AIMS:Simulation training enhances efficacy and safety of preformed silo deployment in gastroschisis. Limitations of existing simulation models include use of biological material, low fidelity, poor durability, and high cost. We developed a novel gastroschisis simulation model and report its validation and performance in a multicentre interventional study. METHOD:Paediatric surgeons collaborated with a medical-model specialist to develop a novel GAstroschisis BaBY (GABBY)-T model. This was validated against two existing simulation models by 15 paediatric surgeons using a Likert scale (1-10) to compare each model (A,B,C) to real-life application, including tactile feedback, realism, and usefulness. Data are presented as median (range). Sixteen GABBY-T models were used to teach preformed silo use as part of a Gastroschisis Interventional Study in 37 hospitals across sub-Saharan Africa. Durability of the models was recorded. RESULTS:GABBY-T model features non-biological silicone bowel, improved fidelity, and ability to simulate all aspects of preformed silo use for gastroschisis care, at $390/model. Usefulness, realism, tactile feedback (p < 0.01) and overall experience (p < 0.05) were all rated significantly higher in the new model compared to the other models (A = 9, 8, 8, 9), (B = 6, 5, 6.5, 5), (C = 6, 5.5, 5, 6), respectively. 33 % of surgeon participants would recommend older models while 100 % recommended the new model for training. During the Gastroschisis Interventional Study, each model was used >100 times. 5/16 models sustained minor bowel tears without affecting performance. Four models suffered damage requiring replacement components. CONCLUSIONS:The GABBY-T model for preformed silo application simulation outperforms previous models. GABBY-T model has high fidelity and durability at moderate cost, facilitating training of large numbers of healthcare providers.

BACKGROUND:Gastroschisis is a congenital anomaly with >90 % survival in high-income countries. Despite advances in neonatal care, survival remains below 20 % in much of sub-Saharan Africa. We evaluate temporal changes in mortality and current predictors of mortality after implementing a standardized care bundle at a tertiary facility in Malawi. METHODS:A retrospective, cross-sectional study included neonates admitted to Kamuzu Central Hospital between 7/1/2023 and 6/3/2024 with gastroschisis. In-hospital mortality was compared between this and a historical cohort (10/21/2019-11/30/2020). Both cohorts were treated under the same care bundle, which was newly implemented in 2019. Time-to-death analysis and logistic regression were used to understand predictors associated with contemporary in-hospital mortality. RESULTS:The 2023-2024 cohort included 99 neonates, with a mean birth weight of 2.21 kg and a median gestational age of 36 weeks. Mortality decreased significantly to 71.7 % from 90.9 % in the 2019-2020 cohort (p = 0.005). 85.9 % of deaths occurred in the first 10 days of life. Bivariate analysis showed mortality was associated with female sex (p = 0.048), low birth weight (p = 0.002), and short length of stay (p < 0.001). Logistic regression identified birthweight <2 kg as a significant predictor of mortality (OR = 4.59, p = 0.03). CONCLUSION:Mortality from gastroschisis has decreased over time following the implementation of a care bundle, with most deaths occurring in the first 10 days of life. The most significant predictor of mortality in the contemporary cohort was birthweight under 2 kg. These data may inform future targeted interventions to further decrease gastroschisis mortality.

Background: This study assessed the potential cost-effectiveness of high (80–100%) vs low (21–35%) fraction of inspired oxygen (FiO2) at preventing surgical site infections (SSIs) after abdominal surgery in Nigeria, India, and South Africa. Methods: Decision-analytic models were constructed using best available evidence sourced from unbundled data of an ongoing pilot trial assessing the effectiveness of high FiO2, published literature, and a cost survey in Nigeria, India, and South Africa. Effectiveness was measured as percentage of SSIs at 30 days after surgery, a healthcare perspective was adopted, and costs were reported in US dollars ($). Results: High FiO2 may be cost-effective (cheaper and effective). In Nigeria, the average cost for high FiO2 was $216 compared with $222 for low FiO2 leading to a −$6 (95% confidence interval [CI]: −$13 to −$1) difference in costs. In India, the average cost for high FiO2 was $184 compared with $195 for low FiO2 leading to a −$11 (95% CI: −$15 to −$6) difference in costs. In South Africa, the average cost for high FiO2 was $1164 compared with $1257 for low FiO2 leading to a −$93 (95% CI: −$132 to −$65) difference in costs. The high FiO2 arm had few SSIs, 7.33% compared with 8.38% for low FiO2, leading to a −1.05 (95% CI: −1.14 to −0.90) percentage point reduction in SSIs. Conclusion: High FiO2 could be cost-effective at preventing SSIs in the three countries but further data from large clinical trials are required to confirm this.

