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

NCT05161299 | Unknown DMC

• 1 other identifier: CovidSurg-3
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection; Surgery

Keywords

SARS-CoV-2; Surgery; Rapid Antigen test

Outcome Measures

Primary Outcomes (1)

• To determine 30-day mortality in patients with peri-operative SARS-CoV-2 infection

  Collection of outcome data (up to 30 days post-surgery) for patients with peri-operative SARS-CoV-2

  Up to 30 days post-surgery

Secondary Outcomes (4)

• Rates of post-operative pulmonary complication and venous thromboembolism

  Up to 30 days post-surgery

• Evaluate implementation of SARS-CoV-2 mitigations and adaptations (vaccination, preoperative testing, COVID-free surgical pathways, patient selection)

  Recruitment period (mid Dec 2021 - end Feb 2022)

• Frequency of peri-operative SARS-CoV-2 infection

  56 days

• Frequency of same-day elective surgery cancellations

  56 days

Study Arms (1)

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)

Interventions

Surgery (across all specialities) PROCEDURE

Surgery performed by a surgeon in an operating theatre during the patient inclusion period

Control (normal practice)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

University of Birmingham

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Aneel Bhangu

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitri Nepogodiev

CONTACT

+44 (0)121 6272949; D.Nepogodiev@bham.ac.uk

Harvinder Mann

CONTACT

hmann@hotmail.co.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: December 17, 2021
• Study Start: December 13, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 29, 2022
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)