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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.

研究概览

详细说明

  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.

研究类型

观察性的

注册 (预期的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Merseyside
      • Liverpool、Merseyside、英国、L9 7AL
        • 招聘中
        • Liverpool University Hospitals NHS Foundation Trust
        • 接触:
        • 首席研究员:
          • Robert Jones, MBChB
        • 副研究员:
          • Peter Gaskell, MBChB
        • 副研究员:
          • Terry Jones, MBBS

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All adult patients undergoing elective cancer surgery with an inpatient stay

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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

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

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Robert Jones, MBChB、Liverpool University Hospitals NHS Foundation Trust

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年6月25日

初级完成 (预期的)

2020年8月25日

研究完成 (预期的)

2020年9月25日

研究注册日期

首次提交

2020年6月23日

首先提交符合 QC 标准的

2020年6月23日

首次发布 (实际的)

2020年6月29日

研究记录更新

最后更新发布 (实际的)

2020年7月20日

上次提交的符合 QC 标准的更新

2020年7月17日

最后验证

2020年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

will not be shared

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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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