Preoperative Shielding and N/T RT-PCR Swabbing for Elective Cancer Surgery (CHICANE)
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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Merseyside
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Liverpool, Merseyside, Verenigd Koninkrijk, L9 7AL
- Werving
- Liverpool University Hospitals NHS Foundation Trust
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Contact:
- Robert Jones, MBChB
- Telefoonnummer: 0151 525 5980
- E-mail: robert.jones@liverpool.ac.uk
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Hoofdonderzoeker:
- Robert Jones, MBChB
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Onderonderzoeker:
- Peter Gaskell, MBChB
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Onderonderzoeker:
- Terry Jones, MBBS
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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
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reported symptoms plus nose and throat swabbing 48 hrs prior to surgery
telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
diagnosis of COVID before surgery
Tijdsspanne: prior to surgery
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Diagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis)
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prior to surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
diagnosis of COVID after surgery
Tijdsspanne: 14 days post op
|
Diagnosis by day 14 (+/-2) post-surgery (based on Clinical symptoms from inpatient notes or telephone consultation +/- positive swab diagnosis)
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14 days post op
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Robert Jones, MBChB, Liverpool University Hospitals NHS Foundation Trust
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SP0355
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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