Preoperative Shielding and N/T RT-PCR Swabbing for Elective Cancer Surgery

Cancer Clinical Trial

— CHICANE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04449783
• Other study ID #: SP0355
• Status: Recruiting
• Start date: June 25, 2020
• Est. completion date: September 25, 2020

Study information

• Verified date: June 2020
• Source: Liverpool University Hospitals NHS Foundation Trust
• Contact: Robert Jones, MBChB
• Phone: 0151 525 5980
• Email: robert.jones[@]liverpool.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 25, 2020
• Est. primary completion date: August 25, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Covid19

Intervention

Other:
• pre-operative screening
reported symptoms plus nose and throat swabbing 48 hrs prior to surgery
• telephone consult
telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms

Locations

Country	Name	City	State
United Kingdom	Liverpool University Hospitals NHS Foundation Trust	Liverpool	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis of COVID before surgery	Diagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis)	prior to surgery
Secondary	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