key: cord-254506-cxdklz4u authors: Castellvi, J.; Jerico, C.; DeMiguel, A.; Camacho, D.; Mullerat, J. M.; Catala, J.; Cliville, R.; Videla, S. title: Impact On Clinical Practice Of The Preoperative Screening Of Covid-19 Infection In Surgical Oncological Patients. Prospective Cohort Study date: 2020-08-11 journal: nan DOI: 10.1016/j.ijso.2020.08.003 sha: doc_id: 254506 cord_uid: cxdklz4u Abstract Background in the oncological patient, an COVID-19-Infection, whether symptomatic or asymptomatic, a surgical procedure may carry a higher postoperative morbidity and mortality. The aim of this study was to describe the impact on clinical practice of sequential preoperative screening for COVID-19-infection in deciding whether to proceed or postpone surgery. Methods prospective, cohort study, based on consecutive patients’ candidates for an oncological surgical intervention. Sequential preoperative screening for COVID-19-infection: two-time medical history (telematic and face-to-face), PCR and chest CT, 48 hours before of surgical intervention. COVID-19-infection was considered positive if the patient had a suggestive medical history and/or PCR-positive and/or CT of pneumonia. Results Between April 15th and May 4th, 2020, 179 patients were studied, 97 were male (54%), mean (sd) age 66.7(13,6). Sequential preoperative screening was performed within 48 hours before to surgical intervention. The prevalence of preoperative COVID-19-infection was 4.5%, 95%CI:2.3-8.6% (8 patients). Of the operated patients (171), all had a negative medical history, PCR and chest CT.. The complications was 14.8% (I-II) and 2.5% (III-IV). There was no mortality. The hospital stay was 3.1 (sd 2.7) days. In the 8 patients with COVID-19-infection, the medical history was suggestive in all of them, 7 presented PCR-positive and 5 had a chest CT suggestive of pneumonia. The surgical intervention was postponed between 15 and 21 days. Conclusion preoperative screening for COVID-19-infection using medical history and PCR helped the surgeon to decide whether to go ahead or postpone surgery in oncological patients. The chest CT may be useful in unclear cases. In the present situation of COVID-19 pandemia, it has been reported that oncological surgical patients have a higher risk of being infected with COVID-19 than other non-oncological surgical patients due to the cancer itself, the immunosuppression related to it as well as to the oncological and surgical treatments [1] [2] [3] [4] . Patients with cancer and specially those who will undergo surgery or neoadjuvant treatment and developed COVID-19-infection, have a higher rate of morbidity and mortality as well as ICU (Intensive Cure Unit) admissions. Furthermore, the clinical deterioration of these patients is much more acute when compared with non-infected patients [1] . In the current climate of maximal pandemic extension, it has been necessary to postpone the surgical intervention (SI) in these patients and, in some cases, offer them alternative neoadjuvant treatment. The European Cancer Organisation (ECCO) advises that oncological patients who require a SI, adjuvant or neoadjuvant treatment, must be tested and cleared for infection to reduce their morbidity and mortality. Three preoperative screening tests have been proposed: a detailed history, a COVID-19 PCR determination and a chest radiological imaging (CT or Xray), despite not having any control studies available [6] [7] [8] [9] [10] [11] [12] . There is controversy over the use of PCR, due to its limited availability as well as over its negative predictive value, so some units suggest carrying out a preoperative CT chest due to its high sensitivity and high negative predictive value [6] [7] 13, 14, 15] . We must stress out that as of yet there are no available clinical studies that have tested the diagnostic efficacy of these preoperative screening diagnostic tools for the virus. With this is in mind, it is necessary to evaluate if these preoperative screening tests for COVID-19 are accurate for the diagnosis of symptomatic or asymptomatic COVID-19 infection and/or an asymptomatic latent pneumonia prior to a SI, in order to help the clinician decide. This will allow to i) reduce morbidity and mortality in oncological patients and ii) protect the healthcare professionals involved in treating these patients. Therefore, our working hypothesis is that sequential preoperative screening: clinical (detailed history), PCR and radiology (chest CT) of COVID-19 infection and pneumonia will identify symptomatic and asymptomatic infected patients. This information will be crucial for the surgeon at the time of deciding for or against a SI in the oncological patient. J o u r n a l P r e -p r o o f Therefore, the aim of this study is to describe the impact of sequential preoperative screening for COVID-19-infection at the point of deciding to proceed or postpone surgery. PATIENTS AND METHODS and face-to-face 2 days maximum before surgery) and a PCR for COVID-19 (2 days maximum before surgery). The same day of screening a chest CT was done. In case of suspicion of COVID-19-infection during the screening, the intervention was delayed. If the patient presented symptoms suggestive of COVID-19 infection during the postoperative period, a PCR was performed. If the patient had a PCR positive result, he/she was isolated and a chest CT was performed. Since there is no definitive gold standard diagnostic test for asymptomatic suggestive of COVID-19 infection in the previous 4 weeks and/or a positive PCR for COVID-19 2 days before surgery and/or a radiographic image of pneumonia 2 days before surgery. The impact on clinical practice was evaluated by the number of patients in whom surgery was delayed either due to suspected COVID-19-infection or due to the patient objecting to being operated because of fear of COVID-infection. Sample Size: due