Background Sub-Saharan Africa experiences a disproportionate amount of pediatric surgical disease, with 80% of children lacking access to timely, affordable, and safe surgical care. This study aims to characterize the burden of disease and outcomes of pediatric surgical conditions at Connaught Hospital, the main pediatric referral hospital in Sierra Leone.Methods This retrospective and hospital-based study included children up to 15 years old who were operated on between 2015 and June 2016 at Connaught Hospital in Freetown, Sierra Leone. Descriptive and inferential statistics were used to characterize the distribution of disease and compare all variables against age category and mortality.Findings A total of 215 patients were included in this study of which 72.5% (n=132) were male and 27.5% (n=50) were female. Most of the patients were diagnosed with congenital anomalies (60.9%; n=131). However, infection was the leading diagnosis (60.5%; n=23) among patients aged 5–10 years (n=38). Inguinal hernia was the leading condition (65.0%; n=85) among patients presenting with a congenital anomaly. The condition with the highest mortality was infections (17.0%; n=8), followed by other conditions (9.1%; n=2) and congenital anomalies (3.1%; n=4). Based on the results of this study, over 7000 children with inguinal hernias remain untreated annually in Freetown, Sierra Leone.Conclusion This study quantifies the burden of surgical disease among children, a foundational step toward the prioritization of pediatric surgical care in national health agendas, the development of evidence-based interventions, and the strategic allocation of resources in Sierra Leone.

Appendix S1. Global survey on fetal ultrasound anomaly screening by GICS Appendix S2. Results from the survey Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

This research adopted a care protocol from high-income countries in a level II/III hospital in a middle-income country to decrease morbidity and mortality associated with gastroschisis. We established a multidisciplinary protocol to treat patients with gastroschisis prospectively from November 2012 to November 2018. This included prenatal diagnosis, presence of a neonatologist and pediatric surgeon at birth, and either performing primary closure on the patients with an Apgar score of 8/9, mild serositis, and no breathing difficulty or placing a preformed silo, when unable to fulfill these criteria, under sedation and analgesia (no intubation) in the operating room or at the patients’ bedside. The subsequent management took place in the neonatal intensive care unit. The data were analyzed through the Mann–Whitney and Student’s t-distribution for the two independent samples; the categorical variables were analyzed through a chi-square distribution or Fisher’s exact test. In total, 55 patients were included in the study: 33 patients (60%) were managed with a preformed silo, whereas 22 patients (40%) underwent primary closure. Prenatal diagnosis (P = 0.02), birth at the main hospital (P = 0.02), and the presence of a pediatric surgeon at birth (P = 0.04) were associated with successful primary closure. The primary closure group had fewer fasting days (P < 0.001) and a shorter neonatal intensive care unit length of stay (P = 0.025). The survival rate was 92.7% (51 patients). The treatment model modified to fit the means of our hospital proved successful.

