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

• Conditions: Surgery; COVID-19; Coronavirus
• Interventions: Procedure: Surgery

• Registration Number: NCT04323644
• Lead Sponsor: University of Birmingham

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-26
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-12
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Surgery	Patients with COVID-19 infection undergoing surgery

Primary Outcome Measures

Name	Time	Method
30-day mortality	30 days	Death up to 30-days post surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital del Henares; 🇪🇸 Madrid, Spain