African Surgical Outcomes Study (ASOS): An African, Multi-centre Seven Day Evaluation of Patient Care and Clinical Outcomes for Patients Undergoing Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11,422
- 试验地点
- 2
- 主要终点
- Incidence of in-hospital postoperative complications in adult surgical patients in Africa
研究概览
简要总结
STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa.
STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study design.
The primary outcome is in-hospital postoperative complications in adult surgical patients in Africa. Secondary outcomes include in-hospital mortality and the relationship between postoperative complications and postoperative mortality.
The intention is to present a representative sample of surgical outcomes across all African countries. This study will run between February and March 2016.
详细描述
Research questions
Primary objective To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa Secondary objectives
- To confirm the rate of mortality on the day of surgery for patients undergoing surgery in Africa.
- To confirm the in-hospital mortality rate for patients undergoing surgery in Africa.
- To describe the relationship between postoperative complications and postoperative mortality.
- To describe the proportional contribution of communicable, non-communicable diseases and traumatic injuries to in-hospital mortality and critical care admissions in Africa.
Methods Seven day, African national multi-centre cohort study of adult (≥18 years) patients undergoing surgery. This study will be registered on ClinicalTrials.gov.
Inclusion criteria All consecutive patients admitted to participating centres undergoing elective and non-elective surgery commencing during a seven day study cohort period with a planned overnight hospital stay following surgery. The recruitment week will run between February and March 2016.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All consecutive patients admitted to participating centres undergoing elective and non-elective surgery commencing during a seven day study cohort period with a planned overnight hospital stay following surgery. The recruitment week will run between February and May 2016.
排除标准
- •Patients undergoing planned day-case surgery or radiological procedures not requiring anaesthesia.
结局指标
主要结局
Incidence of in-hospital postoperative complications in adult surgical patients in Africa
时间窗: In-hospital upto 30 days
Postoperative complications
次要结局
- Rate of mortality on the day of surgery for patients undergoing surgery in Africa(1 day)
- The in-hospital mortality rate for patients undergoing surgery in Africa(In-hospital upto 30 days)