Background The 2015 lancet Commission on global surgery identified surgery and anaesthesia as indispensable parts of holistic health-care systems. However, COVID-19 exposed the fragility of planned surgical services around the world, which have also been neglected in pandemic recovery planning. This study aimed to develop and validate a novel index to support local elective surgical system strengthening and address growing backlogs. Methods First, we performed an international consultation through a four-stage consensus process to develop a multidomain index for hospital-level assessment (surgical preparedness index; SPI). Second, we measured surgical preparedness across a global network of hospitals in high-income countries (HICs), middle-income countries (MICs), and low-income countries (LICs) to explore the distribution of the SPI at national, subnational, and hospital levels. Finally, using COVID-19 as an example of an external system shock, we compared hospitals' SPI to their planned surgical volume ratio (SVR; ie, operations for which the decision for surgery was made before hospital admission), calculated as the ratio of the observed surgical volume over a 1-month assessment period between June 6 and Aug 5,2021, against the expected surgical volume based on hospital administrative data from the same period in 2019 (ie, a pre-pandemic baseline). A linear mixed-effects regression model was used to determine the effect of increasing SPI score. Findings In the first phase, from a longlist of 103 candidate indicators, 23 were prioritised as core indicators of elective surgical system preparedness by 69 dinicians (23133%) women; 46 [67%] men; 41 from HICs, 22 from MICs, and six from LICs) from 32 countries. The multidomain SPI included 11 indicators on facilities and consumables, two on staffing, two on prioritisation, and eight on systems. Hospitals were scored from 23 (least prepared) to 115 points (most prepared). In the second phase, surgical preparedness was measured in 1632 hospitals by 4714 clinicians from 119 countries. 745 (45.6%) of 1632 hospitals were in MICs or LICs. The mean SPI score was 84.5 (95% CI 84.1-84.9), which varied between HIC (88.5 189.0-88.0]), MIC (81.8 [82.5-81.1]), and LIC (66.8 [64.9-68.7]) settings. In the third phase, 1217 (74.6%) hospitals did not maintain their expected SVR during the COVID-19 pandemic, of which 625 (51.4%) were from HIC, 538 (44.2%) from MIC, and 54 (4.4%) from LIC settings. In the mixed-effects model, a 10-point increase in SPI corresponded to a 3.6% (95% CI 3.0-4.1; p<0.0001) increase in SVR. This was consistent in HIC (4.8% [4.1-5.5]; p<0.0001), MIC (2.8 [2.0-3.7]; p<0.0001), and LIC (3.8 [1.3-6 . 7%]; p<0.0001) settings. Interpretation The SPI contains 23 indicators that are globally applicable, relevant across different system stressors, vary at a subnational level, and are collectable by front-line teams. In the case study of COVID-19, a higher SPI was associated with an increased planned surgical volume ratio independent of country income status, COVID-19 burden, and hospital type. Hospitals should perform annual self-assessment of their surgical preparedness to identify areas that can be improved, create resilience in local surgical systems, and upscale capacity to address elective surgery backlogs. Copyright (C) 2022 The Author(s). Published by Elsevier Ltd.

Introduction As childhood mortality from infectious diseases falls across sub-Saharan Africa (SSA), the burden of disease attributed to surgical conditions is increasing. However, limited data exist on paediatric surgical outcomes in SSA. We compared the outcomes of five common paediatric surgical conditions in SSA with published benchmark data from high-income countries (HICs). Methods A multicentre, international, prospective cohort study was undertaken in hospitals providing paediatric surgical care across SSA. Data were collected on consecutive children (birth to 16 years), presenting with gastroschisis, anorectal malformation, intussusception, appendicitis or inguinal hernia, over a minimum of 1 month, between October 2016 and April 2017. Participating hospitals completed a survey on their resources available for paediatric surgery. The primary outcome was all-cause in-hospital mortality. Mortality in SSA was compared with published benchmark mortality in HICs using chi(2) analysis. Generalised linear mixed models were used to identify patient-level and hospital-level factors affecting mortality. A pResults 1407 children from 51 hospitals in 19 countries across SSA were studied: 111 with gastroschisis, 188 anorectal malformation, 225 intussusception, 250 appendicitis and 633 inguinal hernia. Mortality was significantly higher in SSA compared with HICs for all conditions: gastroschisis (75.5% vs 2.0%), anorectal malformation (11.2% vs 2.9%), intussusception (9.4% vs 0.2%), appendicitis (0.4% vs 0.0%) and inguinal hernia (0.2% vs 0.0%), respectively. Mortality was 41.9% (112/267) among neonates, 5.0% (20/403) in infants and 1.0% (7/720) in children. Paediatric surgical condition, higher American Society of Anesthesiologists score at primary intervention, and needing/receiving a blood transfusion were significantly associated with mortality on multivariable analysis. Conclusion Mortality from common paediatric surgical conditions is unacceptably high in SSA compared with HICs, particularly for neonates. Interventions to reduce mortality should focus on improving resuscitation and timely transfer at the district level, and preoperative resuscitation and perioperative care at paediatric surgical centres.

