SURgical Outcomes in COvid Patients - the SUROCO Multicenter Cohort Study (COVID-19)

Summary

Participation Requirements

Description

METHODS Objectives Primary: To describe the observed surgical needs of COVID-19 patients in Canadian centers. Secondary: To measure the association between preoperative characteristics and postoperative outcomes in COVID-19 patients. Tertiary: To quantify the operating room workload and modified wor...

METHODS Objectives Primary: To describe the observed surgical needs of COVID-19 patients in Canadian centers. Secondary: To measure the association between preoperative characteristics and postoperative outcomes in COVID-19 patients. Tertiary: To quantify the operating room workload and modified workflow associated with the surgical care of COVID-19 patients as well as impact of a viral pneumonia pandemic on surgical activities. Exposure variables: To answer the primary objective, the main variables of interest will be the surgical disease that brought the patient to the operating room, its urgent nature and the invasiveness of the surgical approach. To answer the secondary objective, the investigators will gather baseline characteristics of the COVID-19 presentation as the main exposure variables: presence of symptoms at time of surgery, number of days since first symptoms, number of days since diagnosis, recovery, presence of pulmonary infiltrates, preoperative hospitalization, preoperative need for mechanical ventilation (still in use or weaned), oxygen need at time of surgery and received treatments (antiviral, steroids, antibiotics). The investigators will also gather other demographic characteristics, baseline comorbidities, baseline laboratory values, preoperative SOFA (Sequential Organ Failure Assessment) score and intraoperative variables (type of anesthesia, type of intubation technique, blood loss, fluid balance, transfusions, duration of surgery). To answer the tertiary objective, the investigators will gather the type and number of personal protective equipment used per case in the operating room, the required time for operating room preparation and cleaning, patient extubation localization and patient disposal after surgery. Surgical care impact variables: The investigators will collect from operating room administrative databases the number of surgeries performed during the period of observation and the number of surgeries performed during a comparative period of observation of the preceding year in all sites. The investigators will also collect the mean time from operating room entry to room exit and the mean time from operating room exit to end of cleaning both in surgeries of the preceding year and in surgeries of the period of observation. Variable definitions: All COVID-19 variables will be based on either the day when symptoms start as reported by the patient or the first day of diagnosis (either clinical or by RT-PCR from either an oronasopharyngeal swab or an endotracheal specimen). The investigators will also capture asymptomatic SARS-CoV-2 carrier. Recovery at surgery will be defined based on the latest available definition of a healed patient as provided by health authorities. . Surgical disease will be defined as the one reported by the surgeon. Surgeries will be further categorized into the following categories: neurosurgical (head, neck and spine), cardiac, thoracic, major vascular (intrathoracic and/or intra-abdominal), non-vascular abdominal (laparotomy or laparoscopy), urogenital (urology and/or gynecology), non-spine orthopedics, peripheral vascular, ENT and other. Any neurosurgical, cardiac, thoracic, major vascular or non-vascular abdominal surgery will be defined as a major surgery. The investigators will capture the surgical approach (minimally invasive or invasive) and the urgent nature of the procedure. Minimally invasive surgery will be defined as a one that does not need to open an anatomical cavity (laparoscopy, thoracoscopy, endoluminal). Urgency of surgery will be defined as one that needs to be done within 6 hours (emergent), between 6 and 24 hours (urgent) and can wait for more than 24 hours (non-urgent). The investigators will measure survival up to 30 days after surgery and survival up to 6 months will also be captured. The investigators will use existing definitions for the postoperative pulmonary complications outcome. Non-pulmonary infectious complications will be defined as any infection that needed antibiotics for more than 72 hours. Acute kidney injury will be defined by the creatinine difference of the KDIGO-AKI criteria. Myocardial infraction and stroke will be defined as reported by treating physicians. Mechanical ventilation will be defined as any mechanical support (non-invasive or invasive). All 30-day outcomes will include any day with the outcome and the 30-day organ dysfunction free days will use existing definitions. Time of room cleaning will be defined from patient transfer out of the operating room to end of cleaning. Sample size: The investigators plan a convenient sample size depending on the number of patients and center included. Inclusion will start on the 13th of March 2020. A formal statistical analytic plan (SAP) will be proposed according to the power this cohort may provide. The SAP will be published before any statistical analysis is conducted. Analyses: Descriptive analyses of baseline characteristics and outcomes of COVID-19 confirmed patients (symptomatic and asymptomatic) will be conducted. The primary analysis will be a determination multivariable model on survival of these patients up to 30 days after surgery. A multivariable Cox model will include presence of symptoms, preoperative oxygen need and urgency of surgery as independent variables and a frailty factor a center random effect. The secondary analyses will be descriptive analyses of suspected and healted patients and a similar multivariable survival model on all patients included in this study (confirmed, suspected or healed. Preoperative oxygen need, urgency of surgery and disease status (confirmed, suspected or healed) will be included as independent variables in this analysis. Also, the following outcomes will be reported descriptively: proportion of patients with pulmonary complications, thromboembolic complications, non-pulmonary infectious complications, need for a new postoperative ICU admission, mean hospital length of stay, 30-day mechanical ventilation free-days and 30-day organ dysfunction free days. The number and types of surgeries on all patients during the observed period will be reported. The number of surgeries performed during the year before and the mean time of room usage and cleaning in all patients of both observation periods will also be reported.

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