South African Surgical Outcomes Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,927
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
We will conduct a 7 day cohort study of consecutive patients aged 16 years and older undergoing inpatient noncardiac surgery. Patients will be followed up for a maximum of 30 days. We will follow the original European Surgical Outcomes Study (EuSOS) study design.
The primary outcome is in-hospital mortality. Secondary outcomes include length of stay and admission to intensive care. Centres across South Africa representing the public service will recruit patients. This study will run from 19 May 2014 to 26 May 2014.
详细描述
Methods -Seven day, South African national multi-centre cohort study of adult (≥16 years) patients undergoing in-patient non-cardiac surgery.
Centres
-We aim to recruit from as many South African centres as possible. Every Medical University in South Africa will participate in SASOS (University of Cape Town, University of the Free State, University of KwaZulu Natal, University of Limpopo, University of Pretoria, University of Stellenbosch, University of the Witwatersrand, and Walter Sisulu University), and most of the hospitals they support and serve will participate in this study.
Ethics approval
- Ethics approval has been obtained from each university centre.
- This study is in effect a large scale clinical audit, and as such a waiver of consent has been approved by seven of the eight medical school ethics committees, similar to the international precedent that was already set, as in the original EuSOS study, where consent was waived in 27 of the 28 European countries participating. Only the University of Witwatersrand requires patient consent for SASOS.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients admitted to participating centres undergoing elective and non-elective non-cardiac surgery commencing during the seven day study cohort period with a planned overnight stay. The recruitment week will run from 07h00 on 19 May 2014 to 06h59 on 26 May 2014.
排除标准
- •Patients undergoing planned day-case surgery, cardiac surgery or radiological procedures not requiring anaesthesia.
结局指标
主要结局
Mortality
时间窗: Upto 30 days
In hospital mortality
次要结局
- Duration of Hospital Stay(Upto 30 days)
- Admission to Critical Care After Surgery(Upto 30 days)
- Duration of Critical Care Stay(Upto 30 days)