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

COVID-19 Clinical Trial

— CovidSurg  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04323644
• Other study ID #: CS-20200324
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: May 2020
• Source: University of Birmingham
• Contact: Aneel Bhangu
• Phone: +44 1216272949
• Email: A.A.Bhangu[@]bham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID-19
• Surgery

Intervention

Procedure:
• Surgery
Emergency or elective surgery

Locations

Country	Name	City	State
Spain	Hospital del Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Birmingham

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	Death up to 30-days post surgery	30 days
Secondary	7-day mortality	Death up to 7-days post surgery	7 days post surgery
Secondary	30-day reoperation	Reoperation up to 30-days post surgery	Up to 30-days post surgery
Secondary	Postoperative ICU admission	Admission to ICU post surgery	Up to 30 days post surgery
Secondary	Postoperative respiratory failure	Respiratory failure post surgery	Up to 30 days post surgery
Secondary	Postoperative acute respiratory distress syndrome (ARDS)	Acute respiratory distress syndrome post surgery	Up to 30 days post surgery
Secondary	Postoperative sepsis	Sepsis post surgery	Up to 30 days post surgery