Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
2000 participants
OBSERVATIONAL
2021-12-13
2022-03-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
CovidSurg-3 is an extension to CovidSurg and was initiated in response to the emergence of the Omicron variant.
CovidSurg-3 has two separate components:
* Patient-level component: Collection of outcome data for patients with peri-operative SARS-CoV-2.
* Hospital-level component: Collection of aggregated case-mix data. Hospitals in countries with low community SARS-CoV-2 infection rates can contribute towards this component.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
During the first COVID-19 wave, over 28 million elective operations worldwide were either cancelled or delayed9. This enabled redistribution of staff and resources to meet COVID-19 demand, but resulted in substantial treatment delays, including for cancer patients10-11. COVID-19 lockdowns were associated with one in seven patients awaiting cancer surgery not being operated, and those patients who were operated experienced delays10.
In 2020 CovidSurg captured outcomes on over 190,000 patients across \>2,000 hospitals in 116 countries. This resulted in data-driven guidance for surgical systems during the pandemic, including:
* Guidance regarding the optimal delay prior to surgery following SARS-CoV-2 infection4.
* The establishment of COVID-19-free surgical pathways to reduce nosocomial infection and complication2.
* The non-effectiveness avoidance of preoperative isolation12.
* Optimal preoperative SARS-CoV-2 screening protocols13.
* Potential benefits of preoperative vaccination14.
The Omicron SARS-CoV-2 variant of concern was first reported on 25 November 2021 and has spread globally rapidly15. There is a high-level of evidence indicating Omicron has increased transmissibility and potential to evade immunity16-18. However, there is little robust evidence regarding disease severity associated with Omicron in both vaccinated and unvaccinated patients (including in surgical patients), nor is there data to guide patient risk stratification during Omicron COVID-19 waves18.
COVID-19 has significant detrimental impacts on surgical systems and patient outcomes. CovidSurg has provided the best available evidence to guide delivery of safe surgery during the pandemic. However, CovidSurg data were collected in 2020 when the wildtype SARS-CoV-2 virus was dominant, and therefore there is a need to for renewed rapid data to guide global practice during Omicron COVID-19 waves.
The primary objective is to determine 30-day mortality in patients with peri-operative SARS-CoV-2 infection. This will inform future risk stratification, decision making, and patient consent.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control (normal practice)
Patients that underwent surgery (across all specialities), performed by a surgeon in an operating theatre, AND had a positive SARS-CoV-2 PCR swab or rapid antigen test (if PCR swab is not available) within 7 days before or 30 days after surgery. Patients can be included regardless of whether a specific variant is suspected or unknown
Surgery (across all specialities)
Surgery performed by a surgeon in an operating theatre during the patient inclusion period
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Surgery (across all specialities)
Surgery performed by a surgeon in an operating theatre during the patient inclusion period
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* They had a positive SARS-CoV-2 PCR swab or rapid antigen test (if PCR swab is not available) within 7 days before or 30 days after surgery. Patients can be included regardless of whether a specific variant is suspected or unknown
Exclusion Criteria
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Birmingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aneel Bhangu
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Birmingham
Birmingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Dmitri Nepogodiev
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CovidSurg-3
Identifier Type: -
Identifier Source: org_study_id