This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CovidSurg-3: Outcomes of Surgery in COVID-19 Infection (CovidSurg-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05161299
Recruitment Status : Not yet recruiting
First Posted : December 17, 2021
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
University of Birmingham

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.

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.

Condition or disease Intervention/treatment
SARS-CoV-2 Infection Surgery Procedure: Surgery (across all specialities)

Detailed Description:

Data collected in 2020 found patients with perioperative SARS-CoV-2 infection to be at increased risk of postoperative mortality (up to 24% at 30-days), pulmonary complications (up to 51% at 30-days), and venous thromboembolism1-5. Perioperative SARS-CoV-2 infection has been associated with increased mortality, morbidity, longer length of stay, and increased health system burdens compared to SARS-CoV-2 negative patients6-8.

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: CovidSurg-3: Outcomes of Surgery in COVID-19 Infection
Estimated Study Start Date : December 13, 2021
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : March 29, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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
 Procedure: Surgery (across all specialities)
Surgery performed by a surgeon in an operating theatre during the patient inclusion period


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To determine 30-day mortality in patients with peri-operative SARS-CoV-2 infection [ Time Frame: Up to 30 days post-surgery ]
    Collection of outcome data (up to 30 days post-surgery) for patients with peri-operative SARS-CoV-2


Secondary Outcome Measures :
  1. Rates of post-operative pulmonary complication and venous thromboembolism [ Time Frame: Up to 30 days post-surgery ]
    To determine 30-day postoperative pulmonary complication and venous thromboembolism rates in patients with peri-operative SARS-CoV-2 infection

  2. Evaluate implementation of SARS-CoV-2 mitigations and adaptations (vaccination, preoperative testing, COVID-free surgical pathways, patient selection) [ Time Frame: Recruitment period (mid Dec 2021 - end Feb 2022) ]
    Data collected will help inform future risk stratification and decision making

  3. Frequency of peri-operative SARS-CoV-2 infection [ Time Frame: 56 days ]
    To determine the frequency of peri-operative SARS-CoV-2 infection by collecting aggregated case-mix data at a hospital-level over blocks of 7 consecutive days

  4. Frequency of same-day elective surgery cancellations [ Time Frame: 56 days ]
    To determine the frequency of same-day elective surgery cancellations over blocks of 7 consecutive days


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients that underwent a surgical procedure during the patient inclusion period - 13 December 2021 to 28 February 2022 inclusive, 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 in-patient surgery
Criteria

Inclusion Criteria:

  • Patients that underwent surgery performed by a surgeon in an operating theatre, AND
  • 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:

  • They underwent minor procedures
  • 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 consecutive patients fulfilling inclusion criteria across all specialities should be captured.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05161299


Contacts
Layout table for location contacts
Contact: Dmitri Nepogodiev +44 (0)121 6272949 D.Nepogodiev@bham.ac.uk
Contact: Harvinder Mann hmann@hotmail.co.uk

Locations
Layout table for location information
United Kingdom
University of Birmingham
Birmingham, United Kingdom
Contact: Dmitri Nepogodiev       D.Nepogodiev@bham.ac.uk   
Principal Investigator: Aneel Bhangu         
Sponsors and Collaborators
University of Birmingham
Investigators
Layout table for investigator information
Principal Investigator: Aneel Bhangu University of Birmingham
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT05161299    
Other Study ID Numbers: CovidSurg-3
First Posted: December 17, 2021    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Birmingham:
SARS-CoV-2
Surgery
Rapid Antigen test
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
COVID-19
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
 Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases