Invite to join the CovidSurg-BreastCancer study
Outcomes of elective cancer surgery during the COVID-19 pandemic crisis: an international, multicentre, observational cohort study (CovidSurg-BreastCancer)
The rapid emergence of the COVID-19 virus has led to a global impact on elective surgical care. We have very little evidence to guide us. The magnitude and effects of these changes are uncertain. The safety of operating on patients electively with the risks of COVID-19 postoperative pneumonia is unknown. High-quality data will allow policy planning at regional and hospital level for both this outbreak and future pandemics. CovidSurg-Breast Cancer will run in parallel to CovidSurg (which is capturing outcomes of patients undergoing surgery for all indications with concurrent COVID-19).
In order to contribute to CovidSurg-Breast Cancer you must first secure appropriate approvals and senior surgeon leadership, according to local regulations. You can get approval from the audit department or as per protocol in your hospital (GDPR compliance to be followed).
This short protocol has been written to support that process. This investigator-led, non-commercial, non-interventional study is extremely low to zero risk. This study does not collect any patient identifiable information and data will not be analysed at hospital-level.
Any centre that performs elective breast cancer surgery and has been affected by COVID-19 is eligible for participation. This study be performed prospectively, retrospectively or using a mixed model, dependent on the phase of COVID-19 infection in your hospital.
Dr Raghavan Vidya,
Honorary senior Lecturer Birmingham university,
Consultant oncoplastic Breast Surgeon, Royal Wolverhampton NHS Trust, UK
Mr Aneel Bhangu,
MBChB PhD FRCS
Consultant Surgeon, University Hospital Birmingham, UK
The key steps to register for the study are:
- Register your site’s interest at here
- An email will follow within 24h with a link to complete for the REDCap log-ins and key study documentations
- Review the study protocol and CRFs at globalsurg.org/cancercovidsurg
- Gain necessary local approvals; in the UK this has been classified as clinical audit and a supporting letter from an NHS ethics committee and the RCS England is attached here. Examples for REC/IRB approvals from other countries are available at globalsurg.org/covidsurg
- If another investigator from your site already has local approval you do not need to gain this again specifically for Breast Cancer as the approvals cover all operated cancer types – our team will connect you to other users from your centre.
- You’re ready to start data collection!