Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis
NCT ID: NCT04384926
Last Updated: 2020-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2020-03-30
2020-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Cohort 1
Adult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery completed during the COVID-19 pandemic
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
Elective Cancer Surgery
Planned, curative cancer surgery
Interventions
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Elective Cancer Surgery
Planned, curative cancer surgery
Eligibility Criteria
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Inclusion Criteria
* Adults (age ≥18 years) with a confirmed diagnosis of an included cancer type
* Decision made for surgical management with a curative intent
Exclusion Criteria
* Planned neoadjuvant therapy without a firm date for surgery, or awaiting restaging
18 Years
ALL
No
Sponsors
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University of Birmingham
OTHER
Responsible Party
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Principal Investigators
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Aneel Bhangu
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham
Locations
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Hospital del Henares
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Ana Minaya-Bravo
Role: primary
References
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NIHR Global Health Research Unit on Global Surgery; STARSurg Collaborative. A prognostic model for use before elective surgery to estimate the risk of postoperative pulmonary complications (GSU-Pulmonary Score): a development and validation study in three international cohorts. Lancet Digit Health. 2024 Jul;6(7):e507-e519. doi: 10.1016/S2589-7500(24)00065-7.
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.
Other Identifiers
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CSC-20200324
Identifier Type: -
Identifier Source: org_study_id
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