Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg) (CovidSurg)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04323644|
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : May 12, 2020
|Condition or disease||Intervention/treatment|
|COVID-19 Coronavirus Surgery||Procedure: Surgery|
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 Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Patients with COVID-19 infection undergoing surgery
Emergency or elective surgery
- 30-day mortality [ Time Frame: 30 days ]Death up to 30-days post surgery
- 7-day mortality [ Time Frame: 7 days post surgery ]Death up to 7-days post surgery
- 30-day reoperation [ Time Frame: Up to 30-days post surgery ]Reoperation up to 30-days post surgery
- Postoperative ICU admission [ Time Frame: Up to 30 days post surgery ]Admission to ICU post surgery
- Postoperative respiratory failure [ Time Frame: Up to 30 days post surgery ]Respiratory failure post surgery
- Postoperative acute respiratory distress syndrome (ARDS) [ Time Frame: Up to 30 days post surgery ]Acute respiratory distress syndrome post surgery
- Postoperative sepsis [ Time Frame: Up to 30 days post surgery ]Sepsis post surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323644
|Contact: Aneel Bhangu||+44 1216272949||A.A.Bhangu@bham.ac.uk|
|Contact: Dmitri Nepogodiev||+44 1216272949||D.Nepogodiev@bham.ac.uk|
|Hospital del Henares||Recruiting|
|Contact: Ana Minaya-Bravo Anafirstname.lastname@example.org|
|Principal Investigator: Ana Minaya-Bravo|