Increase in serious adverse events; Increase in reports involving products marketed under the Small Animal Exemption Scheme; Decrease in injection site reactions. These are some of the results from the surveillance work carried out by the pharmacovigilance unit at the Veterinary Medicines Directorate (VMD), as discussed by Giles Davis and colleagues.
Introduction
Defect size and closure technique in neonates with congenital diaphragmatic hernia (CDH) has long term consequences for morbidity in survivors. Although subjective operative reporting of defect size has been standardised, objective evaluation is lacking. There is no reported optimum closure technique related to size and position of diaphragmatic defect. We aimed to objectively describe diaphragmatic defects and repair methods at the time of neonatal CDH repair.
Methods
A national, three centre cohort feasibility study was undertaken over a 4-month period. Data collection was registered as service evaluation at participating centres. All surviving neonates with CDH undergoing defect closure were eligible. Anonymised data were collected using a RedCAP database. Data collection variables (n = 47) included both antenatal and postnatal measures. Data were checked for normality and reported as mean±SD or median (IQR).
Results
12 neonates were eligible for inclusion, 10 (83%) were included. Observed/Expected Lung Head Ratio (%) was reported in 5 cases (45±8), neonates were term, male (60%), birth weight (3.3±0.5kg). 80% of patients had a laparotomy, 80% had a left-sided defect, 60% a patch repair with PTFE and 60% graded defect size C. Poorly reported variables included pre-operative oxygenation and defect size was measured in 30%.
Discussion
Data collection through RedCAP was feasible and most variables were documented. Simplifying the intraoperative data collection form and providing clear instructions for taking measurements may improve reporting. A further pilot study with these modifications and improving engagement through advertisement, emails and online presence is intended to optimize the study before roll-out.
Background We present a national data series to determine the incidence, outcomes and training opportunities for laparoscopic cholecystectomy among children <16yrs in Scotland as performed by paediatric surgeons. Methods A retrospective cohort study was performed reviewing laparoscopic cholecystectomy performed at the three children’s hospitals in Scotland. Using the National Records Scotland Database mid-year population estimates; age and sex specific annual incidence rates of laparoscopic cholecystectomy were calculated between 1998-2015. Trends in the observed case mix were tested using univariate linear regression and students t-test. Results Between 1998–2015; 141 paediatric laparoscopic cholecystectomies were performed. The annual rate of cholecystectomy increased from 0.10/100,000 to 0.88/100,000 (p = 0.069). Sex specific incidences were identified; 0.00–0.90/100,000 (p = 0.098) in girls and 0.20–0.86/100,000 in boys (p = 0.28). Cholecystectomy was more frequent in girls (63%; p = 0.04). No major complications, defined as common bile duct injury or mortality were identified. Overall; 75% of cases were performed by consultants (n = 17 consultants, median = 5 cases, p < 0.05) and 25% by trainees. Conclusion We have demonstrated that despite a low national case load (8 laparoscopic cholecystectomies per year) paediatric surgeons have been able to perform laparoscopic cholecystectomy safely without major morbidity.
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