Peri-operative SARS-CoV-2 infection increases postoperative mortality. The aim of this study was to determine the optimal duration of planned delay before surgery in patients who have had SARS-CoV-2 infection. This international, multicentre, prospective cohort study included patients undergoing elective or emergency surgery during October 2020. Surgical patients with pre-operative SARS-CoV-2 infection were compared with those without previous SARS-CoV-2 infection. The primary outcome measure was 30-day postoperative mortality. Logistic regression models were used to calculate adjusted 30-day mortality rates stratified by time from diagnosis of SARS-CoV-2 infection to surgery. Among 140,231 patients (116 countries), 3127 patients (2.2%) had a pre-operative SARS-CoV-2 diagnosis. Adjusted 30-day mortality in patients without SARS-CoV-2 infection was 1.5% (95%CI 1.4-1.5). In patients with a pre-operative SARS-CoV-2 diagnosis, mortality was increased in patients having surgery within 0-2 weeks, 3-4 weeks and 5-6 weeks of the diagnosis (odds ratio (95%CI) 4.1 (3.3-4.8), 3.9 (2.6-5.1) and 3.6 (2.0-5.2), respectively). Surgery performed ≥ 7 weeks after SARS-CoV-2 diagnosis was associated with a similar mortality risk to baseline (odds ratio (95%CI) 1.5 (0.9-2.1)). After a ≥ 7 week delay in undertaking surgery following SARS-CoV-2 infection, patients with ongoing symptoms had a higher mortality than patients whose symptoms had resolved or who had been asymptomatic (6.0% (95%CI 3.2-8.7) vs. 2.4% (95%CI 1.4-3.4) vs. 1.3% (95%CI 0.6-2.0), respectively). Where possible, surgery should be delayed for at least 7 weeks following SARS-CoV-2 infection. Patients with ongoing symptoms ≥ 7 weeks from diagnosis may benefit from further delay.
SARS-CoV-2 has been associated with an increased rate of venous thromboembolism in critically ill patients. Since surgical patients are already at higher risk of venous thromboembolism than general populations, this study aimed to determine if patients with peri-operative or prior SARS-CoV-2 were at further increased risk of venous thromboembolism. We conducted a planned sub-study and analysis from an international, multicentre, prospective cohort study of elective and emergency patients undergoing surgery during October 2020. Patients from all surgical specialties were included. The primary outcome measure was venous thromboembolism (pulmonary embolism or deep vein thrombosis) within 30 days of surgery. SARS-CoV-2 diagnosis was defined as peri-operative (7 days before to 30 days after surgery); recent (1-6 weeks before surgery); previous (≥7 weeks before surgery); or none. Information on prophylaxis regimens or pre-operative anti-coagulation for baseline comorbidities was not available. Postoperative venous thromboembolism rate was 0.5% (666/123,591) in patients without SARS-CoV-2; 2.2% (50/2317) in patients with peri-operative SARS-CoV-2; 1.6% (15/953) in patients with recent SARS-CoV-2; and 1.0% (11/1148) in patients with previous SARS-CoV-2. After adjustment for confounding factors, patients with peri-operative (adjusted odds ratio 1.5 (95%CI 1.1-2.0)) and recent SARS-CoV-2 (1.9 (95%CI 1.2-3.3)) remained at higher risk of venous thromboembolism, with a borderline finding in previous SARS-CoV-2 (1.7 (95%CI 0.9-3.0)). Overall, venous thromboembolism was independently associated with 30-day mortality ). In patients with SARS-CoV-2, mortality without venous thromboembolism was 7.4% (319/4342) and with venous thromboembolism was 40.8% (31/76). Patients undergoing surgery with peri-operative or recent SARS-CoV-2 appear to be at increased risk of postoperative venous thromboembolism compared with patients with no history of SARS-CoV-2 infection. Optimal venous thromboembolism prophylaxis and treatment are unknown in this cohort of patients, and these data should be interpreted accordingly.
