This study will involve a 14-day Latin American international multicenter prospective cohort study of pediatric patients (<18 years) undergoing surgery.
Patients will be followed up until hospital discharge. This will be censored in thirty days; specifically, patients will be followed up until discharge or for thirty days after surgery if they are still in the hospital.
The primary objective of LASOS-Peds is to determine the incidence of in-hospital postoperative complications up to 30 days after surgery in Latin American pediatric surgical patients (under 18-years old).
Research ethics and regulatory approvals will be sought before the initiation of the study in each location by using national research legislation/guidelines for that country. National leaders will ensure that the necessary ethical and regulatory approvals are obtained for participating hospitals in their country. Hospitals can only record data if there is ethical approval or an equivalent waiver.
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. This analysis will include outpatient surgeries and surgical procedures outside of operating rooms requiring local or general anesthesia. Recruitment will occur for fourteen days, starting on the date chosen by each participating hospital within the study cohort period (to be determined).
We expect that all consecutive pediatric patients under 18 years undergoing elective and nonelective surgeries will be included in the study. Each hospital must record and submit a triage record of all of the eligible patients. Publicity through the appropriate hospital notices and signage will inform patients, their parents/guardians, and the public that the hospital is participating in the study.
Each hospital will individually collect and record data on an electronic or paper case recording form (CRF) for each recruited patient. Paper CRFs will be stored in a locked office at each hospital, as they will include patient-identifiable data to allow for the tracking of clinical outcomes.
Data will be pseudoanonymized by generating a unique numeric code and transcribed by local investigators into a secure, password-protected electronic CRF on the REDCap platform.
Access to the data entry system will be protected by the username and password provided during the registration process to individual local investigators. All of the electronic data transfers between participating hospitals and the coordinating center will be encrypted by using a secure protocol (HTTPS/SSL 3.0 or higher).
Each hospital will maintain a secure trial file, including a protocol, local investigator delegation record, ethics approval documentation, participant list, and other documentation (such as trial definitions).
LASOS-Peds is an investigator-initiated study, supported by a grant from Smile Train.
https://www.clinicaltrials.gov/
Clinical Trial Registration: NCT05934682
