Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)

Study Overview
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Brief Summary
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CovidSurg will capture real-world international data, to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. This shared international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, ultimately improving their clinical care.

Detailed Description
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There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery. Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care. The primary aim of the study is to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. In doing so, this will inform future risk stratification, decision making, and patient consent. CovidSurg is an 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.

Official Title
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Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)

Conditions
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COVID-19, Coronavirus, Surgery

Intervention / Treatment
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* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing ANY type of surgery in an operating theatre, this includes obstetrics AND - The patient had COVID-19 infection either at the time of surgery or within 30 days of surgery, based on (i) positive COVID-19 lab test or computed tomography (CT) chest scan OR (ii) clinical diagnosis (no COVID-19 lab test or CT chest performed) Exclusion Criteria: If COVID-19 infection is diagnosed >30 days after discharge, the patient should not be included.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Patients with COVID-19 infection undergoing surgery | Procedure: Surgery<br>* Emergency or elective surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | Death up to 30-days post surgery | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day mortality | Death up to 7-days post surgery | 7 days post surgery | 
| 30-day reoperation | Reoperation up to 30-days post surgery | Up to 30-days post surgery | 
| Postoperative ICU admission | Admission to ICU post surgery | Up to 30 days post surgery | 
| Postoperative respiratory failure | Respiratory failure post surgery | Up to 30 days post surgery | 
| Postoperative acute respiratory distress syndrome (ARDS) | Acute respiratory distress syndrome post surgery | Up to 30 days post surgery | 
| Postoperative sepsis | Sepsis post surgery | Up to 30 days post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Coronavirus, Surgery