Global Outcomes After Laparotomy for Trauma: The GOAL-Trauma Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 552
- 主要终点
- Mortality
研究概览
简要总结
The goal of this observational study is to assessing the global variation in patient characteristics, management, and outcomes in those undergoing trauma laparotomy.
The main questions it aims to answer are:
- What are the post-operative mortality rates for patients undergoing a trauma laparotomy globally
- What are the epidemiological characteristics (demographics, injury characteristics, baseline clinical characteristics, and surgical case mix) for patients undergoing a trauma laparotomy
- What are the pre-operative, peri-operative, and post-operative processes of care for patients undergoing a trauma laparotomy
This is a purely observational study on patients undergoing trauma laparotomy, with no direct change to clinical care.
详细描述
We will conduct a prospective multi-centre observational cohort study of patients undergoing a trauma laparotomy. We will recruit centres through pre-existing research networks, utilising a snowballing technique to expand registration of centres. We will enrol eligible patients undergoing emergency trauma laparotomy over a consecutive 30 day period at individual centres during the study dates, with patients followed until discharge, death, or 30 days post-operatively, whichever comes first. All data will be submitted to a central study team by 30 days after the end of their respective data study period.
Any hospital worldwide that performs emergency trauma surgery will be eligible to participate, including both trauma centres and trauma units; a minimum of 1 case must be submitted by the centre during the 30 day study period to be eligible. Each centre's team will be comprised of a local study lead, with maximum 3 members of the local study team for each data collection period. Independent data validators will be also required for select centres.
We will include patients of all ages who present to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre (day 0 being time of presentation). A patient will be included for final analysis if >70% of the data points required have been recorded.
Exclusion criteria are:
- Patients undergoing a laparotomy ≥ 5 days (i.e. 120 hours) since presentation to the treating centre
- Any relook laparotomy, including transfers from another centre for further and / or definitive surgery
- Any laparoscopic (including laparoscopic converted to open), robotic, or image-guided procedures
- Patients who have been recently discharged from any hospital (including for non-trauma related admissions) and have represented within 30 days of discharge
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patients of any ages who presents to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre
排除标准
- •Patients undergoing a laparotomy ≥ 5 days (i.e. 120 hours) since presentation to the treating centre
- •Any relook laparotomy, including transfers from another centre for further and / or definitive surgery
- •Any laparoscopic (including laparoscopic converted to open), robotic, or image-guided procedures
- •Patients who have been recently discharged from any hospital (including for non-trauma related admissions) and have represented within 30 days of discharge
结局指标
主要结局
Mortality
时间窗: 30 days post-operatively
All cause 30-day post-operative mortality rate
次要结局
- Discharge Destination(30 days post-operatively)
- Length of Hospital Stay(30 days post-operatively)
- Morbidity Rates(30 days post-operatively)
研究者
Michael Bath
Research Student
University of Cambridge