Purpose To describe the epidemiology and referral patterns of gastroschisis patients in northern Ghana. Methods A hospital-based retrospective review was undertaken at Tamale Teaching Hospital (TTH) Neonatal Intensive Care Unit (NICU) between 2014 and 2019. Data from gastroschisis patients were compared to patients with other surgical diagnoses. Descriptive and inferential statistics were performed with SAS. Referral flow maps were made with ArcGIS. Results From a total of 360 neonates admitted with surgical conditions, 12 (3%) were diagnosed with gastroschisis. Around 91% (n = 10) of gastroschisis patients were referred from other hospitals, traveling 4 h, on average. Referral patterns showed gastroschisis patients were admitted from three regions, whereas patients with other surgical diagnoses were admitted from eight regions. Only 6% (12/201) of expected gastroschisis cases were reported during the 6-year period in all regions. All gastroschisis deaths occurred within the first week of life. Conclusions Improving access to surgical care and reducing neonatal mortality related to gastroschisis in northern Ghana is critical. This study provides a baseline to inform future gastroschisis interventions at TTH. Priority areas may include special management of low birth weight newborns, better referral systems, empowerment of community health workers, and increasing access to timely, affordable, and safe neonatal transport.

The COVID-19 pandemic has had profound impacts on safe healthcare delivery, particularly within surgical specialties. There has been clear evidence of pulmonary complications and death associated with surgery following perioperative COVID infection. Mitigation of COVID-related risk for patients depends upon several primary tenets of safe surgery, including implementation of appropriate COVID-secure treatment pathways, provision of adequate testing for patients to ensure COVID-negative status and protection of staff members through suitable personal protective equipment (PPE). Following the initial peaks of SARSCoV-2 infection, healthcare service provision was afforded time for preparation and reorganization before subsequent waves of infection. An ability to use this window of opportunity was dependent not only on strategic decision making but also national financial resources and healthcare capabilities. Vaccines against the SARS-CoV-2 virus have demonstrated efficacy, however timely accessibility for healthcare workers, let alone the global population, remains inequitable. The prioritization of healthcare workers alongside surgical patients is essential to impact perioperative mortality. Despite international roll-outs of vaccination, repeated waves of COVID-19 infection are apparent across all continents. Utilizing an international survey of practice, distributed through an existing COVIDSurg head and neck (HN) collaborative, social media and international HN clinical networks, the authors sought to assess the extent to which COVID-safe HN cancer surgery and individual surgeon-specific protection were implemented between the initial stages of the pandemic (March– June 2020) and a subsequent period in February 2021 after well documented increases in COVID-19 incidence globally and an evolving, evidence-based understanding of the disease (Supplementary material). Analysis of 213 responses from HN institutions situated in 39 countries (Table S1), demonstrated a clear disparity in the implementation of patient and staff COVID testing, in PPE usage, and in surgeon-level vaccination when classified by national wealth (World Bank national income classification) (Table 1). Despite evidence of consistent international improvements since the early stages of the pandemic, by February 2021, centres in lowand low–middle-income countries were still significantly less likely to employ routine preoperative COVID testing (60 per cent) or PPE use (49 per cent) compared with global averages (89 and 62 per cent respectively). Further evidence of significant global inequality was apparent in disparate vaccination access: less than one third of surgical staff in lowand low–middle-income countries received a first vaccine dose by spring 2021 (international average 68.4 (95 per cent c.i. 63.2 to 73.6) per cent). HN centres in countries experiencing highest levels of population COVID incidence (25 or more per 100 000 population) in spring 2021 correlated to highest levels of testing, PPE use and vaccination (Table S2). However, there was an international trend towards reduction in PPE use over time, particularly pronounced in UK centres, and within hospitals designated as cold sites (Table S3). Although ongoing fluctuations in PPE availability may have influenced this pattern, growing ambivalence or over-reliance on testing and/or vaccination may also have contributed, such that the role of PPE in HN surgery is deemed less relevant by surgeons. Reported COVID-19 infections amongst surgeons (16 per cent) within this survey are at least double those of conservative contemporaneous population-level estimates. In countries yet to receive nationwide vaccination, HN surgeons had even higher levels of prior COVID infection (26 per cent), highlighting further global wealth inequalities and populations with potentially greater latent need. Whilst the authors recognize inherent limitations to these data, including the intrinsic bias associated with surveys, it is evident that global wealth inequality appears to drive disparities in access to critical elements of appropriate healthcare, risking both patient and staff safety. HN surgery exemplifies many of the highest risks of surgery in general and remains critically reliant on COVID-secure pathways supported by robust testing, adequate PPE provision and vaccination. These data share yet another indicator of inequitable distribution of healthcare resource at a time when we are all reliant upon worldwide solutions.

