Paediatric Surgery Across Sub-Saharan Africa: A Multi-Centre Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,407
- 试验地点
- 1
- 主要终点
- All-cause in-hospital mortality
研究概览
简要总结
Background: Five billion people worldwide do not have access to safe, affordable surgical care. A significant proportion live in sub-Saharan Africa (SSA), where up to 50% of the population are children. There is limited literature on neonatal and paediatric surgery in SSA and children's surgery does not appear on any of the National Health Strategic Plans for the 47 independent countries across SSA.
Objectives: To form a collaboration of surgeons and allied health professionals involved in children's surgery across SSA and collectively undertake the largest prospective cohort study of paediatric surgery in this region.
Materials and Methods: Data will be collected via REDCap website on all patients with gastroschisis, anorectal malformation, appendicitis, inguinal hernia and intussusception, during a 1-month period of collaborators choice between October 2016 to April 2017, with a 30-day follow up until the end of May 2017. Estimated study population: 1450 patients from 50 institutions. Full ethical approval has been granted by the host centre; local ethical approval will be required at collaborating centres for participation. All collaborators will be co-authors.
Primary outcome will be in-hospital all-cause mortality. Secondary outcomes will include post-intervention complications. Data will be collected on institutional facilities, patient demographics, duration from condition onset to presentation, peri-operative resuscitation, intervention and outcome.
Differences in outcomes between SSA and benchmark data from high-income countries will be calculated using chi-squared analysis. Multi-level multivariate logistic regression analysis will be used to identify interventions and peri-operative factors associated with improved outcomes; p<0.05 will be deemed significant.
Outcome: Results will be used to advocate for enhanced children's surgical services in SSA. We shall identify context-appropriate interventions associated with improved outcome. The collaboration will help to enhance research capacity in the region.
详细描述
Introduction
Research Collaboratives
PaedSurg Africa aims to recruit surgeons and allied health professionals undertaking neonatal and paediatric surgery (PS) across sub-Saharan Africa (SSA) - an area heavily neglected in global health prioritisation. Such research collaboratives are being increasingly utilised as a highly effective and efficient method of collecting large volume prospective data in a short period of time. A great recruitment incentive will be ethical group co-authorship of published results for all research collaborators.
Global Paediatric Surgery
In 2015, the Lancet Commission on Global Surgery (LCoGS) highlighted that 5 billion people worldwide do not have access to safe, affordable surgical care. The same year, the World Health Assembly (Resolution 68.15) incorporated emergency and essential surgery and anaesthesic care within 'Universal Health Coverage'. In concordance with this, plans have arisen to exponentially scale up access to surgical care in low- and middle-income countries (LMICs). Children's surgery has yet to be formally recognised within these plans despite children forming up to 50% of the population in LMICs.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients under 16-years of age presenting primarily with one of the five study conditions during the data collection period. This includes those managed conservatively without surgery or intervention and those offered palliative care, except patients with an inguinal hernia who must receive surgery to be included.
排除标准
- •Patients re-presenting with one of the five study conditions with a complication from a previous intervention or requiring further surgical intervention.
结局指标
主要结局
All-cause in-hospital mortality
时间窗: In-hospital (if in the patient is still in hospital at 30-days post-intervention, a 30-day mortality will be utilised)
次要结局
- 30-day mortality(30-days)
- Duration of hospital stay(Patients are followed up for a maximum of 30-days post-intervention)
- Surgical site infection(Within 30-days post-intervention)
- Full thickness wound dehiscence(Within 30-days post-intervention)
- Need for re-intervention(Within 30-days of the primary intervention)