Clinical trial NCT04458337: SURgical Outcomes in COvid Patients - the SUROCO Multicenter Cohort Study (COVID-19)
Official title: SURgical Outcomes in COvid Patients - the SUROCO Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
SARS-CoV2
Surgery
Surgical Procedure; Complications, Late Effect of Complications
Postoperative Complications
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Maisonneuve-Rosemont Hospital
name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Hopital du Sacre-Coeur de Montreal
name: St. Justine's Hospital
name: Institut de Cardiologie de Montréal
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: CHU de Quebec-Universite Laval
name: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
First posted: 2020-07-07
Enrollment: 318
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients (children and adults) confirmed being infected to SARS-CoV-2 will be included, as well as patients who have recovered, undergoing a surgical procedure in designated Canadian Centers. The investigators will include all patients up to 30th day of April 2021.

Brief 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, as well as in those who have recovered from COVID-19.

Detailed 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 healed from COVID-19 and measure the association between time from first positive test and postoperative outcomes.

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

Exposure variables:

For the primary objective, the exposure of interest will be the presence of symptoms at time of surgery. For the secondary objective, the exposure will be the length of time between first COVID-19 positive test and the date of surgery. For the tertiary objective, the status of the disease will be our exposure of interest.

Variable definitions:

All COVID-19 variables will be based on 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.Criteria for "healed" status changed in November 2020 and were less restrictive (as detailed in table 1 of the protocol). No minimal or maximal delay will be applied between SARS-COV-2 infection and surgery for inclusion.

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 24 hours (emergent or urgent), or 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 using regular hospital follow-up. 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.

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:

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 at the time of surgery (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. . To evaluate if presence of symptoms is associated with hospital survival in SARS-COV2 infected patients for the primary analysis, investigators will fit a multivariable Cox model that will include presence of symptoms, preoperative hospitalization, 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. If too few events our observed, 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 first positive test (categorized as 0-4 weeks, 4-8 weeks and \> 8 weeks). The investigators will report the same outcomes as previously mentioned. To analyze the effect of recovery time on postoperative survival, the investigators will fit a similar multivariable survival model . The investigators will include time since first positive COVID-19 test, preoperative hospitalization, 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. Investigators will explore non-linear relationship between time and the outcome.

Tertiary objective The investigators will report descriptively patients who have recovered and asymptomatic COVID-19 patients. To compare if those two groups of patients are different regarding hospital survival, the investigators will fit a multivariable survival model that will include status (recovered versus asymptomatic carrier), preoperative hospitalization, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital survival
timeFrame: 30 days post-operation
Secondary outcomes:
measure: Occurrence of postoperative respiratory complications
timeFrame: 30 days post-operation
measure: Occurrence of postoperative non-pulmonary infectious complications
timeFrame: 30 days post-operation
measure: Occurrence of acute kidney injury (AKI)
timeFrame: 30 days post-operation
measure: Occurrence of postoperative thromboembolic complications
timeFrame: 30 days post-operation
measure: The need for a new postoperative ICU admission
timeFrame: 30 days post-operation
measure: Hospital length of stay
timeFrame: An average of 7 days
measure: 30-day mechanical ventilation free-days
timeFrame: 30 days post-operation
measure: 30-day organ dysfunction free days
timeFrame: 30 days post-operation
measure: Surgical reinterventions
timeFrame: 30 days post-operation
measure: Any ICU admission during the index hospital stay
timeFrame: 30 days post-operation
measure: 30-day survival
timeFrame: 30 days post-operation
measure: 6-month survival
timeFrame: 6 months post-operation
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: François-Martin Carrier, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrier FM, Amzallag E, Lecluyse V, Cote G, Couture EJ, D'Aragon F, Kandelman S, Turgeon AF, Deschamps A, Nitulescu R, Djade CD, Girard M, Beaulieu P, Richebe P. Postoperative outcomes in surgical COVID-19 patients: a multicenter cohort study. BMC Anesthesiol. 2021 Jan 12;21(1):15. doi: 10.1186/s12871-021-01233-9.