It is estimated that 28-32% of the global burden of disease can be treated with surgery. Most of this burden is concentrated in low and middle-income countries, underpinning the importance of the topic of global surgery (GS). The multidisciplinary principles of GS are increasingly recognised as being key to modern practice and as such, must be fostered at early stages of medical training. However, it is unclear whether medical students are being exposed to GS. This study aimed to assess the importance of GS and its presence in medical curricula.A novel, 22-item online questionnaire was developed and disseminated to medical students and faculty members using social media platforms. Data collection was conducted by a collaboration of medical students, who acted as regional leads at their institutions.795 medical students and 141 faculty members representing 38/42 (90.4%) of UK medical schools completed the questionnaire. Only 84 students (10.6%) were previously exposed to GS. Most students (66.3%) and faculty (60.6%) agreed that GS should be an integral part of the curriculum. Only 20 students (2.5%) were familiar with what a career in GS means.Approximately two-third of students and faculty agree that global surgery should be an integral part of the mandatory curriculum. Findings of this study should underpin further incorporation of GS into curricula, as high-income countries can decisively contribute to achieving the global surgery 2030 targets, by training a new generation of clinicians who are ready for the challenges of the 21st century.

Background: In 2011 a consensus statement from the British Association of Paediatric Urologists recommended lowering the age at orchidopexy to under 1 year. There are concerns that a younger age at operation may increase postoperative testicular atrophy. The ORCHESTRA study aimed to establish the current age at orchidopexy in a multicentre, international audit and to see whether testicular atrophy was affected by age at operation. Methods: The study was undertaken over a 3-month period in 28 centres in boys undergoing orchidopexy for unilateral, palpable undescended testes. Data collection was done using a standardized, predetermined protocol. The primary outcome was postoperative testicular atrophy. Secondary outcomes were wound infections, reoperations, and unplanned hospital stays related to anaesthetic events. Results: A total of 417 patients were included, of whom only 48 (11.5 per cent) underwent orchidopexy before 1 year of age. There was no difference in anaesthetic complications in boys aged less than 1 year versus older patients: 0 of 48 (0 per cent) versus 6 of 369 (1.6 per cent) (P=0.999). Complete follow-up was available for 331 patients (79.4 per cent). There was no difference in atrophy rate between those aged less than 1 year and older boys: 1 of 37 (3 per cent) versus 9 of 294 (3.1 per cent) (P=0.999). Reoperation rates were 0 of 37 (0 per cent) and 7 of 294 (2.4 per cent) respectively (P=1.000). There were more wound infections in boys under 1 year of age: 4 of 37 (11 per cent) versus 7 of 294 (2.4 per cent) (P=0.025). Conclusion: Only 11.5 per cent of boys underwent surgery before the age of 1 year. There was no increased risk of postoperative testicular atrophy with early surgery, although there was a higher rate of wound infection. Further study is required to demonstrate that early orchidopexy is not inferior to orchidopexy undertaken in boys aged over 1 year.

