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临床试验/NCT04444687
NCT04444687撤回不适用

Is SARS-CoV-2 Contaminating Surgical Aerosols From Laparoscopy and Open Abdominal Surgery?

University Hospital, Basel, Switzerland0 个研究点开始时间: 2020年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
SARS-COV-2 RNA detection

研究概览

简要总结

This study aims at answering the question if aerosols from laparoscopic or open abdominal surgery contain SARS-CoV-2 virus and need to be considered contagious.

详细描述

The CoVID-19 pandemic has led to wide spread shut down of surgical services and restrictions to emergency procedures in most European countries and the United States. Next to concerns about resource limitations this has been justified by the risk of viral transmission during surgery. As to date the virus has been isolated from several body fluids with highest viral loads in the respiratory tract but also in feces. Aerosol producing interventions such as intubation have been proven to be a common source of health care worker infections in Italy and recently in the United Kingdom and the United States. The risk of surgical smoke and steam in open and laparoscopic surgery has been considered to bear similar risk but no data concerning these aerosols has been published so far and to the knowledge of the investigators no trials are under way (www.clinicaltrials.gov 5.4.2020). Only limited data has been available for other viral infections such as Hepatitis B and Human Papilloma Virus showing that surgical aerosols have the potential to carry such infectious particles. This rational has led to conflicting recommendations by surgical societies such as the Royal College of Surgeons or the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) to avoid laparoscopic procedures or use special filtration systems to evacuate the smoke and aerosols from the body cavity.

Since Switzerland and the city of Basel in particular currently have a high prevalence for CoVID 19 it is likely that surgeons will encounter patients with proven or suspected infection in the near future that require open or laparoscopic emergency surgical procedures. This offers the opportunity to collect a reasonable number of samples and smears from the abdominal cavity and surgical aerosols from these patients in limited time to answer the urgent question whether surgical smoke and aerosols of the abdominal cavity from CoVID-19 patients are contagious or not.

Investigators consider the trial to be a risk category A according to art 7 (HRO). There is no risk for patients included in this trial since the treatment of the patients will not differ from standard care. There will be no extra tests performed and only routine data will be collected. Specimen from laparoscopic smoke filters which are a protection device for medical staff will be tested on SARS-CoV-2 contamination.

Primary Objective:

The primary objective of the study is to investigate the contamination of surgical smoke and aerosols with SARS-COV-2 virus particles using the viral genome as a marker during laparoscopic and open abdominal emergency procedures for patients with suspected or proven infection.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Age ≥ 18 years
  • Proven or suspected (not ruled out) SARS-CoV-2 infection (at the time of surgery)
  • Undergoing urgent or emergency laparoscopic or open abdominal surgery
  • Able to provide informed general consent on further use of clinical data

排除标准

  • Age < 18 years
  • Unable to provide informed general consent & no possibility of informed general consent by proxy
  • Recent (<24h) negative test for SARS-CoV-2

结局指标

主要结局

SARS-COV-2 RNA detection

时间窗: Up to 12 months

The primary outcome will be SARS-COV-2 RNA detection in filter systems for surgical aerosols in laparoscopic surgery (YES/NO). If viral RNA can be detected, the aerosols should be considered contagious, and therefore the debate on protective measures for the surgical staff in case of emergency surgery and possibly delaying any urgent surgery to protect surgical teams would be reasonable. If viral RNA cannot be detected, the aerosols do not need to be considered contagious for SARS-CoV-2, and CoVID-19 patients could safely be considered for laparoscopic and open abdominal surgery if indicated.

次要结局

  • Viral contamination of peritoneal cavity and fluid(Up to 12 months)
  • Viral infection of members of the surgical team(Up to 12 months)
  • Viral contamination of peritoneal cavity and fluid in open cases(Up to 12 months)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

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