Objectives: To identify the implementation strategies used in World Health Organization Surgical Safety Checklist (SSC) uptake in low-and middleincome countries (LMICs); examine any association of implementation strategies with implementation effectiveness; and to assess the clinical impact. Background: The SSC is associated with improved surgical outcomes but effective implementation strategies are poorly understood. Methods: We searched the Cochrane library, MEDLINE, EMBASE and PsycINFO from June 2008 to February 2019 and included primary studies on SSC use in LMICs. Coprimary objectives were identification of implementation strategies used and evaluation of associations between strategies and implementation effectiveness. To assess the clinical impact of the SSC, we estimated overall pooled relative risks for mortality and morbidity. The study was registered on PROSPERO (CRD42018100034). Results: We screened 1562 citations and included 47 papers. Median number of discrete implementation strategies used per study was 4 (IQR: 1-14, range 0-28). No strategies were identified in 12 studies. SSC implementation occurred with high penetration (81%, SD 20%) and fidelity (85%, SD 13%), but we did not detect an association between implementation strategies and implementation outcomes. SSC use was associated with a reduction in mortality (RR 0.77; 95% CI 0.67-0.89), all complications (RR 0.56; 95% CI 0.45-0.71) and infectious complications (RR 0.44; 95% CI 0.37-0.52). Conclusions:The SSC is used with high fidelity and penetration is associated with improved clinical outcomes in LMICs. Implementation appears well supported by a small number of tailored strategies. Further application of implementation science methodology is required among the global surgical community.
Summary Despite the ongoing coronavirus disease 2019 (COVID‐19) pandemic, elective paediatric surgery must continue safely through the first, second and subsequent waves of disease. This study presents outcome data from a children's hospital in north‐west England, the region with the highest prevalence of COVID‐19 in England. Children and young people undergoing elective surgery isolated within their household for 14 days, then presented for real‐time reverse transcriptase polymerase chain reaction testing for severe acute respiratory syndrome coronavirus disease‐2 (SARS‐CoV‐2) within 72 h of their procedure (or rapid testing within 24 h in high‐risk cases), and completed a screening questionnaire on admission. Planned surgery resumed on 26 May 2020; in the four subsequent weeks, there were 197 patients for emergency and 501 for elective procedures. A total of 488 out of 501 (97.4%) elective admissions proceeded, representing a 2.6% COVID‐19‐related cancellation rate. There was no difference in the incidence of SARS‐CoV‐2 among children and young people who had or had not isolated for 14 days (p > 0.99). One out of 685 (0.1%) children who had surgery re‐presented to the hospital with symptoms potentially consistent with SARS‐CoV‐2 within 14 days of surgery. Outcomes were similar to those in the same time period in 2019 for length of stay (p = 1.0); unplanned critical care admissions (p = 0.59); and 14‐day hospital re‐admission (p = 0.17). However, the current cohort were younger (p = 0.037); of increased complexity (p < 0.001) and underwent more complex surgery (p < 0.001). The combined use of household self‐isolation, testing and screening questionnaires has allowed the re‐initiation of elective paediatric surgery at high volume while maintaining pre‐COVID‐19 outcomes in children and young people undergoing surgery. This may provide a model for addressing the ongoing challenges posed by COVID‐19, as well as future pandemics.
Summary Background The local anesthetic, levobupivacaine, is the safer enantiomer of racemic bupivacaine. Present protocols for levobupivacaine are based on studies and pharmacokinetic modeling with racemic bupivacaine. Aims The aim is to investigate total serum levobupivacaine concentrations after a caudalepidural loading dose followed by a maintenance infusion over 48 hours in infants aged 3‐6 months. Methods The clinical trial was conducted in eight infants aged 3‐6 months, undergoing bladder exstrophy repair. Pharmacokinetic modeling allowed optimization of clinical sampling to measure total levobupivacaine and α1‐acid glycoprotein and prediction of the effect of α1‐acid glycoprotein on levobupivacaine plasma protein binding. Results The observed median total levobupivacaine serum concentration was 0.30 mg/L (range: 0.20‐0.70 mg/L) at 1 hour after the loading dose of 2 mg/kg. The median total levobupivacaine concentration after 47 hours of infusion, at 0.2 mg/kg/h, was 1.21 mg/L (0.07‐1.85 mg/L). Concentrations of α1‐acid glycoprotein were found to rise throughout the study period. Pharmacokinetic modeling suggested that unbound levobupivacaine quickly reached steady state at a concentration of approximately 0.03 mg/L. Conclusion The study allows the development of a pharmacokinetic model, combining levobupivacaine and α1‐acid glycoprotein data. Modeling indicates that unbound levobupivacaine quickly reaches steady state once the infusion is started. Simulations suggest that it may be possible to continue the infusion beyond 48 hours.
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