Introduction Congenital anomalies are the fifth leading cause of death in children under 5years old globally (591000 deaths reported in 2016). Over 95% of deaths occur in low-income and middle-income countries (LMICs). It is estimated that two-thirds of the congenital anomaly health burden could be averted through surgical intervention and that such interventions can be cost-effective. This systematic review aims to evaluate current evidence regarding the cost-effectiveness of neonatal surgery for congenital anomalies in LMICs. Methods and analysis A systematic literature review will be conducted in PubMed, MEDLINE, Embase, Cochrane Library, Scielo, Google Scholar, African Journals OnLine and Regional WHO's African Index Medicus databases for articles on the cost-effectiveness of neonatal surgery for congenital anomalies in LMICs. The following search strings will be used: (1) congenital anomalies; (2) LMICs; and (3) cost-effectiveness of surgical interventions. Articles will be uploaded to Covidence software, duplicates removed and the remaining articles screened by two independent reviewers. Cost information for interventions or procedures will be extracted by country and condition. Outcome measurements by reported unit and cost-effectiveness ratios will be extracted. Methodological quality of each article will be assessed using the Drummond checklist for economic evaluations. The Agency for Healthcare Research and Quality's Effective Health Care Program guidance will be followed to assess the grade of the studies. Ethics and dissemination No ethical approval is required for conducting the systematic review. There will be no direct collection of data from individuals. The finalised article will be published in a scientific journal for dissemination. The protocol has been registered with PROSPERO (International Prospective Register of Systematic Reviews). Conclusion Congenital anomalies form a large component of the global health burden that is amenable to surgical intervention. This study will systematically review the current literature on the cost-effectiveness of neonatal surgery for congenital anomalies in LMICs. PROSPERO registration number CRD42020172971.

The COVID‐19 pandemic has disrupted routine hospital services globally. This study estimated the total number of adult elective operations that would be cancelled worldwide during the 12 weeks of peak disruption due to COVID‐19.

Congenital anomalies have risen to become the fifth leading cause of under-five mortality globally. The majority of deaths and disability occur in low- and middle-income countries including Ghana. This 3-year retrospective review aimed to define, for the first time, the characteristics and outcomes of neonatal surgical conditions in northern Ghana. A retrospective study was conducted to include all admissions to the Tamale Teaching Hospital (TTH) neonatal intensive care unit (NICU) with surgical conditions between January 2014 and January 2017. Data were collected on demographics, diagnosis and outcomes. Descriptive analysis was performed on all data, and logistic regression was used to predict determinants of neonatal mortality. p < 0.05 was deemed significant. Three hundred and forty-seven neonates were included. Two hundred and sixty-one (75.2%) were aged 7 days or less at presentation, with males (n = 177, 52%) slightly higher than females (n = 165, 48%). The majority were delivered by spontaneous vaginal delivery (n = 247, 88%); 191 (58%) were born in hospital. Congenital anomalies accounted for 302 (87%) of the neonatal surgical cases and 45 (96%) deaths. The most common anomalies were omphalocele (n = 48, 13.8%), imperforate anus (n = 34, 9.8%), intestinal obstruction (n = 29, 8.4%), spina bifida (n = 26, 7.5%) and hydrocephalus (n = 19, 5.5%). The overall mortality rate was 13.5%. Two-thirds of the deaths (n = 30) from congenital anomalies were conditions involving the digestive system with gastroschisis having the highest mortality of 88%. Omphalocele (n = 11, 23.4%), gastroschisis (n = 7, 14.9%) and imperforate anus (n = 6, 12.8%) contributed to the most deaths. On multivariate analysis, low birthweight was significantly associated with mortality (OR 3.59, CI 1.4–9.5, p = 0.009). Congenital anomalies are a major global health problem associated with high neonatal mortality in Ghana. The highest burden in terms of both caseload and mortality is attributed to congenital anomalies involving the digestive system, which should be targeted to improve outcomes.

