There are 4 clinical trials
There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery, specially vascular surgery. Capturing real-world data and sharing Spanish national experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care. The global community has recognised that rapid dissemination and completion of studies in COVID-19 infected patients is a high priority, so we encourage all stakeholders (local investigators, ethics committees, IRBs) to work as quickly as possible to approve this project. This investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.
Description: 30-days mortality after vascular surgery in patients with COVID-19 infectionMeasure: 30-days mortality Time: 30-days
Description: 7-days mortality after vascular surgery in patients with COVID-19 infectionMeasure: 7-days mortality Time: 7-days
Description: 30-days reoperation after vascular surgery in patients with COVID-19 infectionMeasure: 30-days reoperation Time: 30-days
Description: Postoperative ICU admission after vascular surgery in patients with COVID-19 infectionMeasure: Postoperative ICU admission Time: 30-days
Description: Postoperative respiratory failure after vascular surgery in patients with COVID-19 infectionMeasure: Postoperative respiratory failure Time: 30-days
Description: Postoperative acute respiratory distress syndrome (ARDS) after vascular surgery in patients with COVID-19 infectionMeasure: Postoperative acute respiratory distress syndrome (ARDS) Time: 30-days
Description: Postoperative sepsis after vascular surgery in patients with COVID-19 infectionMeasure: Postoperative sepsis Time: 30-days
Overall mortality of COVID-19 is variable and has been reported to be between less than 1% and 7%. Many authors around the world also reported data on hospitalization rate, need for intensive care unit (ICU) care and need for mechanical ventilation in SARS-CoV-2 infected patients. To provide anesthetic and surgical care to SARS-CoV-2 infected patients, many health workers have to organize surgical platforms, personal protections and in-hospital trajectories to prevent dissemination and cross-contamination. However, no data has been published on the surgical need of these patients, their postoperative outcomes and the impact they may have on the operating room. Postoperative outcomes in SARS-CoV-2 infected patients are completely unknown. Expected benefits that justify a surgical procedure may be different in this population as well as the effects of preoperative characteristics on postoperative outcomes. The surgical needs of these patients, their postoperative outcomes as well as the associated workload imposed to operating rooms are unknown. There is a need to better quantify these and inform needed surgical resources in a pandemic. To address this knowledge gap, the investigators propose to conduct a multicenter observational cohort study in SARS-CoV-2 infected patients undergoing a surgical procedure.
Description: Survival was calculated from the date of participant randomization to the date of participant death due to any cause, within 30 days after the surgery. If the participant was discharged from the hospital and not seen afterwards, the date of hospital discharge was entered as the last day seen alive.Measure: Survival up to 30 days Time: 30 days post-operation
Description: The respiratory complications were recorded as diagnosed by medical personnel and/or medical imaging. The complications included atelectasis, pneumonia, acute respiratory distress syndrome (ARDS) and pulmonary aspiration.Measure: Occurrence of postoperative respiratory complications Time: 30 days post-operation
Description: The infection site complications were recorded as diagnosed by medical personnel and/or medical imaging. The infectious site included surgical incision or puncture site, surgical abscess, anastomotic leak, central nervous system, urinary tract infection, osteomyelitis, positive blood culture, etc. A postoperative infection had to be accompanied by an antimicrobial therapy lasting longer than 72 hours. In the event a patient suffered from two infections in the same site, both dates were recorded.Measure: Occurrence of postoperative non-pulmonary infectious complications Time: 30 days post-operation
Description: The grade of AKI was classified according to the KDIGO-AKI criteria using the highest reported creatinine or the need for new renal replacement therapy after surgery, including any mode of renal replacement therapy.Measure: Occurrence of acute kidney injury (AKI) Time: 30 days post-operation
Description: The thromboembolic complications were recorded as diagnosed by medical personnel and/or medical imaging. These included myocardial infarction, stroke, pulmonary embolism and cardiac arrest. Myocardial infarction was defined as a physician's diagnosis of a MI, which includes ST Elevation Myocardial Ischemia (STEMI) or Non-ST Elevation Myocardial Ischemia (NSTEMI).Measure: Occurrence of postoperative thromboembolic complications Time: 30 days post-operation
Description: The dates for all ICU admissions and dates of ICU discharge were recorded. If the patient was readmitted to ICU following his initial admission to ICU, the dates for admissions and discharges were recorded.Measure: The need for a new postoperative ICU admission Time: 30 days post-operation
