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

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

Study Overview

• Status: Unknown
• Conditions: Cancer; Covid19
• Intervention / Treatment: Other: pre-operative screening; Other: telephone consult

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L9 7AL
      • Recruiting
      • Liverpool University Hospitals NHS Foundation Trust
      • Contact: Robert Jones, MBChB; Phone Number: 0151 525 5980; Email: robert.jones@liverpool.ac.uk
      • Principal Investigator: Robert Jones, MBChB
      • Sub-Investigator: Peter Gaskell, MBChB
      • Sub-Investigator: Terry Jones, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients undergoing elective cancer surgery with an inpatient stay

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnosis of COVID before surgery	Diagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis)	prior to surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Liverpool University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Robert Jones, MBChB, Liverpool University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Anticipated): August 25, 2020
• Study Completion (Anticipated): September 25, 2020

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SP0355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No