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

• Conditions: Covid19; Cancer
• Interventions: Other: pre-operative screening; Other: telephone consult

• Registration Number: NCT04449783
• Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust

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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-06-23
• Study Start: 2020-06-25
• Study First Posted: 2020-06-29
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20
• Primary Completion: 2020-08-25
• Study Completion: 2020-09-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study patients	pre-operative screening	Patients undergoing elective cancer surgery, who will receive pre-operative screening including reporting symptoms and nose and throat swabbing 48 hours prior to surgery
study patients	telephone consult	Patients undergoing elective cancer surgery, who will receive pre-operative screening including reporting symptoms and nose and throat swabbing 48 hours prior to surgery

Primary Outcome Measures

Name	Time	Method
diagnosis of COVID before surgery	prior to surgery	Diagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis)

Secondary Outcome Measures

Name	Time	Method
diagnosis of COVID after surgery	14 days post op	Diagnosis by day 14 (+/-2) post-surgery (based on Clinical symptoms from inpatient notes or telephone consultation +/- positive swab diagnosis)

Trial Locations

Locations (1)

Liverpool University Hospitals NHS Foundation Trust; 🇬🇧 Liverpool, Merseyside, United Kingdom