Objective Outcome reporting heterogeneity impedes identification of gold standard treatments for children born with gastroschisis. Use of core outcome sets (COSs) in research reduces outcome reporting heterogeneity and ensures that studies are relevant to patients. The aim of this study was to develop a gastroschisis COS. Design and setting Systematic reviews and stakeholder nomination were used to identify candidate outcomes that were subsequently prioritised by key stakeholders in a three-phase online Delphi process and face-to-face consensus meeting using a 9-point Likert scale. In phases two and three of the Delphi process, participants were shown graphical and numerical representations of their own, and all panels scores for each outcome respectively and asked to review their previous score in light of this information. Outcomes were carried forward to the consensus meeting if prioritised by two or three stakeholder panels in the third phase of the Delphi process. The COS was formed from outcomes where ≥70% of consensus meeting participants scored the outcome 7–9 and <15% of participants scored it 1–3. Results 71 participants (84%) completed all phases of the Delphi process, during which 87 outcomes were assessed. Eight outcomes, mortality, sepsis, growth, number of operations, severe gastrointestinal complication, time on parenteral nutrition, liver disease and quality of life for the child, met criteria for inclusion in the COS. Conclusions Eight outcomes have been included in the gastroschisis COS as a result of their importance to key stakeholders. Implementing use of the COS will increase the potential for identification of gold standard treatments for the management of children born with gastroschisis.

Background: Gastroschisis is associated with less than 4% mortality in high-income countries and over 90% mortality in many tertiary paediatric surgery centres across sub-Saharan Africa (SSA). The aim of this trial is to develop, implement and prospectively evaluate an interventional bundle to reduce mortality from gastroschisis in seven tertiary paediatric surgery centres across SSA. Methods: A hybrid type-2 effectiveness-implementation, pre-post study design will be utilised. Using current literature an evidence-based, low-technology interventional bundle has been developed. A systematic review, qualitative study and Delphi process will provide further evidence to optimise the interventional bundle and implementation strategy. The interventional bundle has core components, which will remain consistent across all sites, and adaptable components, which will be determined through in-country co-development meetings. Pre- and post-intervention data will be collected on clinical, service delivery and implementation outcomes for 2-years at each site. The primary clinical outcome will be all-cause, in-hospital mortality. Secondary outcomes include the occurrence of a major complication, length of hospital stay and time to full enteral feeds. Service delivery outcomes include time to hospital and primary intervention, and adherence to the pre-hospital and in-hospital protocols. Implementation outcomes are acceptability, adoption, appropriateness, feasibility, fidelity, coverage, cost and sustainability. Pre- and post-intervention clinical outcomes will be compared using Chi-squared analysis, unpaired t-test and/or Mann-Whitney U test. Time-series analysis will be undertaken using Statistical Process Control to identify significant trends and shifts in outcome overtime. Multivariate logistic regression analysis will be used to identify clinical and implementation factors affecting outcome with adjustment for confounders. Outcome: This will be the first multi-centre interventional study to our knowledge aimed at reducing mortality from gastroschisis in low-resource settings. If successful, detailed evaluation of both the clinical and implementation components of the study will allow sustainability in the study sites and further scale-up. Registration: ClinicalTrials.gov Identifier NCT03724214.

Introduction Congenital anomalies are the fifth leading cause of death in children <5years of age globally, contributing an estimated half a million deaths per year. Very limited literature exists from low and middle income countries (LMICs) where most of these deaths occur. The Global PaedSurg Research Collaboration aims to undertake the first multicentre, international, prospective cohort study of a selection of common congenital anomalies comparing management and outcomes between low, middle and high income countries (HICs) globally. Methods and analysis The Global PaedSurg Research Collaboration consists of surgeons, paediatricians, anaesthetists and allied healthcare professionals involved in the surgical care of children globally. Collaborators will prospectively collect observational data on consecutive patients presenting for the first time, with one of seven common congenital anomalies (oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation and Hirschsprung's disease). Patient recruitment will be for a minimum of 1month from October 2018 to April 2019 with a 30-day post-primary intervention follow-up period. Anonymous data will be collected on patient demographics, clinical status, interventions and outcomes using REDCap. Collaborators will complete a survey regarding the resources and facilities for neonatal and paediatric surgery at their centre. The primary outcome is all-cause in-hospital mortality. Secondary outcomes include the occurrence of post-operative complications. 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. Ethics and dissemination At the host centre, this study is classified as an audit not requiring ethical approval. All participating collaborators have gained local approval in accordance with their institutional ethical regulations. Collaborators will be encouraged to present the results locally, nationally and internationally. The results will be submitted for open access publication in a peer reviewed journal. Trial registration number NCT03666767