Description: The number of days of hospital length of stay was calculated using the difference between the local date of discharge from the hospital and the date of hospital admission (day of surgery if ambulatory surgery). If the patient died during surgery or prior to hospital discharge, the patient's date of death was recorded as the date of discharge.Measure: Hospital length of stay Time: An average of 7 days
Description: The total number of days the patient was on invasive mechanical support was recorded. If mechanical ventilation was weaned and started again, the days when the patients were under mechanical ventilation were indicated. Non-invasive ventilation or high-flow nasal cannula (HFNC) were not included.Measure: 30-day mechanical ventilation free-days Time: 30 days post-operation
Description: The total number of days the patient was: on invasive mechanical ventilator, under vasopressor therapy for more than 2 hours up to 30 days after surgery and spent under renal replacement therapy was recorded.Measure: 30-day organ dysfunction free days Time: 30 days post-operation
Description: Any surgical reintervention in the operating room either related or unrelated to the initial intervention was recorded.Measure: Surgical reinterventions Time: 30 days post-operation
Description: The dates for all ICU admissions and dates of ICU discharge were recorded. If the patient was admitted to ICU just after the index surgery, the date of ICU admission and time at which it occurred were recorded.Measure: Any ICU admission during the index hospital stay Time: 30 days post-operation
Description: Time of room cleaning was defined from the time at which patient was transferred out of the operating room to the time at which the cleaning of the operating room ended.Measure: Time of room cleaning Time: Number of minutes following patient transfer out of the operating room to end of cleaning, up to 60 minutes.
Description: Survival was calculated from the date of participant randomization to the date of participant death due to any cause, within 6 months after the surgery.Measure: 6-month survival Time: 6 months post-operation
A multi-centre, observational cohort study will be carried out in consecutive patients operated on for urgent digestive pathology. Two cohorts will be defined: the 'pandemic' cohort, which will include all patients [COVID-19-positive or negative] operated on for emergency digestive pathology during the months of March to June 2020; and the control cohort, which will include all patients operated on for emergency digestive pathology during the months of March to June 2019. Information will be gathered on demographic characteristics, clinical and analytical parameters, scores on the usual risk scales for quality management in a General Surgery service (POSSUM, P-POSSUM and LUCENTUM scores), prognostic factors applicable to all patients, specific factors for patients infected with SARS-CoV-2, complications and postoperative mortality (at 30 and 90 postoperative days). In the pandemic cohort it will be detailed whether or not the patient was infected with SARS-CoV-2. The main objective will be to determine the incidence of postoperative complications and mortality. This variable will be analysed in the "full analysis set" population. Secondary objective will be to develop a specific postoperative risk propensity model for SARS-CoV-2 infected patients.
Description: Mortality for any cause at 30 days after urgent gastrointestinal surgery.Measure: 30-day mortality Time: 30 days post-surgery
Description: Mortality for any cause within 90 days of surgeryMeasure: 90-day mortality Time: 90 days post-surgery
Description: Postoperative complications within 30 days of surgery: classic postoperative complications, typical complications after digestive surgery and/or complications specifically associated with the evolution of COVID-19Measure: Postoperative complications Time: 30 days post-surgery
Description: Postoperative complications within 30 days of surgery graded as equal or superior to IIIA grade according to the Clavien-Dindo classificationMeasure: Severe complications Time: 30 days post-surgery
Description: Number of days of hospital stay from the day of admission to the date of hospital discharge or deathMeasure: Lenght of stay Time: 90 days post-surgery
Observational study to determine the optimal timing for surgery following SARS-CoV-2 infection and assess key global surgery indicators.
Description: Mortality at 30 days after surgeryMeasure: Post-operative mortality Time: 30 days after surgery
Description: Mortality while the patient is admitted to hospitalMeasure: In-patient mortality Time: 30 days after surgery
Description: 30-day postoperative pulmonary complications (pneumonia [CDC definition], ARDS, unexpected ventilation)Measure: Post-operative pulmonary complications Time: 30 days after surgery
Description: 30-day venous thromboembolism (deep vein thrombosis/ pulmonary embolism)Measure: Post-operative venous thromboembolism Time: 30 days after surgery
Description: 30-day Clavien-Dindo gradeMeasure: Post-operative complications Time: 30 days after surgery
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports