Postoperative Complications and Mortality of Patients Submited to Emergency Digestive Surgery During the COVID-19 Pandemic (COVIDCIR Study): a Multicenter Cohorts' Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,307
- 试验地点
- 1
- 主要终点
- 30-day mortality
研究概览
简要总结
A multi-centre, observational cohort study will be carried out in consecutive patients operated on for urgent digestive pathology. Two cohorts will be defined: the 'pandemic' cohort, which will include all patients [COVID-19-positive or negative] operated on for emergency digestive pathology during the months of March to June 2020; and the control cohort, which will include all patients operated on for emergency digestive pathology during the months of March to June 2019.
Information will be gathered on demographic characteristics, clinical and analytical parameters, scores on the usual risk scales for quality management in a General Surgery service (POSSUM, P-POSSUM and LUCENTUM scores), prognostic factors applicable to all patients, specific factors for patients infected with SARS-CoV-2, complications and postoperative mortality (at 30 and 90 postoperative days). In the pandemic cohort it will be detailed whether or not the patient was infected with SARS-CoV-2.
The main objective will be to determine the incidence of postoperative complications and mortality. This variable will be analysed in the "full analysis set" population. Secondary objective will be to develop a specific postoperative risk propensity model for SARS-CoV-2 infected patients.
详细描述
COVIDCIR is an observational, multicenter, cohorts' study of patients undergoing emergency/urgent gastrointestinal surgery during the period of maximum impact of the COVID-19 pandemic in Spain (from March 1st to June 30th, 2020).
The study conforms to the stipulations of the Declaration of Helsinki. The protocol was approved by the local Institutional Review Board (Ethics and Clinical Investigation Committee) and a waiver for written informed consent was given. The level of protection of confidentiality, in terms of protection of personal data as required by Spanish Law (LOPD 3/2018), was also ensured.
A total of 30 surgical teams from different Spanish hospitals have been proposed as participants in this study, which has been coordinated by the Department of General and Digestive Surgery of Bellvitge University Hospital (L'Hospitalet del Llobregat, Barcelona, Spain). All hospitals participating are from Spain, with different surgical capabilities.
Patients operated on for emergency/urgent gastrointestinal surgery constitute the target population.
Inclusion criteria: ≥18 years, both genders, and operated on for urgent/emergency gastrointestinal pathology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patients ≥18 years, both genders, and operated on for urgent/emergency gastrointestinal pathology.
排除标准
- •Patients who have undergone a scheduled surgical intervention or patients operated on by a service other than General and Digestive Surgery.
- •Patients < 18 years old
结局指标
主要结局
30-day mortality
时间窗: 30 days post-surgery
Mortality for any cause at 30 days after urgent gastrointestinal surgery.
次要结局
- 90-day mortality(90 days post-surgery)
- Postoperative complications(30 days post-surgery)
- Severe complications(30 days post-surgery)
- Lenght of stay(90 days post-surgery)
研究者
Javier Osorio
Javier Osorio
Hospital Universitari de Bellvitge