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临床试验/NCT03367832
NCT03367832已完成不适用

South African Paediatric Surgical Outcomes Study (SAPSOS) A South African National, Multi-centre Fourteen Day Evaluation of Patient Care and Clinical Outcomes for Paediatric Patients Undergoing Surgery

University of KwaZulu1 个研究点 分布在 1 个国家目标入组 2,025 人开始时间: 2017年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,025
试验地点
1
主要终点
Postoperative complications

研究概览

简要总结

There are few data of paediatric peri-operative morbidity and mortality in South Africa. There is little information on the burden or profile of surgical disease in the paediatric population, the level of anaesthesia or surgical care (specialist versus non-specialist) for paediatric patients, the quality of peri-operative care or contributing factors to poor outcomes. In order to understand current paediatric peri-operative morbidity and mortality in South Africa, it is important to start obtaining these data. Risk factors can be identified and changes can be in implemented accordingly to improve future outcomes.

The study will take place over fourteen-days. It is a South African national multi-centre prospective cohort study of paediatric patients (<16 years) undergoing surgery. The SAPSOS study (as was the South African Surgical Outcomes Study (SASOS) study) will be based on the methodology of the European Surgical Outcomes Study (EuSOS).

This study has important public health implications for South Africa as surgery is now recognized internationally as an essential part of public health, yet still needs to be defined as a priority in South Africa. Policy-makers and healthcare providers need evidence to plan resource allocation in a way that will improve quality and outcomes. The data from SAPSOS and SASOS, would provide a platform for government and health care providers in South Africa to appropriately allocate funding, make policy decisions and plan future peri-operative healthcare in South Africa.

详细描述

Methods

Fourteen-day, South African national multi-centre prospective cohort study of paediatric patients (<16 years) undergoing surgery.

Centres

The investigators aim to recruit from as many South African centres as possible. The investigators anticipate that every Medical University in South Africa will participate (University of Cape Town, University of the Free State, University of KwaZulu-Natal, University of Limpopo, University of Pretoria, University of Stellenbosch, Sefako Makgatho Health Sciences University, University of the Witwatersrand, and Walter Sisulu University), and most of the hospitals they support and serve will participate in this study.

Ethics approval

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 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All consecutive patients < 16 years, admitted to participating centres during the study period who undergo elective and non-elective surgery. This will include day case surgery and operative procedures outside operating theatres where a general anaesthetic (GA) is performed. -

排除标准

  • Patients undergoing radiological or other procedures not requiring general anaesthesia, or where general anaesthesia is performed but no procedure is done e.g. GA during a magnetic resonance imaging (MRI).
  • Obstetric surgical procedures. -

结局指标

主要结局

Postoperative complications

时间窗: 30 days

In-hospital postoperative complications in paediatric surgical patients in South Africa

次要结局

  • Mortality(24 hours)
  • Critical Care(30 days)
  • In-hospital Mortality(30 days)

研究者

发起方
University of KwaZulu
申办方类型
Other
责任方
Sponsor

研究点 (1)

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