An African, International Multi-centre Fourteen-day Evaluation of Patient Care and Clinical Outcomes for Paediatric Patients Undergoing Surgery (ASOS-Paeds)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8,625
- 试验地点
- 2
- 主要终点
- Postoperative complications
研究概览
简要总结
Access to safe surgery is a basic human right. This is highlighted by the work of the Lancet Commission on Global Surgery. There is a large burden of surgical disease in the paediatric surgical population with a large unmet need. In Africa, children comprise a significant proportion of the population with approximately 50% of the population being ≤19 years old. Limited data from Africa suggests the risk factors for, incidence and outcomes associated with paediatric surgical complications differ from HICs.
The African Surgical Outcomes Study (ASOS) has described surgical outcomes in adult patients in Africa.
There is a need to determine the burden of the complications in paediatric surgical patients in Africa, and the risk factors for and the type of complications experienced. Once this study is completed, the investigators will be able to target appropriate interventions to improve surgical outcomes for children in Africa. The investigators have the capacity to do this important work, through the African Perioperative Research Group (APORG) group.
详细描述
Surgery is a cost-effective public health intervention. There are significant disparities in access to and the safety of surgical and anaesthesia services in low and middle-income countries (LMICs) compared to high-income countries (HICs). There is a large burden of surgical disease in the paediatric surgical population with a large unmet need. In Africa, children comprise a significant proportion of the population with approximately 50% of the population being ≤19 years old.
Postoperative complications are an important determinant of surgical morbidity and mortality. Limited data from Africa suggests the risk factors for, incidence and outcomes associated with paediatric surgical complications differ from HICs. In the prospective, observational South African Paediatric Surgical Outcomes Study (SAPSOS), the patients in this middle-income country (MIC), had double the incidence of complications, and the types of complications differed from HICs, with a predominance of infective complications. Furthermore, the risk factors for complications (ASA physical status, urgency of surgery, severity of surgery and infective indication for surgery) were different from HICs, where risk factors include gestational age, ASA physical status >3, a history of cardiovascular disease, and cardiovascular, neurological, or orthopaedic surgical procedures. Postoperative mortality was ten times higher in South Africa than in a prospective study in HICs. A prospective study of paediatric perioperative mortality in 24 Kenyan hospitals showed a 7 day postoperative mortality of 1.7%, which is 17 times higher than that reported in HICs.
The African Surgical Outcomes Study (ASOS) has described surgical outcomes in adult patients in Africa. Patients had a lower risk profile and fewer complications compared to those in HICs. However, the postoperative mortality was twice that of the global average.
There is a need to determine the burden of the complications in paediatric surgical patients in Africa, and the risk factors for and the type of complications experienced. Once this study is completed, the investigators will be able to target appropriate interventions to improve surgical outcomes for children in Africa. The investigators have the capacity to do this important work, through the African Perioperative Research Group (APORG) group.
STUDY OBJECTIVE To determine the incidence of in-hospital postoperative complications up to 30 days post-surgery in paediatric surgical patients <18 years in Africa
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients < 18 years, admitted to participating hospitals during the study period
- •elective and non-elective surgery (including day case surgery)
- •operative procedures outside operating theatres where a general anaesthetic (GA) is performed.
排除标准
- •radiological or other procedures not requiring general anaesthesia, or where general anaesthesia is performed but no procedure is performed e.g. general anaesthesia during magnetic resonance imaging (MRI).
- •Obstetric surgery.
- •Prior participation in ASOS-Paeds.
结局指标
主要结局
Postoperative complications
时间窗: Until hospital discharge censored at 30 days postoperative
Incidence of in-hospital postoperative complications in paediatric surgical patients in Africa.
次要结局
- Access to surgery(Until hospital discharge censored at 30 days postoperative)
- Intraoperative critical incidents(Until hospital discharge censored at 30 days postoperative)
- Rate of admission to critical care(Until hospital discharge censored at 30 days postoperative)
- Postoperative mortality(Until hospital discharge censored at 30 days postoperative)
- Anesthesia and surgery providers(Until hospital discharge censored at 30 days postoperative)
- Number of specialists per paediatric population(Within 6 months of the start of recruitment)
研究者
Alexandra Torborg
Principal Investigator
University of KwaZulu