Clinical trial NCT04323644: Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)
Official title: Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Coronavirus
Surgery
Keywords: COVID-19
Coronavirus
Surgery
Lead sponsor: University of Birmingham
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COVID-19 infection who undergo surgery

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: 7-day mortality
timeFrame: 7 days post surgery
measure: 30-day reoperation
timeFrame: Up to 30-days post surgery
measure: Postoperative ICU admission
timeFrame: Up to 30 days post surgery
measure: Postoperative respiratory failure
timeFrame: Up to 30 days post surgery
measure: Postoperative acute respiratory distress syndrome (ARDS)
timeFrame: Up to 30 days post surgery
measure: Postoperative sepsis
timeFrame: Up to 30 days post surgery
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital del Henares
Study officials:
References:
citation: COVIDSurg Collaborative. Outcomes after perioperative SARS-CoV-2 infection in patients with proximal femoral fractures: an international cohort study. BMJ Open. 2021 Nov 30;11(11):e050830. doi: 10.1136/bmjopen-2021-050830.
citation: Seeliger B, Philouze G, Cherkaoui Z, Felli E, Mutter D, Pessaux P. Acute abdomen in patients with SARS-CoV-2 infection or co-infection. Langenbecks Arch Surg. 2020 Sep;405(6):861-866. doi: 10.1007/s00423-020-01948-2. Epub 2020 Jul 27.