Welcome To COVIDSurg3

A new study on the outcomes of patients with perioperative SARS-CoV-2 infection

during the vaccination and Omicron era

COVIDSurg3 is an international prospective cohort study aiming to:

(1) Determine 30-day mortality in patients with peri-operative SARS-CoV-2 infection

(2) Inform future risk stratification, decision making and patient consent

ANY hospital can participate

ALL collaborators will be included as PubMed-citable co-authors on resulting publications

Hospitals can participate in the patient-level component, the hospital-level component, or ideally both

Patient-level component

OBJECTIVE

Assess the outcomes of patients with peri-operative SARS-CoV-2 and evaluate implementation of SARS-CoV-2 adaptations.

INCLUSION CRITERIA

  • Surgery performed by a surgeon in an operating theatre AND
  • A positive SARS-CoV-2 PCR swab or rapid antigen test within 7 days before or 30 days after surgery

WHEN?

All eligible patients across all specialties should be captured for at least 4 weeks between 13 December 2021 to 28 February 2022

TEAM STRUCTURE

  • 1 hospital lead (for both components)
  • Up to 5 total collaborators to collect data

Hospital-level component

OBJECTIVE

Determine the frequency of perioperative SARS-CoV-2 infection and same-day elective cancellations

INCLUSION CRITERIA

  • Any hospital can participate, regardless of taking part in the patient level component.
  • Data collection must be mapped to one or more of the pre-defined body regions specified in the protocol.

WHEN?

All elective and emergency surgical activity relating to the selected body region(s) should be captured during one or more of the 14 day blocks.

TEAM STRUCTURE

  • 1 hospital lead (for both components)
  • One collaborator per 14-day block, collecting data for one or more specialities
  • Maximum of 4 collaborators per body region

COVIDSurg3 documents

Study protocol
Patient-level component data sheet
Hospital-level component data sheet
Protocol appendix
REDCap guide
Patient cross list

How to participate

  1. Check if your hospital has a hospital lead here
    • If there is a hospital lead, please contact them to take part.
    • If there is no hospital lead and you are interested in taking that role, please contact the national lead.
  2. Obtain study approval
    • If you have participated in previous COVIDSurg studies, check if you can have an extension of the previous approval.
    • If not, please submit your study application as soon as possible (documents above)
  3. Set up your team and get it registered through the hospital lead
  4. Start identifying patients
    • If your local regulations allow, you can start collecting data on paper while awaiting formal approval

COVIDSurg3 FAQs

Registration and REDCap

Check if your hospital has a hospital lead here

    • If there is a hospital lead, please contact them to get registered
    • If there is no hospital lead and you are interested in taking that role, please contact the national lead

Only one REDCap account will be issued per hospital. Please contact your hospital lead to gain access.

If you are the hospital lead, please contact the national lead to get registered and be issued your local login.

In this project, one login will be issued to the hospital lead.

Authorship information will be collected at the end of the study.

You can contact [email protected]com. Our team will be able to confirm your username and arrange a password re-set for you.

Documents and information for approvals

Mr Aneel Bhangu

Senior Clinical Lecturer in Global Surgery | NIHR Unit on Global Surgery

Institute of Translational Medicine, University of Birmingham, Edgbaston, Birmingham, UK, B15 2TH
Tel: +44 (0) 121 3718121

Carolyn Pike OBE, Director of Legal Services

University of Birmingham, Edgbaston, Birmingham B15 2TT
Tel: 0121 414 3916
Email: [email protected]

Yes, please find above a letter of support under study documents.

Please do contact your National Lead of [email protected] if you need other documents.

Collaborators and authorship

One hospital lead should be appointed and will be the same for both study components.

Patient-level component

  • Up to 4 additional collaborators (for a total of 5, including the hospital lead) should collect data across all specialities.

Hospital-level component

  • One collaborator can participate per 14-day block, collecting data from one or more selected body regions.
  • Up to 4 collaborators can participate per body region.
  • Data collection MUST be mapped to our pre-defined body regions & collaborator should capture ALL elective + emergency surgical activity relating to that body region, even if it is split between different specialties.
  • In small hospitals it may be appropriate for a single collaborator to capture data for all patients being operated in the hospital.

Yes – the hospital lead in each hospital will have the responsibility to fill a form for each collaborator with their details and role.

For each paper, we will include the members of the team who contributed to data collection for the patients included in that particular paper. (For example, for a paper using only the patient-level component data, only the collaborators who contributed to the patient-level component will be included.)

The hospital lead (HL) should coordinate both the patient-level and hospital-level components (if participating in both).

Patient-level component responsibilities:

  • Set up a team (max 4 other people) to capture all eligible patients at their hospital across all specialties.
  • A REDCap login will only be issued to the HL, so they should ensure all data is entered on to REDCap.
  • At the end of the study the HL will need to submit authorship details for other team members.

Hospital-level component responsibilities:

  • Recruit collaborators to collect case-mix data, ensuring there is no overlap in data collection between collaborators.

YES, a resident/trainee/registrar can assume the role of the hospital lead.

The hospital lead is required to take responsibility for study conduct and Clinical Governance departments. A consultant might be required or best placed to do this but we allow trainees/residents to take this role when locally appropriate.

