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

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

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19; Cancer; Surgery; Coronavirus
• Intervention / Treatment: Procedure: Elective Cancer Surgery

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Aneel Bhangu; Phone Number: +44 1216272949; Email: A.A.Bhangu@bham.ac.uk
• Study Contact Backup: Name: Dmitri Nepogodiev; Phone Number: +44 1216272949; Email: D.Nepogodiev@bham.ac.uk

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital del Henares
    • Contact: Ana Minaya-Bravo
    • Principal Investigator: Ana Minaya-Bravo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Patients planned for curative cancer surgery that have surgery completed during the COVID-19 pandemic
• Patients planned for curative cancer surgery that have surgery delayed or cancelled during the COVID-19 pandemic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Adult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery completed during the COVID-19 pandemic	Procedure: Elective Cancer Surgery; Planned, curative cancer surgery
Cohort 2; 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; Planned, curative cancer surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Birmingham
• Investigators: Principal Investigator: Aneel Bhangu, University of Birmingham

Publications and helpful links

General Publications

• COVIDSurg Collaborative. Effect of COVID-19 pandemic lockdowns on planned cancer surgery for 15 tumour types in 61 countries: an international, prospective, cohort study. Lancet Oncol. 2021 Nov;22(11):1507-1517. doi: 10.1016/S1470-2045(21)00493-9. Epub 2021 Oct 5.
• Glasbey JC, Nepogodiev D, Simoes JFF, Omar O, Li E, Venn ML, Pgdme, Abou Chaar MK, Capizzi V, Chaudhry D, Desai A, Edwards JG, Evans JP, Fiore M, Videria JF, Ford SJ, Ganly I, Griffiths EA, Gujjuri RR, Kolias AG, Kaafarani HMA, Minaya-Bravo A, McKay SC, Mohan HM, Roberts KJ, San Miguel-Mendez C, Pockney P, Shaw R, Smart NJ, Stewart GD, Sundar Mrcog S, Vidya R, Bhangu AA; COVIDSurg Collaborative. Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study. J Clin Oncol. 2021 Jan 1;39(1):66-78. doi: 10.1200/JCO.20.01933. Epub 2020 Oct 6.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Elective; Cancer Surgery
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CSC-20200324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual participant data will be made available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No