Postoperative Mortality in Colombia: Perspectives of the Fourth Indicator in The Lancet Commission on Global Surgery (Colombian Surgical Outcomes Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,353
- 试验地点
- 2
- 主要终点
- In-hospital postoperative mortality
研究概览
简要总结
An observational, analytical, multicentre prospective cohort study will be conducted throughout Colombia. A sample size of 1353 patients is needed to achieve significance in our primary objective; however, convenience sampling is considered, as we aim to include all the institutions and patients possible. The data collection will be carried out prospectively for one week, and all patients will have a follow-up of a maximum of 30 days in-hospital. The primary outcome will be to determine the in-hospital mortality. We aim to contribute with accurate information on in-hospital postoperative mortality in Colombia. Thus, by following precisely the instructions created by The Lancet Commission on Global Surgery. The data obtained will help formulate public policies in the surgical field adjusted to the Colombian population, improving the quality of the surgical divisions in the different Colombian institutions, positively affecting the attention and development of the Colombian healthcare system.
详细描述
The general objective of this research is to describe the in-hospital postoperative mortality of patients who have had surgical procedures in Colombian institutions.
We also aim to characterize the sociodemographic and clinical variables of the patients that underwent a surgical procedure in Colombia, determine the secondary postoperative clinical outcomes associated with surgical procedures in Colombia and illustrate the installed surgical capacity and infrastructure of the participating health centres.
The study will be carried out throughout Colombia. The largest number possible of institutions in which surgeries are performed will be included. We expect to have at least 2 or 3 institutions per region. We currently have 65 confirmed participating institutions and have conducted a preliminary interaction with 257 institutions throughout the territory. The list of participating centres and researchers will be continuously updated, and the final version of the list will be attached to the final report.
A sample size estimate of 1353 patients was made to establish the lower limit needed to achieve significance in our primary objective. The estimate was made with the postoperative mortality rate in Colombia obtained in the study by Hanna et al. of 0.74% (13), an alpha value of 0.05, an accuracy of 0.5%, and a design effect of 1.2. Also, due to the nature of the study, it is not possible to randomize. Nevertheless, convenience sampling is considered, as we aim to include all the patients possible.
A descriptive analysis of the data will be performed. The continuous variables will be assessed whit normality tests (Shapiro Wilk or Kolmogorov Smirnov). If the variables have a normal distribution, they will be expressed as mean (measure of central tendency) and as standard deviation (measure of dispersion). Contrariwise, if the variables have a non-normal distribution, they will be expressed as median (measure of central tendency) and as interquartile range (measure of dispersion).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Patients over 18 years of age.
- •Ones who underwent to a surgical intervention in the collection period, by the participating institutions.
- •Both public and private institutions will be included.
- •Patients with and without COVID-19 infection will be included.
排除标准
- •Patients who do not have the necessary clinical records to complete the information during data collection.
- •Patients who do not approve inclusion in the study through informed consent.
- •The following shall be excluded:
- •Procedures that were performed outside of operating rooms.
- •Radiological procedures.
- •Endoscopic procedures.
结局指标
主要结局
In-hospital postoperative mortality
时间窗: 30 days
In-hospital postoperative mortality of patients who have had surgical procedures in Colombian institutions.
次要结局
- Postoperative complications(30 days)