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临床试验/NCT05934682
NCT05934682招募中不适用

Latin American Surgical Outcomes Study in Pediatric Patients

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Postoperative in-hospital complication

研究概览

简要总结

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.

详细描述

Background

Surgery is a cost-effective public health intervention. However, there are significant disparities in access to and in the safety of surgical and anesthesia services in low- and middle-income countries compared to high-income countries. (1) Additionally, there is a significant burden of surgical disease in the pediatric surgical population with a significant unmet need. (2,3) In Africa, children represent a significant proportion of the population, with approximately 50% of the population aged <19 years; moreover, this proportion is very similar in Latin America. (4) Postoperative complications are an important determinant of surgical morbidity and mortality. Limited data from Africa and Latin America suggest that risk factors, incidence, and outcomes associated with pediatric surgical complications differ in high-income countries. In the South African Pediatric Surgical Outcomes Study (SAPSOS), patients in this middle-income country (5) had twice the incidence of complications (6-8), and the types of complications differed from those in high-income countries, with a predominance of infectious complications. Furthermore, risk factors for complications (including ASA physical status, urgent surgery, surgery severity, and infectious indication for surgery) were different from those in high-income countries, wherein the risk factors include post-conceptual age, ASA physical status > 3, history of cardiovascular disease, and cardiovascular, neurological, or orthopedic surgical procedures. (9) Postoperative mortality was observed to be ten times higher in

South Africa than in a prospective study in high-income countries. (10) Furthermore, a prospective study of pediatric perioperative mortality in 24 Kenyan hospitals demonstrated a 7-day postoperative mortality of 1.7% (11), which is 17 times higher than that reported in high-income countries.

The African Surgical Outcomes Study (ASOS) described surgical outcomes in African adult patients. (12) Specifically, patients had a lower risk profile and fewer complications than those in high-income countries. However, postoperative mortality was twice the global average. A similar study is being performed in Latin America (LASOS), which also includes adults.

It is necessary to determine the importance of complications in pediatric surgical patients in Latin America, as well as the risk factors and types of complications that are experienced by these patients, due to the fact that data on this population are scarce. Consequently, we will be able to target appropriate interventions and funding to improve surgical outcomes for children in Latin America.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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);
  • patients undergoing obstetric surgery.

结局指标

主要结局

Postoperative in-hospital complication

时间窗: until 30 days

Percentage of postoperative complications in-hospital

次要结局

  • Surgical mortality(until 30 days)
  • Admission to critical care(until 30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria José Carvalho Carmona

Associate Professor

University of Sao Paulo

研究点 (1)

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