CovidSurg Cohort Study

/CovidSurg Cohort Study
CovidSurg Cohort Study 2020-03-30T23:44:42+00:00

About CovidSurg Cohort Study

Patients diagnosed with COVID-19 infection who need surgery are a challenging group. Capturing real-world data and sharing international experience about the management of surgical patients during this pandemic will inform clinical decision making. CovidSurg Cohort Study is an international multi-centric cohort study aiming to assess the outcomes of surgery in patients with COVID-19 infection.

Patients meeting the following inclusion criteria can be included in CovidSurg:

  • Patients undergoing ANY type of surgery in an operating theatre, this includes obstetrics.

          AND

  • Either before or after surgery: (i) lab test confirmed COVID-19 infection or (ii) clinical diagnosis of COVID-19 infection (no test performed).

Highlights of CovidSurg Cohort Study

  • Any hospital can participate. Some hospitals might currently have few cases while others might have a lot. Every hospital treating or expecting to treat surgical patients with COVID-19 infection is welcome.

  • Patients can be included in this study if they undergo any type of surgery and have a COVID-19 diagnosis (by lab test or clinical), in the pre or post-operative period.

  • The primary outcome is mortality at 30 days after surgery. Secondary outcomes will be other surgical and medical complications.

  • There is no fixed data collection period and patients can be included either prospectively or retrospectively.

  • Data will be stored in a secure online platform (REDCap). Only anonymised data will be collected.

  • All the collaborators will be recognised as co-authors in any publications resulting from this study.  A corporate authorship model will be used under CovidSurg Collaborative group, for example: https://pubmed.ncbi.nlm.nih.gov/29452941

Setting up your site to participate in CovidSurg Cohort Study

  • To get involved, please first complete the registration form.

  • Ensuring local approvals to participate is the most important next step.

  • You will get an email from our team and your hospital will be issued a REDCap login. If your hospital is already signed up for the study, you will be out in contact with your colleagues to build a team.

  • If you wish to start data collection on paper and upload it later, please use the data collection sheet below.

  • Contacts for each country are available in our network page so you can have support from your colleagues.

  • For any queries please contact [email protected]

Register for COVIDSurg
Country specific contacts
Download protocol
Data collection sheet

General documents

In order to facilitate communication with patients and local approvals, we have designed:

  • Patient Information Sheet and an Informed Consent template. You are free to use it or adapt it, according to local requirements.

  • A support/invitation letter from the study coordinator. Some ethics committees may require this. You might also use this as a facilitator to talk about the study to your Head of Department.

  • A letter about the online secure data storage platform – REDCap. Some ethics committees require detailed information about it.

  • An example of a CovidSurg poster designed to be affixed in the operating theatre. The aim is to let all surgical teams know about the study and maximise patient inclusion. It can be used as a template for your own hospital.

  • A link sheet if you wish to have a document cross-referencing the hospital nr and REDCap ID. This can be useful to track patients records to collect follow-up data. You should keep this file in a secure place in your hospital.

Country specific CovidSurg documents

In order to contribute to CovidSurg you must first secure research/audit approval, according to local regulations.  The global community has recognised that rapid dissemination and completion of studies in COVID-19 infected patients is a high priority, so we encourage all stakeholders (local investigators, ethics committees, IRBs) to work as quickly as possible to approve this project. Please discuss with your head of department to identify the quickest way to secure study approval. If you would like to collect data whilst awaiting formal study approval, please find below a data collection sheet. Once the study is approved, you can upload the data to the online REDCap database. Please find below previous approvals and application templates you can use to facilitate your own.

Australia

Germany

Italy

Portugal

Spain

UK

USA

CovidSurg Homepage
Countries registered to take part in GlobalSurg II

Is your country represented on the map? Scroll around the map to see if your country is represented. If not, we'd love to hear from you! Get in touch with us via our registration form or contacts page