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
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- diagnosis of COVID before surgery
研究概览
简要总结
trial to assess the effectiveness of pre-operative screening for COVID-19 in patients undergoing elective cancer surgery.
详细描述
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
diagnosis of COVID before surgery
时间窗: prior to surgery
Diagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis)
次要结局
- diagnosis of COVID after surgery(14 days post op)