Background Health systems for surgical care for children in low- and middle-income countries remain poorly understood. Our goal was to characterize the delivery of surgical care for children across Brazil and to identify associations between surgical resources and childhood mortality. Methods We performed a cross-sectional, ecological study to analyze surgical care for children in the public health system (Sistema Único de Saúde) across Brazil from 2010 to 2015. We collected data from several national databases, and used geospatial analysis (two-step floating catchment, Getis-Ord-Gi analysis, and geographically weighted regression) to explore relationships between infrastructure, workforce, access, procedure rate, under-5 mortality rate (U5MR), and perioperative mortality rate (POMR). Results A total of 246,769 surgical procedures were performed in 6,007 first level/ district hospitals and 491 referral hospitals across Brazil over the study period. The surgical workforce is distributed unevenly across the country, with 0.13–0.26 pediatric surgeons per 100,000 children in the poorer North, Northeast and Midwest regions, and 0.6–0.68 pediatric surgeons per 100,000 children in the wealthier South and Southeast regions. Hospital infrastructure, procedure rate, and access to care is also unequally distributed across the country, with increased resources in the South and Southeast compared to the Northeast, North, and Midwest. The U5MR varies widely across the country, although procedure-specific POMR is consistent across regions. Increased access to care is associated with lower U5MR across Brazil, and access to surgical care differs by geographic region independent of socioeconomic status. Conclusions There are wide disparities in surgical care for children across Brazil, with infrastructure, manpower, and resources distributed unevenly across the country. Access to surgical care is associated with improved U5MR independent of socioeconomic status. To address these disparities, policy should direct the allocation of surgical resources commensurate with local population needs.

Background: Gastroschisis is associated with less than 4% mortality in high-income countries and over 90% mortality in many tertiary paediatric surgery centres across sub-Saharan Africa (SSA). The aim of this trial is to develop, implement and prospectively evaluate an interventional bundle to reduce mortality from gastroschisis in seven tertiary paediatric surgery centres across SSA. Methods: A hybrid type-2 effectiveness-implementation, pre-post study design will be utilised. Using current literature an evidence-based, low-technology interventional bundle has been developed. A systematic review, qualitative study and Delphi process will provide further evidence to optimise the interventional bundle and implementation strategy. The interventional bundle has core components, which will remain consistent across all sites, and adaptable components, which will be determined through in-country co-development meetings. Pre- and post-intervention data will be collected on clinical, service delivery and implementation outcomes for 2-years at each site. The primary clinical outcome will be all-cause, in-hospital mortality. Secondary outcomes include the occurrence of a major complication, length of hospital stay and time to full enteral feeds. Service delivery outcomes include time to hospital and primary intervention, and adherence to the pre-hospital and in-hospital protocols. Implementation outcomes are acceptability, adoption, appropriateness, feasibility, fidelity, coverage, cost and sustainability. Pre- and post-intervention clinical outcomes will be compared using Chi-squared analysis, unpaired t-test and/or Mann-Whitney U test. Time-series analysis will be undertaken using Statistical Process Control to identify significant trends and shifts in outcome overtime. Multivariate logistic regression analysis will be used to identify clinical and implementation factors affecting outcome with adjustment for confounders. Outcome: This will be the first multi-centre interventional study to our knowledge aimed at reducing mortality from gastroschisis in low-resource settings. If successful, detailed evaluation of both the clinical and implementation components of the study will allow sustainability in the study sites and further scale-up. Registration: ClinicalTrials.gov Identifier NCT03724214.