Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis (CovidSurg-Can)

University of Birmingham

Status: Unknown

Conditions: COVID-19; Surgery; Cancer; Coronavirus

Treatments: Procedure: Elective Cancer Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04384926

CSC-20200324

Details and patient eligibility

About

CovidSurg-Cancer is an international, multicentre, observational cohort study designed to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic.

Centres can elect to include one or more cancer types in the study, in any combination, depending on local expertise and capacity. During the pilot study, investigators should enrol patients with confirmed diagnoses of:

• Colorectal cancer
• Oesophagogastric cancer

As a rapid response study to the COVID-19 pandemic, included cancer types will evolve throughout the course of the CovidSurg-Cancer study period, for example, to include breast, liver, pancreatic, gynaecological, urological cancers, or sarcomas.

Full description

The rapid emergence of the COVID-19 virus has led to a global impact on elective surgical care.

We have very little evidence to guide us. The magnitude and effects of these changes are uncertain. The safety of operating on patients electively with the risks of COVID-19 postoperative pneumonia is unknown.

High-quality data will allow policy planning at regional and hospital level for both this outbreak and future pandemics. CovidSurg-Cancer will run in parallel to CovidSurg (which is capturing outcomes of patients undergoing surgery for all indications with concurrent COVID-19).

The primary aim is to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic.

Secondary aims include; comparison of the 30-day postoperative mortality rate in cancer surgery patients that develop COVID-19 infection versus those who do not; an exploration of the scale of resource constraints related to the COVID-19 pandemic, and their impact on outcomes of elective cancer surgery; to explore variation in the selection of patients for continuing elective cancer surgery during the COVID-19 pandemic; to evaluate the impact of the COVID-19 pandemic on treatment pathways for cancers with a decision for surgical resection with curative intent.

This investigator-led, non-commercial, non-interventional study is extremely low to zero risk. This study does not collect any patient identifiable information and data will not be analysed at hospital-level.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Centre Inclusion Criteria:

• Any centre performing elective cancer surgery

Inclusion Criteria (patient):

• Adults (age ≥18 years) with a confirmed diagnosis of an included cancer type
• Decision made for surgical management with a curative intent

Exclusion Criteria:

• Surgery planned with non-curative intent
• Planned neoadjuvant therapy without a firm date for surgery, or awaiting restaging

Trial design

1,000 participants in 2 patient groups

Cohort 1

Description:

Adult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery completed during the COVID-19 pandemic

Treatment:

Procedure: Elective Cancer Surgery

Cohort 2

Description:

Adult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery delayed or cancelled during the COVID-19 pandemic

Treatment:

Procedure: Elective Cancer Surgery