Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis: an International, Multicentre, Observational Cohort Study (CovidSurg-Cancer)

Conditions
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COVID-19, Coronavirus, Cancer, Surgery

Intervention / Treatment
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* Procedure: Elective Cancer Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Adult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery completed during the COVID-19 pandemic | Procedure: Elective Cancer Surgery<br>* Planned, curative cancer surgery<br>|
| Cohort 2<br>Adult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery delayed or cancelled during the COVID-19 pandemic | Procedure: Elective Cancer Surgery<br>* Planned, curative cancer surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day postoperative COVID-19 infection rate | Frequency of COVID-19 infection within 30 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day postoperative mortality rate | Number of deaths at 30-days post surgery | 30-days | 
| Postoperative critical care utilisation rate in high-risk cancer surgery patients. | Critical care utilisation in high-risk cancer surgery patients | 30-days | 
| Proportion of patients with delay of greater than 4 weeks from decision for surgery to date of surgery | Number of patients with a delay of more than 4 weeks from the decision taken for surgery to the date of surgery | More than 4 weeks from decision date | 
| Proportion of non-operated patients with progression to incurable disease by 3-months after decision for surgery | Number of non-operated patients with progression to incurable disease by 3-months after decision for surgery | Up to 3-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elective, Cancer Surgery