Yes – other professionals contributing to the study at your site can be registered and recognised.

We recommend that consultant/attending physicians or trainees act as hospital leads. Medical students are very welcome to help collect data where appropriate but are not best placed to lead a local team. If further questions please contact us through [email protected]

Inclusion criteria

You should include patients diagnosed with SARS-CoV-2 infection within 7 days before or 30 days after surgery (via PCR or rapid antigen test).

Do not include patients if:

  • Their SARS-CoV-2 infection was diagnosed more than 7 days before surgery (regardless of their symptomatic status at the time of surgery) or beyond 30 days after surgery
  • A SARS-CoV-2 infection was suspected based on clinical signs or radiology, but not confirmed by a PCR test or rapid antigen test
  • Patients who have had a positive rapid antigen test followed by a negative confirmatory PCR test should be excluded

Patients with a negative test should be excluded from the patient-level component. Even if they have clinical symptoms which could be COVID, a positive PCR or rapid antigen test (if PCR swab is not available) is the inclusion criteria.

Patients undergoing a procedure performed by a surgeon in an operating theatre should be included, unless undergoing only minor procedures listed in the protocol appendix, in which case they should be excluded.

All surgical specialties are included. Patients can be included regardless of surgical indication (benign surgery, cancer surgery, trauma, obstetric), anaesthetic type (local, regional, general), surgical approach (minimally invasive surgery, open surgery), or whether it is day-case or inpatient surgery.

Data: consent, collection, access and analysis

You must follow all applicable ethical requirements at your hospital.

For example: in the United Kingdom, CovidSurg3 is being registered as audit or service evaluation, this means that patient consent is not required. However, in some countries patient consent (written or verbal) may be required, please liaise with local approval committees for more information.

It might we worth noting to your ethical committee that only routinely collected and fully anonymised data is uploaded. Not even specific operation dates are uploaded.

Yes – you can find template Patient Information Sheets and Informed Consents forms above, under study documents.

Patient-level component:
• COVIDSurg3 is an extension of previous CovidSurg projects.
• If a hospital participated in CovidSurg-1/ SurgWeek, we suggest that the team approach their ethics committee/IRB to explore whether this extension can be
run as an amendment to the previous approval, or alternatively have expedited approval.
• Hospital-level component:
• If participating in the patient-level component, we suggest that the hospital-level component is included within the overall ethics submission/ approval.
• If NOT participating in the patient-level component, we suggest to explore whether the need for study approval can be waived, since only anonymized, aggregated (administrative) data will be collected

Study approval must be cofirmed before ANY data is uploaded to the REDCap database.

The overall patient inclusion period is 13 December 2021 to 28 February 2022. Patients can be included if they were operated between these dates (inclusive).

For the patient-level component, at least 4 weeks of consecutive data collection must occur. Therefore, if taking this approach, data collection must start on 1 February 2022 or earlier.

For the hospital-level component collaborators should collect data during one or more 14-day blocks.

30-day follow-up data should be collected from the date of the index operation.

As this is an observational study NO changes should be made to normal patient pathways. Therefore, no additional patient follow-up should be completed for this study beyond what is normal practice at the hospital. Follow-up data can be collected at 30-days based on written patient notes, computer records, or telephone or in-person follow-up (if patients are normally followed-up at 30-days at the hospital).

Yes. Some hospitals will have treated many SARS-CoV-2 patients during their local ‘Omicron wave’ before study approvals are granted. It is important to capture their experience, so retrospective patient identification and data entry is permitted. E.g. if study approval is granted on 7 February 2022, they could retrospectively enrol patients operated on 13 December 2021 to 6 February 2022, and then prospectively enrol patients operated on 7 February 2022 to 28 February 2022.

If permitted, prior to formal local study approval, collaborators prospectively collect data on hard copy case report forms. However, no data should be uploaded to the REDCap database before study approval is confirmed.

There is no expectation for patients to undergo any extra tests. Please just complete all data points that are routinely available. Our data management team will ask you to confirm this before the dataset is locked for analysis.

Patient-level component

  • All consecutive patients fulfilling inclusion criteria across all specialties should be captured.
  • Individual participating centres can apply an age cut-off to the inclusion criteria (e.g. to include children only, adults only, or both children and adults).

Hospital-level component

  • All patients undergoing surgery for one or more body regions should be captured over consecutive 14-day blocks.

Each patient that is entered onto REDCap will automatically generate a REDCap ID number. You will need to keep a record of which patient has which REDCap ID number using a link sheet, this should be done locally and kept safe. We cannot know or record this information as the patient would be identifiable to us.

Country contacts

Yes – we have a Disseminations Committee, where several enthusiastic colleagues agreed to act as country contacts for CovidSurg. They can support you through the setup process at your hospital.

Please visit https://globalsurg.org/covidsurg-network/ to contact your country lead, if required.

You can contact the CovidSurg steering committee through [email protected]

If you wish to disseminate information about the studies in your country and help further sites to enrol, please contacts us through [email protected] We acknowledge this is a demanding task and we will recognise active country contacts as co-authors in our corporative co-authorship.