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trial to assess the effectiveness of pre-operative screening for COVID-19 in patients undergoing elective cancer surgery.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pre-operative screening | Other | reported symptoms plus nose and throat swabbing 48 hrs prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| diagnosis of COVID before surgery | Diagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis) | prior to surgery |
| Measure | Description | Time Frame |
|---|---|---|
| diagnosis of COVID after surgery | Diagnosis by day 14 (+/-2) post-surgery (based on Clinical symptoms from inpatient notes or telephone consultation +/- positive swab diagnosis) | 14 days post op |
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Inclusion Criteria:
Exclusion Criteria:
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All adult patients undergoing elective cancer surgery with an inpatient stay
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Jones, MBChB | Contact | 0151 525 5980 | robert.jones@liverpool.ac.uk | |
| Peter Gaskell, MBChB | Contact | 0151 525 5980 | p.gaskell@doctors.org.uk |
| Name | Affiliation | Role |
|---|---|---|
| Robert Jones, MBChB | Liverpool University Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool University Hospitals NHS Foundation Trust | Recruiting | Liverpool | Merseyside | L9 7AL | United Kingdom |
will not be shared
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| telephone consult | Other | telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |