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临床试验/CTRI/2024/09/074317
CTRI/2024/09/074317尚未招募不适用

An observational study assessing the global variation in patient characteristics, management, and outcomes in those undergoing trauma laparotomy

University of Cambridge1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2024年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
3,000
试验地点
1
主要终点
global patient, injury, and surgical factors for patients undergoing trauma laparotomy

研究概览

简要总结

Trauma accounts for approximately 9% of all global deaths  and contributes the greatest loss of disability-adjusted life-years for adolescents and young adults worldwide . In the context of global abdominal trauma, both blunt and penetrating, the trauma laparotomy is the most commonly performed operation; it can be used both as a means to access identified injuries to organs within the abdomen and pelvis, such as life-threatening bleeding (from vessels or solid organs) or contamination (from hollow viscus injuries), or for exploratory diagnostic reasons, where cross-sectional imaging may not be easily feasible or available. Whilst mortality rates following a trauma laparotomy are substantial, ranging between 8-40% (3–8), in recent years the role of damage control resuscitation has transformed trauma care, with significant reduction in mortality and morbidity to trauma patients being observed .However, the standard of care and variation in practice occurring globally for patients undergoing a trauma laparotomy remain relatively unknown.Variation likely exists worldwide in the management and outcomes of patients following trauma laparotomy however at present its limited data exists. Hence, this study is to evaluate both patient and injury factors for those undergoing trauma laparotomy, their clinical management, and post-operative outcomes.Data will be collected through access to patient records only at each centre, performed by members of the local study team. The patient will not be contacted directly in any during their inpatient stay or after the study. The study is observational and no direct involvement in patient care will occur. Data will be collected either directly onto the REDCap cloud (see Data Management) or recorded temporarily onto a hard copy Data Collection Form, which will then be stored securely before the data then is uploaded to the REDCap cloud (with the forms subsequently being destroyed safely).The mean and standard deviation will be reported for all normally distributed variables and the median and interquartile range for non-normally distributed variables. Participating centres will be stratified based on their country into groups based on their Human Development Index (HDI) rank, with 30-day mortality then reported for each HDI group and compared using the Pearson chi squared test.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 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 timeof presentation).
  • A patient will be included for final analysis if >70% of the data points required have been recorded.

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

global patient, injury, and surgical factors for patients undergoing trauma laparotomy

时间窗: 4 weeks

次要结局

  • Determining the global pre-, peri-, & post-operative care process for patients undergoing trauma laparotomy(8 weeks)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Tej Prakash Sinha

AIIMS, New Delhi

研究点 (1)

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