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

Covid-19 Clinical Trial

— SUROCO  

Official title:

SURgical Outcomes in COvid Patients - the SUROCO Multicenter Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04458337
• Other study ID #: 19.386
• Status: Completed
• Start date: March 13, 2020
• Est. completion date: April 13, 2022

Study information

• Verified date: September 2021
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: April 13, 2022
• Est. primary completion date: March 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• Postoperative Complications
• SARS-CoV2
• Surgery
• Surgical Procedure; Complications, Late Effect of Complications

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec

Sponsors (9)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Centre de recherche du Centre hospitalier universitaire de Sherbrooke, CHU de Quebec-Universite Laval, Hopital du Sacre-Coeur de Montreal, Hôpital Maisonneuve-Rosemont, Institut de Cardiologie de Montréal, Institut universitaire de cardiologie et de pneumologie de Québec, McGill University Health Centre/Research Institute of the McGill University Health Centre, St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital survival	Survival was calculated from the date of participant randomization to the date of participant death due to any cause. 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.	30 days post-operation
Secondary	Occurrence of postoperative respiratory complications	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.	30 days post-operation
Secondary	Occurrence of postoperative non-pulmonary infectious complications	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.	30 days post-operation
Secondary	Occurrence of acute kidney injury (AKI)	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.	30 days post-operation
Secondary	Occurrence of postoperative thromboembolic complications	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).	30 days post-operation
Secondary	The need for a new postoperative ICU admission	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.	30 days post-operation
Secondary	Hospital length of stay	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.	An average of 7 days
Secondary	30-day mechanical ventilation free-days	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.	30 days post-operation
Secondary	30-day organ dysfunction free days	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.	30 days post-operation
Secondary	Surgical reinterventions	Any surgical reintervention in the operating room either related or unrelated to the initial intervention was recorded.	30 days post-operation
Secondary	Any ICU admission during the index hospital stay	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.	30 days post-operation
Secondary	30-day survival	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.	30 days post-operation
Secondary	6-month survival	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.	6 months post-operation