Impact of the COVID-19 Pandemic on the Surgical Activity of Bellvitge University Hospital
2021年3月2日 更新者：Marta Caballero Milan、Hospital Universitari de Bellvitge
Impact of the SARS-CoV-2 (COVID-19) Pandemic on the Morbidity and Mortality of Patients Undergoing Surgery at Bellvitge University Hospital
COVID-19 has been a challenge for hospitals; there was an obvious need to reconvert many spaces in specific areas to attend this pathology, without forgetting the attention to other pathologies and surgery.
The objective of the investigators is to evaluate the impact of this pandemic in the patients who underwent surgery in Bellvitge University Hospital, analyzing 2 periods of time: the months before the COVID-19 peak and the COVID-19 peak months.
研究概览
地位
完全的
详细说明
A total of 2.530 procedures have been evaluated in this retrospective observational study.
Two groups have been generated (pre-pandemic period and pandemic period), classified into scheduled and emergency surgery.
The investigators determined age, type of surgery and specialty, hospital stay, destination at discharge including mortality and severity according to Diagnostic Related to Group (DRG) scale.
The investigators have also determined the number of confirmed COVID-19 infections in patients who underwent surgery during these 2 periods and evaluated if the infection was due to a nosocomial infection (confirmation of the COVID-19 during the hospitalization period).
Comparisons were made between subgroups: scheduled surgery performed during the 2 periods and emergency surgery performed during the 2 periods.
研究类型
观察性的
注册 (实际的)
2530
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
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Barcelona
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Hospitalet de Llobregat、Barcelona、西班牙、08907
- Marta Caballero
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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
The requirement to include patients was that they required surgery, either urgent or scheduled, during the periods described (PreCOVID and COVID).
As there is no paediatric service in the hospital, the minimum age of the sample is 18 years old but there is no maximum age for inclusion.
描述
Inclusion Criteria:
- All surgical patients operated, both elective scheduled and emergent cases
Exclusion Criteria:
- Minor-intermediate surgery that involves discharge from the hospital on the same day of the surgery from the Pre-pandemic period.
- Procedures related to medical treatment or complications of COVID-19 patients, such as chest tubes, extracorporeal oxygenation or tracheostomy.
- Those scheduled elective surgery patients in the Covid period that resulted RT-PCR positive, surgery was posponed, were not considered eligible for the analysis.
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 |
|---|---|
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Pre-pandemic COVID-19 group (PreCOVID)
All patients who underwent surgery from 13th January until 29th February 2020, which are considered free of COVID-19 patients, therefore pre-pandemic period.
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Administrative database was automatically collected.
That included demographic, clinical antecedents, surgical team and surgical procedure, primary and secondary diagnoses and principal and secondary surgical procedures.
A case-mix grouping system administrative automatic recorded based on the ICD-10-AM International Classification of Diseases.
According to the Diagnoses-related Groups (DRG's).
the Severity of Illness Index assigns to each patient an overall severity score (from 1 to 4) and mortality risk score (from 1 to 4)
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Pandemic COVID-19 group (COVID)
All patients who underwent surgery from 11th March 2020 until 15th May 2020, which were done during the first wave of the pandemic crisis.
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Administrative database was automatically collected.
That included demographic, clinical antecedents, surgical team and surgical procedure, primary and secondary diagnoses and principal and secondary surgical procedures.
A case-mix grouping system administrative automatic recorded based on the ICD-10-AM International Classification of Diseases.
According to the Diagnoses-related Groups (DRG's).
the Severity of Illness Index assigns to each patient an overall severity score (from 1 to 4) and mortality risk score (from 1 to 4)
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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 |
|---|---|---|
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Register the post-surgical complications
大体时间：PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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Register and Compare the Rate of Surgical Reintervention between both periods.
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PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Register the rate of surgical reintervention
大体时间：PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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Register and compare the Rate of reintervention between both periods.
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PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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Register the ICU admission
大体时间：PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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register and compare the ICU admission between both periods.
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PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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Register the Hospital stay
大体时间：PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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register and compare the ICU admission between both periods.
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PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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Register the Mortality
大体时间：PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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register and compare the Mortality between both periods.
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PreCOVID group from 13th January 2020 to 29th February 2020 and COVID group from 11th March 2020 to 15th May 2020.
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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：Maria Jose MJ Colomina, PhD、Head of the department
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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2月13日
初级完成 (实际的)
2020年5月15日
研究完成 (实际的)
2020年12月9日
研究注册日期
首次提交
2021年3月1日
首先提交符合 QC 标准的
2021年3月2日
首次发布 (实际的)
2021年3月3日
研究记录更新
最后更新发布 (实际的)
2021年3月3日
上次提交的符合 QC 标准的更新
2021年3月2日
最后验证
2021年3月1日
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.