Observational study on postoperative complications in pediatric surgery in Latin America
Latin American Surgical Outcomes Study in Pediatric Patients
This study looks at the complications that can happen after surgery in kids under 18 in Latin America to see how common they are and what might cause them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT05934682 on ClinicalTrials.gov |
What this trial studies
This international, multicenter observational study aims to assess the incidence of postoperative complications in pediatric surgical patients under 18 years old across various hospitals in Latin America. It will include all consecutive patients admitted for elective and nonelective surgeries, tracking complications that arise within 30 days post-surgery. The study seeks to identify risk factors and outcomes associated with these complications, which may differ significantly from those observed in high-income countries. By gathering this data, the study aims to address disparities in surgical care and improve patient safety in the region.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients under 18 years old undergoing elective or nonelective surgeries in participating Latin American hospitals.
Not a fit: Patients undergoing radiological procedures or obstetric surgeries will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of postoperative complications in pediatric patients, ultimately enhancing surgical outcomes.
How similar studies have performed: While there have been studies on pediatric surgical outcomes in other regions, this specific focus on Latin America is novel and aims to fill a significant gap in existing data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
São Paulo, São Paulo
- Academic Reserach Organization, Instituto do Coracao, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Vinicius Quintao, MD, PhD — Postdoctoral fellow
- Study coordinator: Vinicius Quintao, MD, PhD
- Email: vinicius.quintao@hc.fm.usp.br
- Phone: + 55 11 2661-5795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.