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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Merseyside
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Liverpool, Merseyside, Regno Unito, L9 7AL
- Reclutamento
- Liverpool University Hospitals NHS Foundation Trust
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Contatto:
- Robert Jones, MBChB
- Numero di telefono: 0151 525 5980
- Email: robert.jones@liverpool.ac.uk
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Investigatore principale:
- Robert Jones, MBChB
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Sub-investigatore:
- Peter Gaskell, MBChB
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Sub-investigatore:
- Terry Jones, MBBS
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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diagnosis of COVID before surgery
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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diagnosis of COVID after surgery
Lasso di tempo: 14 days post op
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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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Robert Jones, MBChB, Liverpool University Hospitals NHS Foundation Trust
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Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SP0355
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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