Preoperative Shielding and N/T RT-PCR Swabbing for Elective Cancer Surgery
NCT ID: NCT04449783
Last Updated: 2020-07-20
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
150 participants
OBSERVATIONAL
2020-06-25
2020-09-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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study patients
Patients undergoing elective cancer surgery, who will receive pre-operative screening including reporting symptoms and nose and throat swabbing 48 hours prior to surgery
pre-operative screening
reported symptoms plus nose and throat swabbing 48 hrs prior to surgery
telephone consult
telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms
Interventions
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pre-operative screening
reported symptoms plus nose and throat swabbing 48 hrs prior to surgery
telephone consult
telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Liverpool University Hospitals NHS Foundation Trust
OTHER_GOV
Responsible Party
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Principal Investigators
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Robert Jones, MBChB
Role: PRINCIPAL_INVESTIGATOR
Liverpool University Hospitals NHS Foundation Trust
Locations
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Liverpool University Hospitals NHS Foundation Trust
Liverpool, Merseyside, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SP0355
Identifier Type: -
Identifier Source: org_study_id
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