I’m inviting pediatric surgeons, anesthesiologists, trainees, medical students, and nurses participating in surgical operations of congenital anomalies to participate in the Global PaedSurg-1 study.
The scope of the study
Congenital anomalies have risen to become the 5th leading cause of death in children under 5-years of age globally, yet limited literature exists, particularly from low- and middle-income countries (LMICs) where most of these deaths occur. The aim of this multi-center prospective cohort study is to compare outcomes of congenital anomalies between LMICs and high-income countries (HICs) globally.
Data will be collected on patients presenting primarily with seven congenital anomalies (oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation and Hirschsprung’s disease) for a minimum of one month between Oct 2018 – April 2019. Anonymous data will be collected on patient demographics, clinical status, interventions, and outcome. Data will be captured using the secure, online data collection tool REDCap.
The primary outcome will be all-cause in-hospital mortality and the secondary outcomes will be the occurrence of postoperative complications. The chi-squared analysis will be used to compare mortality between LMICs and HICs. Multilevel, multivariate logistic regression analysis will be undertaken to identify patient level and hospital level factors affecting outcomes with adjustment for confounding factors. P<0.05 will be deemed significant. Study approval will be sought from all participating centers. Funding has been granted by the Wellcome Trust.
The study aims to be the first large-scale, geographically comprehensive, multi-center prospective cohort study of a selection of common congenital anomalies to define current management and outcomes globally. Results will be used to aid advocacy and global health prioritization and inform future interventional studies aimed at improving outcomes.
Who can participate?
- Pediatric surgeons
- Medical students*
* Medical students cannot participate alone; For each center, at least one senior pediatric surgeon or anesthesiologist should register and participate in the study.
Eligible centers are hospitals where surgical management of congenital anomalies is performed. Any hospital anywhere in the world can participate in the study.
The study will be performed within the period from Oct 2018 to April 2019. Each team will be required to collect consecutive data for one month (+30 day-follow up for each patient).
Regional leads are investigators who are coordinating the study in multiple countries across the world. Regional leads of the African continent are:
- North African Countries: Dr. Ahmed Negida
- Egypt and the Middle East: Dr. Mahmoud Elfiky
- West Africa: Dr. Alliance Niyukuri
- COSECSA region: Prof. Milliard Derbew
Who is the Principal Investigator of this study?
Dr. Naomi Wright, Paediatric Surgery Registrar, and Ph.D. Fellow, King’s Centre for Global Health and Health Partnerships, King’s College London, UK.
How to register for this study?
Contact your country lead or regional lead to arrange for your data collection period and to process the required ethical approvals.