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

• Conditions: Coronavirus; Surgery; COVID-19; Cancer
• Interventions: Procedure: Elective Cancer Surgery

• Registration Number: NCT04384926
• Lead Sponsor: University of Birmingham

Brief Summary

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

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 Timeline

• Study Start: 2020-03-30
• Status Verified: 2020-05
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-11
• Last Update Submitted: 2020-05-11
• Study First Posted: 2020-05-12
• Last Update Posted: 2020-05-12
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Elective Cancer Surgery	Adult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery completed during the COVID-19 pandemic
Cohort 2	Elective Cancer Surgery	Adult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery delayed or cancelled during the COVID-19 pandemic

Primary Outcome Measures

Name	Time	Method
30-day postoperative COVID-19 infection rate	30 days	Frequency of COVID-19 infection within 30 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital del Henares; 🇪🇸 Madrid, Spain