COVIDSurg: An International Study to Quickly Improve COVID-19 Surgical Outcomes

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An international cohort of surgeons, working as a rapid response research collaborative, has mobilized to collect real-world data as a way to inform surgical practices, policies and outcomes for patients infected with COVID-19. This study, called COVIDSurg, is spearheaded by a research team from the University of Birmingham in the United Kingdom and the Massachusetts General Hospital Department of Surgery.

"The goal at the launch of this project was to share knowledge as early on as possible during the pandemic so that we all learn from it," says U.S. study lead, Haytham Kaafarani, MD, MPH, trauma surgeon, director of the Mass General Center for Outcomes & Patient Safety in Surgery (COMPASS) and director of the Trauma Research Laboratory. "The feeling among health care workers right now is a sense of urgency and that we have a duty to save the sickest of the sick. This data will help us treat our patients better and give them the best care we can."

The Launch of COVIDSurg

COVID-19 is known to be a systemic disease with severe manifestations. Patients show signs of hypercoagulation (extreme clotting of the blood) and even gastrointestinal indicators, such as ileus (paralysis of the intestines). In conjunction with the clots, these complications can result in an increased risk of stroke, ischemia and more. When there is increased severity, surgical intervention may be required.

Based on those learnings, it became apparent quickly that knowledge of the surgical implications of COVID-19 is immediately critical to patient care.

"If the patient has COVID-19 and their outcomes are worse, the data might show that the second-best alternative, such as antibiotic treatment, is the better approach," says Dr. Kaafarani. "It can alter how we manage surgical patients with the disease. In addition, early data is suggesting that COVID-19 might have peculiar manifestations, such as bowel ischemia, warranting surgical intervention."

Data is being collected quickly and in high quantities from around the world through the collaborative's website. Within 10 days, COVIDSurg collected more than 4,000 registrations from 121 countries as well as hundreds of patients' data—400 from the Mass General surgery team.

Though the disease is not surgical in nature, data on this complex patient group is imperative to identify:

1. Any increased risks of surgical operations on patients who have tested positive for COVID-19
2. If non-surgical treatment is an option or even the better approach, in both elective and emergent surgery

Additionally, if a COVID-19 patient does require surgery for a complication unrelated to the virus, the group wanted to know: are they at higher risk of not doing well?

COVID-19 can cause a cytokine storm (a hyperinflammatory state), but it remains unclear if this leads to a higher risk of incurring complications from surgery or even an increased mortality rate.

"Knowing the odds will help us better counsel the patient's family and set expectations, especially during the early and tail ends of the pandemic," says Dr. Kaafarani.

Those interested in participating in the study must register through the Institutional Review Board (IRB). Pending approval and adherence to the study's guidelines—which involves specific inclusion and exclusion criteria—participants can then upload patient data through the COVIDSurg website to a secure multicenter database. The study protocol and criteria consider a patient's demographic, medical history, type of surgery (i.e., elective vs. emergency), recovery and any pre-existing conditions.

Only two groups in the world have access to the international pool of data: the University of Birmingham and Mass General.

"Egos were left at the door. Everyone is coming together with the patient and the need for patient data in mind," says Dr. Kaafarani. "There will not be an individual name listed on the publication(s). Once the data is analyzed, it will be published under the name COVIDSurg Collaborative."

Moving Through Hurdles for Impactful, Large-scale Collaboration

The IRB approval process generally takes months, but when the team submitted their application with an explanation of the project's premise and goals on a Sunday morning, they were approved by that afternoon.

"It typically takes moving mountains to do a collaboration between multiple hospitals because of logistical hurdles," says Dr. Kaafarani. "It is absolutely amazing that 4,000 surgeon-scientists from across the world have come together with the study protocol, agreements and momentum—and in less than 10 days have rapidly contributed data."

The primary tools for promoting the initiative and mobilizing those involved are anything but customary: social media and WhatsApp.

This experience has set a precedent that when there is a will and a need, the community has the ability to do collaborations on a much larger scale and can mobilize on a global level faster via immediate communication tactics.

"The one thing at the center of all of this is the patient," says Dr. Kaafarani. "The patients come first and this data will empower us to take better care of them."

View all COVID-19 updates

Learn more about the COVIDSurg study