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Recruiting NCT05934682

Latin American Surgical Outcomes Study in Pediatric Patients

◆ AI Clinical Summary

This study looks at what complications can happen after surgery in children under 18 years old across Latin America. Researchers will collect information from hospitals to understand how often these complications occur and what factors might affect them.

Key Objective: The study aims to identify patterns in post-surgery complications in children to help improve surgical safety and care practices across Latin American hospitals.

Who to Consider: Children under 18 years old who are undergoing surgery at participating hospitals in Latin America should consider enrolling.

Trial Parameters

Condition Postoperative Complications
Sponsor University of Sao Paulo
Study Type OBSERVATIONAL
Phase N/A
Enrollment 10,000
Sex ALL
Min Age 1 Day
Max Age 18 Years
Start Date 2023-12-20
Completion 2025-02-28
Interventions
Surgery

Brief 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 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.

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