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Preoperative Shielding and N/T RT-PCR Swabbing for Elective Cancer Surgery

A Cohort Study to Assess the Effectiveness of Preoperative Shielding and N/T RT-PCR Swabbing for Elective Cancer Surgery Patients in the COVID-19 Pandemic

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04449783
Acronym
CHICANE
Enrollment
150
Registered
2020-06-29
Start date
2020-06-25
Completion date
2020-09-25
Last updated
2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Covid19

Brief summary

trial to assess the effectiveness of pre-operative screening for COVID-19 in patients undergoing elective cancer surgery.

Detailed description

1. Background: The optimal method of screening patients for COVID infection before elective cancer surgery is unclear. Provisional data from the international COVIDsurg audit as well as a similar study from China has shown mortality rates of in excess of 20% for COVID +ve patients undergoing surgery and so ensuring patients do not have infection before surgery is critical (1). Current practice for the preoperative screening of elective surgical patients involves a period of self-isolation, assessment of self-reported symptoms and nose and throat swab testing. Many patients are asymptomatic with COVID and the false negative rate of RT-PCR nose and throat swabs may be as high as 30% (2,3). Furthermore, we do not know how effective our strategy is at preventing hospital acquired COVID in the days after surgery. Patients are currently going to designated clean (silver) wards postoperatively to reduce this risk with other patient who have tested negatively to the above screening process too 2. Rationale: The aim of this study is to assess the rate of perioperative COVID in elective surgical patients, and to assess whether RT-PCR swabbing adds any additional value i.e. does it detect clinically important asymptomatic patients. If asymptomatic patients are diagnosed preoperatively this will reduce perioperative morbidity and mortality as well as confirming this as an appropriate preoperative screening process. Alternatively, should nose and throat swabbing not improve the diagnosis of COVID-19 in asymptomatic patients this trial may stop unnecessary visit to the hospital where they may be more likely to contract COVID-19 and reduce the use of a limited resource.

Interventions

OTHERpre-operative screening

reported symptoms plus nose and throat swabbing 48 hrs prior to surgery

OTHERtelephone consult

telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms

Sponsors

Liverpool University Hospitals NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* participants capable of giving informed consent, * gender: Male and Female * Age: 18 years and above * Preoperative cancer patients (elective) * Willing to be contacted by phone after hospital discharge * Patients listed for inpatient admission postoperatively (cancer patients)

Exclusion criteria

* Cancer patients who require non-cancer surgery * emergency cancer operations * Patients under the age of 18 * Patients who do not have capacity to consent * Cancer patients not requiring an inpatient stay postoperatively * Patients who it was not anticipated would require an inpatient stay preoperatively but required admission after surgery

Design outcomes

Primary

MeasureTime frameDescription
diagnosis of COVID before surgeryprior to surgeryDiagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis)

Secondary

MeasureTime frameDescription
diagnosis of COVID after surgery14 days post opDiagnosis by day 14 (+/-2) post-surgery (based on Clinical symptoms from inpatient notes or telephone consultation +/- positive swab diagnosis)

Countries

United Kingdom

Contacts

Primary ContactRobert Jones, MBChB
robert.jones@liverpool.ac.uk0151 525 5980
Backup ContactPeter Gaskell, MBChB
p.gaskell@doctors.org.uk0151 525 5980

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026