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
研究概览
详细说明
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
- 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.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Merseyside
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Liverpool、Merseyside、英国、L9 7AL
- 招聘中
- Liverpool University Hospitals NHS Foundation Trust
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接触:
- Robert Jones, MBChB
- 电话号码:0151 525 5980
- 邮箱:robert.jones@liverpool.ac.uk
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首席研究员:
- Robert Jones, MBChB
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副研究员:
- Peter Gaskell, MBChB
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副研究员:
- Terry Jones, MBBS
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
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
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reported symptoms plus nose and throat swabbing 48 hrs prior to surgery
telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
diagnosis of COVID before surgery
大体时间:prior to surgery
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Diagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis)
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prior to surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
diagnosis of COVID after surgery
大体时间:14 days post op
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Diagnosis by day 14 (+/-2) post-surgery (based on Clinical symptoms from inpatient notes or telephone consultation +/- positive swab diagnosis)
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14 days post op
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合作者和调查者
调查人员
- 首席研究员:Robert Jones, MBChB、Liverpool University Hospitals NHS Foundation Trust
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
pre-operative screening的临床试验
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University of BarcelonaLaerdal Medical完全的
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Derya Öztürk ÖzenHacettepe University; Saglik Bilimleri Universitesi完全的