Life Science Brazil tracker

Sponsor

University of Sao Paulo

Phase

Observational

Started

2023-12-20

Last updated

2024-12-09

Condition(s) studied

Postoperative ComplicationsChildrenNeonateInfantAnesthesia

Investigational drug(s) / intervention(s)

Surgery

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

Study summary

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

Sex

ALL

Min age

1 Day

Max age

18 Years

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: 1. 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); 2. patients undergoing obstetric surgery.

Primary outcome measure(s)

Postoperative in-hospital complication — until 30 days
Percentage of postoperative complications in-hospital

Trial sites (1)

Facility	City	Region	Status
Academic Reserach Organization, Instituto do Coracao, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo	São Paulo	São Paulo	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05934682 on ClinicalTrials.gov ↗ ← All trials in Brazil