Observational Cohort Study of Patient Outcomes Following Surgery in Latin American Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23,000
- 试验地点
- 1
- 主要终点
- Postoperative complications
研究概览
简要总结
Methods: International, seven-day observational cohort study of complications following elective or emergency surgery. Objectives: To provide detailed data describing post-operative complications and associated mortality. Number of participants: Our aim is to recruit as many patients from as many hospitals as possible in Latin American nations. Eligible countries for participation: Countries and dependencies in Latin America that are situated in the area stretching from the northern border of Mexico to the southern tip of South America, including the Caribbean. Inclusion criteria: all adult patients aged 18 years or older undergoing elective or emergency surgery during the seven-day study period with a planned overnight stay. Exclusion criteria: patients who are undergoing planned day-case surgery or radiological procedures. Statistical methodology and analysis: Single and multi-level logistic regression models will be constructed to identify factors independently associated with these outcomes and to adjust for differences in confounding factors. A single final analysis is planned at the end of the study. A pre-defined analysis will focus on outcomes of patients who have undergone caesarean section. Study duration: Each nation will select a 7-day period between 1st April and 31th October 2022.
详细描述
Introduction
More than 310 million patients undergo surgery worldwide each year with reported hospital mortality between 1 and 4%. Recent estimates suggest that 4.2 million deaths occur within 30 days of surgery, and half of these occur in low and middle-income countries (LMIC). Complications are more common and are a leading cause of long-term morbidity and mortality. The International Surgical Outcomes Study (ISOS) confirmed the association between complications and death after surgery at a global scale, but predominantly included high-income nations. More recently, the African Surgical Outcomes Study (ASOS) found that patients undergoing surgery in African nations were twice as likely to die than those in high-income countries (HIC), despite being younger with fewer co-morbid diseases. While there is a global drive to improve access to surgery in LMICs there is a need to implement this safely. Latin America describes a geographic area including 25 nations, and countries within the region have some of the highest income disparity worldwide. Rapid demographic and societal changes have led to an increasing burden of non-communicable disease. Provision of healthcare varies widely within Latin America, with a mix of private, social and government funded schemes. The investigators aim is to conduct a seven-day cohort study of adults undergoing in-patient surgery in Latin America to provide detailed data describing post-operative complications and associated mortality.
Study objectives
Primary objective To evaluate the incidence of 30-day in-hospital complications following elective or emergency in-patient surgery
Secondary objective
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
- 是
入选标准
- •All adult patients (aged 18 years or older) undergoing elective or emergency surgery with a planned overnight stay.
- •Surgery is defined as a procedure where a deliberate access to the body is gained via an incision or percutaneous puncture, and where instrumentation is used in addition to the puncture needle, or instrumentation via a natural orifice.
排除标准
- •Patients who are undergoing planned day-case surgery or radiological procedures.
结局指标
主要结局
Postoperative complications
时间窗: 30 days
In-hospital postoperative complications of any cause, censored at 30 days following surgery for patients who remain in hospital
次要结局
- Mortality(30 days)
- Hospital stay(30 days)
- Critical care(30 days)
研究者
Ludhmila Abrahão Hajjar MD, PhD
Associate Professor
University of Sao Paulo