Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

Implementación de un programa de mejora en cirugía colorrectal y diagnóstico precoz de sus complicaciones

Introducción y objetivos: La cirugía colorrectal ha estado marcada a lo largo de la historia por su elevada tasa de complicaciones, en especial, la Infección del Sitio Quirúrgico (ISQ) directamente relacionada con la Fuga de Anastomosis (FA), que conlleva una amenaza para la recuperación de los pacientes, un gran consumo de recursos sanitarios y un hándicap para el cirujano. El objetivo del presente estudio es analizar la incidencia de complicaciones graves y FA en cirugía colorrectal electiva, evaluar la utilidad de los marcadores inflamatorios (Proteína C Reactiva y Procalcitonina) en el diagnóstico precoz de dichas complicaciones e implementar un programa de mejora para minimizarlas y diagnosticarlas de manera temprana. Material y método: Se realizó un primer estudio prospectivo observacional incluyendo a los pacientes sometidos a cirugía colorrectal programada con anastomosis desde el 1 de octubre de 2017 al 30 de mayo de 2018, para conocer la incidencia de complicaciones, su morbimortalidad y los factores asociados, comprobando si la alteración de los marcadores inflamatorios (PCR y PCT) servía como herramienta para el diagnóstico precoz de FA. Además, se realizó un análisis de sensibilidad, especificidad y valores predictivos y se calcularon las curvas ROC de dichos marcadores y sus puntos de corte mediante el ABC. Tras monitorizar nuestros resultados y validar en nuestro medio la utilidad de los marcadores inflamatorios se implementó un protocolo de mejora en cirugía colorrectal electiva y de diagnóstico precoz de sus complicaciones entre marzo de 2019 y mayo de 2020. Posteriormente, se realizó un estudio antes y después de la aplicación del protocolo mediante: (1) Un análisis descriptivo de las variables. (2) Una comparación univariante entre ambos grupos. (3) Un estudio multivariante describiendo las variables significativas para nuestro estudio. Resultados: 234 pacientes fueron incluidos. 95 del estudio de validación de marcadores inflamatorios (grupo Pre-protocolo) y 139 del grupo tras la aplicación del protocolo de mejora (grupo Protocolo). Tras aplicar las curvas ROC y calcular el ABC de PCT al 3º y 5º día postoperatorio, se obtuvo un ABC para PCT de 0,698 y 0,703 respectivamente (considerándose un test poco/moderadamente fiable). En cambio, el ABC para PCR al 3º día fue de 0,808 para un punto de corte de 15,3 mg/dL. Los mejores resultados como predictor de FA los proporcionó la determinación de PCR al 5º día, con un ABC de 0,939 para niveles superiores a 9,1 mg/dL. Tras la aplicación del protocolo se compararon ambos grupos obteniendo una disminución significativa de las complicaciones graves (sobre todo grado IV de Clavien-Dindo) en el grupo Protocolo (de un 22,7% a un 6,3%), así como una reducción en la incidencia de FA (de un 14,7% a un 2,2%). Por otra parte, observamos una disminución significativa de las reintervenciones, menor necesidad de ingreso en UCI, una menor estancia hospitalaria y menos reingresos. Al realizar el análisis multivariante, la aplicación del protocolo supuso un factor protector sobre el desarrollo de FA (OR 0,144, - IC 95% (0,039 - 0,526)). Conclusiones: La morbilidad de la cirugía colorrectal electiva en el grupo Pre-protocolo fue del 46,3%, asociándose en su mayoría a complicaciones graves (grado IV y V de Clavien-Dindo), siendo la tasa de FA del 14,7%. Por otra parte, la PCR ha demostrado ser un marcador fiable y precoz de FA entre el 3º y 5º día postoperatorio, permitiendo un alta temprana con valores por debajo de los puntos de corte obtenidos. Nuestro protocolo de mejora ha demostrado disminuir significativamente la morbilidad, la gravedad de las complicaciones, la tasa de FA, la estancia y reingresos hospitalarios.Background and aim of the study: Colorectal surgery has been marked throughout history by its high rate of complications, especially Surgical Site Infection (SSI) directly related to Anastomotic Leakage (AL), supposing a threat to the patient`s recovery, a large consumption of healthcare resources and a handicap for the surgeon. The objective of this study is to analyze the incidence of severe complications and AL in elective colorectal surgery, to evaluate the usefulness of inflammatory markers (C-Reactive Protein and Procalcitonin) in the early diagnosis of these complications and implement an improvement program to minimize and diagnose them earlier. Methods: A first analytical, prospective, observational study was performed, including patients undergoing scheduled colorectal surgery with anastomosis, at Morales Meseguer General Hospital from October 1, 2017 to May 30, 2018, to determine the incidence of complications, their morbidity and mortality and associated risk factors, checking whether the alteration of inflammatory markers (CRP and PCT) served as a tool for the early diagnosis of AL. In addition, an analysis of sensitivity, specificity and predictive values was performed, and the ROC curves of these markers and their cut-off points were calculated using AUC. After monitoring our results and validating the usefulness of inflammatory markers in our environment, an early diagnosis and improvement protocol was implemented in elective colorectal surgery between March 2019 and May 2020. Subsequently, a before-and-after study was carried out following the application of the new protocol through: (1) A descriptive analysis of the variables of the two groups. (2) A univariate comparison between both groups. (3) A multivariate study describing the significant variables for our study. Results: 234 patients were included: 95 from the inflammatory marker validation study (Pre-protocol group) and 139 from the group after application of the improvement protocol (Protocol group). After applying the ROC curves and calculating the AUC of the inflammatory markers (PCT and CRP) on the 3rd and 5th postoperative day, an AUC for PCT of 0.698 and 0.703 was obtained on the 3rd and 5th postoperative day, respectively (considered a poorly or moderately reliable test). In contrast, the AUC for CRP at postoperative day 3 was 0.808 for a cutoff point of 15.3 mg/dL. CRP determination on the 5th postoperative day was found to be the best predictor of anastomotic leakage, with an AUC of 0.939 for levels above 9.1 mg/dL. After application of the improvement protocol, both groups were compared, obtaining a significant decrease in severe complications (especially Clavien-Dindo grade IV) in the protocol group (from 22.7% to 6.3%), as well as a reduction in the incidence of AL (from 14.7% to 2.2%). A significant decrease in reoperations, less need for admission to the Intensive Care Unit, a shorter hospital stay and fewer readmissions were also observed. In the multivariate analysis, the application of the new protocol was a protective factor for the development of AL (OR 0.144, - 95% CI (0.039 - 0.526)). Conclusions: The morbidity of elective colorectal surgery in the Pre-protocol group was 46.3%, mostly associated with serious complications (Clavien-Dindo grade IV and V), with the AL rate being 14.7%. CRP has shown to be a reliable early marker of AL between the 3rd and 5th postoperative days, allowing early discharge with values below the cut-off points obtained. Our improvement protocol significantly reduced morbidity, severity of complications, AL rate, hospital stay and readmissions

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)