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

NCT ID: NCT04449783

Last Updated: 2020-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-25

Study Completion Date

2020-09-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Covid19 Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

pre-operative screening

Intervention Type OTHER

reported symptoms plus nose and throat swabbing 48 hrs prior to surgery

telephone consult

Intervention Type OTHER

telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms

Interventions

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pre-operative screening

reported symptoms plus nose and throat swabbing 48 hrs prior to surgery

Intervention Type OTHER

telephone consult

telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Jones, MBChB

Role: PRINCIPAL_INVESTIGATOR

Liverpool University Hospitals NHS Foundation Trust

Locations

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Liverpool University Hospitals NHS Foundation Trust

Liverpool, Merseyside, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Robert Jones, MBChB

Role: CONTACT

0151 525 5980

Peter Gaskell, MBChB

Role: CONTACT

0151 525 5980

Facility Contacts

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Robert Jones, MBChB

Role: primary

0151 525 5980

Other Identifiers

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SP0355

Identifier Type: -

Identifier Source: org_study_id

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