to the exploratory nature of our aim, no formal calculation of sample size was performed. The sample size was defined as all oncological patients screened for COVID-19-infection before being operated during the inclusion period. Statistical Procedures: baseline characteristics were summarized using standard descriptive statistics, and a descriptive analysis was carried out. Prevalence (95% confidence intervals -95% CI) was calculated based on the proposed to be operated. Due to the COVID-19 pandemia, in 80% of these patients the scheduled surgery had been postponed. Two of them rejected the surgery due to fear of being operated during the pandemic period. Therefore, the study population for the analysis was of 179 patients. Figure 1 presents the patients' flow chart. CT to detect pneumonia associated to COVID infection [8, 9, 10, 14, 15, 17] . Moreover, this confirms the role of chest CT in ruling out borderline cases. Only We believe that an exhaustive and detailed history is the main screening tool and the foundation for screening for infection. PCR data can be a good support for the history. The chest CT would not be necessary in all cases. On the other hand, CT has a very high sensitivity when the patient has pneumonia [1] . Therefore, chest CT should not be a routine part of the screening battery except in unclear cases. We have not included the plain chest Xray in our study as it has a 40% of false negative results for diagnosis of pneumonia, and since we're dealing with high risk patients [13, 14, 15] . Our study is subject to some limitations. This study only involved one centre, which might underestimate or overestimate the results beyond the population and conditions studied. Likewise, the sample size, and the period of inclusion (3 weeks during COVID-19 pandemic) and follow-up (28 days), may also underestimate or overestimate the results. We must also highlight the lack of a gold standard diagnostic test for asymptomatic COVID-19-infection. In conclusion, the preoperative screening for COVID-19-infection using medical history and PCR helped the surgeon decide whether to proceed or postpone surgery in oncological patients during the COVID crisis. The chest CT scan may bring useful information in doubtful cases. Not commissioned, externally peer-reviewed. J o u r n a l P r e -p r o o f The following additional information is required for submission. Please note that failure to respond to these questions/statements will mean your submission will be returned. If you have nothing to declare in any of these categories, then this should be stated. Declarations of interest: none This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The work has been approved by the appropriate ethical committees related to the institution(s) in which it was performed and the subjects gave informed consent to the work. Ref: PR179 20 (CSI 20 45) The data were collected anonymously in a database. This database is available for assessment, without breaching any patient information laws. Please enter the name of the registry, the hyperlink to the registration and the unique identifying number of the study. You can register your research at Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China Risk of COVID-19 for cancer patients Risk of COVID-19 for patients with cancer American College of Surgeons. COVID-19: Recommendations for Management of Elective Surgical Procedures 2020 Viral Load of SARS-CoV-2 in Chest CT for Typical 2019-nCoV Pneumonia: Relationship to Negative RT-PCR Testing Correlation of Chest CT and RT-PCR Testing in Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases Chest CT Findings in Coronavirus Disease-19 (COVID-19): Relationship to Duration of Infection Performance of radiologists in differentiating COVID-19 from viral pneumonia on chest CT. Radiology. 10 de marzo de 2020 Initial CT findings and temporal changes in patients with the novel coronavirus pneumonia (2019-nCoV): a study of 63 patients in Wuhan, China Emerging 2019 Novel Coronavirus (2019-nCoV) Pneumonia COVID-19): Role of Chest CT in Diagnosis and Management Coronavirus Disease 2019(COVID-19): A Perspective from China Guideline: Strengthening the Reporting of Cohort Studies in Surgery Heidar Tayebinia Diagnosis and treatment of coronavirus disease Name of the registry: Research Registry 2. Unique Identifying number or registration ID Hyperlink to your specific registration Conception and design of the study Project administration. review & editing. Supervision. Validation. Roles: Writing -original draft; Writing -review & editing C. Jerico: conception and design of the study. Investigation; Methodology. Review & editing A De Miguel: acquisition of data Data curation Mullerat: review & editing J. Catala: methodology. Conceptualization R Cliville: methodology. Conceptualization S. Videla: conception and design of the study Dr Rodriguez Surgical pathway manager for enabling the study. Dra A Coloma for helping in designing the study protocols infection. Dr Masdeu, head of anaesthetics for adapting to the study protocols. Sra I Lopez. N Maiz, N Massana, D Rejon, M Moral for managing the patients' pathways and data collection. To surgycal nursery for help in these difficult times. The guarantor accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish. The authors accept full responsibility for the work and the conduct of the study, had access to the data, and controlled the decision to publish. The work described has not been published previously and it is not under consideration for publication elsewhere. The publication is approved by all authors and tacitly or explicitly by the responsible authorities where the work was carried out, and if accepted, it will not be published elsewhere in the same form, in English or in any other language, including electronically without the written consent of the copyright-holder