Clinical trial NCT04449783: Preoperative Shielding and N/T RT-PCR Swabbing for Elective Cancer Surgery
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Cancer
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2020-06-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients undergoing elective cancer surgery with an inpatient stay

Brief summary: trial to assess the effectiveness of pre-operative screening for COVID-19 in patients undergoing elective cancer surgery.

Detailed description: 1. 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
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.

Eligibility criteria: 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

Primary outcomes:
measure: diagnosis of COVID before surgery
timeFrame: prior to surgery
Secondary outcomes:
measure: diagnosis of COVID after surgery
timeFrame: 14 days post op
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
state: Merseyside
Study officials:
affiliation: Liverpool University Hospitals NHS Foundation Trust
name: Robert Jones, MBChB
role: PRINCIPAL_INVESTIGATOR
References: