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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05161299
Recruitment Status : Unknown
Verified December 2021 by University of Birmingham.
Recruitment status was:  Not yet recruiting
First Posted : December 17, 2021
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
University of Birmingham

Tracking Information
First Submitted Date December 16, 2021
First Posted Date December 17, 2021
Last Update Posted Date December 17, 2021
Estimated Study Start Date December 13, 2021
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 16, 2021)		 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 16, 2021)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CovidSurg-3: Outcomes of Surgery in COVID-19 Infection
Official Title CovidSurg-3: Outcomes of Surgery in COVID-19 Infection
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • SARS-CoV-2 Infection
  • Surgery
Intervention Procedure: Surgery (across all specialities)
Surgery performed by a surgeon in an operating theatre during the patient inclusion period
Study Groups/Cohorts 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
Intervention: Procedure: Surgery (across all specialities)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 16, 2021)		 2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 29, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT05161299
Other Study ID Numbers CovidSurg-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party University of Birmingham
Original Responsible Party Same as current
Current Study Sponsor University of Birmingham
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Aneel Bhangu University of Birmingham
PRS Account University of Birmingham
Verification Date December 2021