Perioperative and anaesthetic-related mortality in developed and developing countries: a systematic review and meta-analysis.
Daniel Bainbridge, Janet Martin, Miguel Arango...
https://pubmed.ncbi.nlm.nih.gov/22998717Actively Recruiting
Age: 1Day - 18Years
All Genders
ID05934682
Latin American Surgical Outcomes Study in Pediatric Patients
Led by University of Sao Paulo · Updated on 2024-12-09
10000
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an international, multicenter observational study to evaluate postoperative complications in pediatric patients under 18 years old undergoing surgery in Latin American hospitals. The study aims to understand the incidence and types of in-hospital complications up to 30 days after surgery, as well as related mortality and risk factors specific to this population. This research addresses gaps in data about surgical outcomes in low- and middle-income countries and seeks to improve care for children in Latin America. The study will include all consecutive pediatric patients admitted for elective or nonelective surgeries during a 14-day recruitment period at participating hospitals. Surgeries performed outside operating rooms with local or general anesthesia are also included, but radiological procedures without surgery and obstetric surgeries are excluded. Each child will be followed from surgery until hospital discharge or 30 days postoperatively to monitor outcomes. Participants will have their data collected via secure electronic or paper forms, recording demographic, surgical, and outcome information. Researchers will analyze postoperative complications, mortality, severe intraoperative events, and intensive care admissions. Data will be anonymized and securely stored. This observational study does not involve treatment but focuses on monitoring and understanding surgical outcomes over the study period.
CONDITIONS
Brief Title
Latin American Surgical Outcomes Study in Pediatric Patients
Who Can Participate
Age: 1Day - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients under 18 years old admitted to participating hospitals
- Undergoing elective or nonelective surgery during the study period
- Includes surgeries performed outside operating rooms requiring local or general anesthesia
- Includes outpatient surgeries
You will not qualify if you...
- Patients undergoing radiological or other procedures not requiring surgery or where general anesthesia is given but no procedure is performed
- Patients undergoing obstetric surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Surgery and Immediate Post-operative Care
Duration - Up to hospital discharge or 30 days after surgery
Participants undergo surgery and are monitored during their hospital stay for immediate postoperative care.
1 hospital stay with continuous monitoring
Post-operative Follow-up
Duration - Up to 30 days after surgery
Participants are observed for postoperative complications and mortality for up to 30 days after surgery.
Follow-up assessments during hospital stay and up to 30 days post-surgery
Trial Site Locations
Total: 1 location
1
Academic Reserach Organization, Instituto do Coracao, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo
São Paulo, São Paulo, Brazil, 05403-000
Actively Recruiting
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Research Team
V
Vinicius Quintao, MD, PhD
A
Alexandra Vieira, Pharm, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Surgical services for children in developing countries.
S W Bickler, H Rode
https://pubmed.ncbi.nlm.nih.gov/12471405Epidemiology of pediatric surgical needs in low-income countries.
Elissa K Butler, Tu M Tran, Neeraja Nagarajan...
https://pubmed.ncbi.nlm.nih.gov/28257418South African Paediatric Surgical Outcomes Study: a 14-day prospective, observational cohort study of paediatric surgical patients.
A Torborg, L Cronje, J Thomas...
https://pubmed.ncbi.nlm.nih.gov/30686308Determinants of morbidity and mortality following emergency abdominal surgery in children in low-income and middle-income countries.
GlobalSurg Collaborative
https://pubmed.ncbi.nlm.nih.gov/28588977Incidence of severe critical events in paediatric anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe.
Walid Habre, Nicola Disma, Katalin Virag...
https://pubmed.ncbi.nlm.nih.gov/28363725Latin American Surgical Outcomes Study in Paediatrics (LASOS-Peds): study protocol and statistical analysis plan for a multicentre international observational cohort study.
Vinícius Caldeira Quintão, Gabriel Soares de Sousa, Alexandra Torborg...
https://pubmed.ncbi.nlm.nih.gov/39313281