- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04449783
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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
Merseyside
-
Liverpool, Merseyside, Det Forenede Kongerige, L9 7AL
- Rekruttering
- Liverpool University Hospitals NHS Foundation Trust
-
Kontakt:
- Robert Jones, MBChB
- Telefonnummer: 0151 525 5980
- E-mail: robert.jones@liverpool.ac.uk
-
Ledende efterforsker:
- Robert Jones, MBChB
-
Underforsker:
- Peter Gaskell, MBChB
-
Underforsker:
- Terry Jones, MBBS
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
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
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
diagnosis of COVID before surgery
Tidsramme: prior to surgery
|
Diagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis)
|
prior to surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
diagnosis of COVID after surgery
Tidsramme: 14 days post op
|
Diagnosis by day 14 (+/-2) post-surgery (based on Clinical symptoms from inpatient notes or telephone consultation +/- positive swab diagnosis)
|
14 days post op
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Robert Jones, MBChB, Liverpool University Hospitals NHS Foundation Trust
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SP0355
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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