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

  • STATUS
    Recruiting
  • End date
    Apr 13, 2022
  • participants needed
    226
  • sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
Updated on 29 September 2021
fever
mechanical ventilation
fatigue
myalgia
dyspnea
respiratory failure
covid-19
SARS
vomiting
cough

Summary

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 seem to be variable. Expected benefits from a surgical procedure may be different in this population if their postoperative mortality is higher than expected. The association between preoperative characteristics and postoperative outcomes in this population has to be better defined.

There is a need to better quantify these and better inform use of surgical resources during 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

METHODS Objectives

Primary: To describe postoperative outcomes in patients with COVID-19 undergoing a surgical procedure and measure the association between presence of symptoms and postoperative outcomes.

Secondary: To describe postoperative outcomes in patients undergoing a surgical procedure after they have recovered from COVID-19 and measure the association between time from last positive test and postoperative outcomes.

Tertiary: To compare outcomes between asymptomatic COVID-19 patients undergoing a surgery with those who have recovered from it.

Exposure variables:

To answer the primary 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, 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, the surgical disease that brought the patient to the operating room, its urgent nature and invasiness, and intraoperative variables (type of anesthesia, type of intubation technique, blood loss, fluid balance, transfusions, duration of surgery).

To answer the secondary objective, the investigators will also collect similar data as well as the length of time between COVID-19 positive test and the date of surgery. The investigators will categorize the time since last positive test in three categories: 0-4 weeks, 4-8 weeks and more than 8 weeks.

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 as having two negative SARS-CoV-2 PCR tests between the last positive one and the surgery, or 1 negative test and a clinically significant period without symptoms between the last positive test and the negative one or no negative test but considered as recovered by the clinical team because of complete symptoms resolution.

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 hospital survival. The investigators will also capture survival up to 30 days and 6 months. 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.

Analyses

The investigators will describe the population of patients undergoing a surgery while having COVID-19 and those who had recovered from it.

Primary objective The investigaors will first conduct descriptive analyses of baseline characteristics and outcomes of COVID-19 confirmed patients based on the presence of symptoms (symptomatic versus asymptomatic). The investigators will report descriptively the following outcomes in both patients' population: 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 primary analysis will be a multivariable model on postoperative hospital survival of these patients. A multivariable Cox model that will include presence of symptoms, preoperative respiratory support need (invasive mechanical ventilation, oxygen therapy, no oxygen), urgency of surgery, importance of surgery (major versus minor) as independent variables and a frailty factor as a center random effect will be fitted. If too few events our observed, the investigators will limit covariables in their model.

Secondary objective The investigators will report descriptively patients who have recovered by categorizing them based on the time since last positive test. The investigators will report the same outcomes as previously mentioned. The investigators will fit a similar multivariable survival model . The investigators will include time since last positive COVID-19 test (categorized as 0-4 weeks, 4-8 weeks and > 8 weeks), preoperative respiratory support need (invasive mechanical ventilation, oxygen therapy, no oxygen), urgency of surgery, importance of surgery (major versus minor) as independent variables and a frailty factor as a center random effect.

Tertiary objective The investigators will report descriptively patients who have recovered by categorizing them based on the time since last positive test and asymptomatic COVID-19 patients. The investigators will fit a multivariable survival model that will include status (recovered versus asymptomatic carrier), preoperative respiratory support need (invasive mechanical ventilation, oxygen therapy, no oxygen), urgency of surgery, importance of surgery (major versus minor) as independent variables and a frailty factor as a center random effect.

Details
Condition Surgery, Postoperative Complication, Surgical aspects, Surgery, *COVID-19, Covid-19, SARS-CoV2, Surgical Procedure; Complications, Late Effect of Complications, SARS-CoV2, Surgical Procedure; Complications, Late Effect of Complications, SARS-CoV2, Surgical Procedure; Complications, Late Effect of Complications, SARS-CoV2, Surgical Procedure; Complications, Late Effect of Complications, SARS-CoV2, Surgical Procedure; Complications, Late Effect of Complications, postoperative complications, postoperative problems, surgical procedures, surgical treatment, surgeries, surgical procedure, SARS-CoV2, Surgical Procedure; Complications, Late Effect of Complications, SARS-CoV2, Surgical Procedure; Complications, Late Effect of Complications, SARS COV2, Surgical Procedure; Complications, Late Effect of Complications, Surgical Procedure; Complications, Late Effect of Complications, Surgical Procedure; Complications, Late Effect of Complications, Surgical Procedure; Complications, Late Effect of Complications, Surgical Procedure; Complications, Late Effect of Complications
Clinical Study IdentifierNCT04458337
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Last Modified on29 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

all patients undergoing a surgery with either a SARS-CoV-2 clinical suspicion based on reported symptoms during the pandemic (fever, myalgia, fatigue, cough, dyspnea, respiratory failure, diarrhea, vomiting, abdominal pain) or without any suggestive symptoms AND a SARS-CoV-2 confirmed infection with RT-PCR before surgery or within 72 hours after surgery. Patients who have recovered from SARS-CoV-2 infection will also be included. All patients up to 30th day of April 2021 will be included

Exclusion Criteria

none
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