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临床试验/NCT06058975
NCT06058975已完成不适用

National Retrospective Study of Duodenal Trauma

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2023年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
1
主要终点
Specific mortality

研究概览

简要总结

Duodenal injuries remain rare among abdominal trauma, concerning less than 5 % of cases. However, due to its central location, it is most commonly associated with multiple organs lesions, with the main three organs being the liver, the colon and the pancreas. Additionally, the penetrating mechanism is four times more common than blunt trauma and the most common duodenal site of injury is the second portion (36 %), the least being the first duodenum (13 %). These particularities generate a high morbidity, ranging from 22 to 27.1 %, and a mortality still as high as 5.3 to 30 % today. When facing it, surgeons are usually challenged in their strategy. Indeed, when surgery is required, different options can be chosen depending on the grade of the lesion and the involvement of the papilla and/or other organs. Primary repairs, duodenal diverticulization, pyloric exclusion, gastrojejunostomy, retrograde duodenostomy, distal feeding tube, or even resection and Whipple procedures, have all been described. Since the classification of the American Association for the surgery of trauma (AAST), most studies stratified their management as such: drainage only or primary repair for grade 1 and 2, jejunostomy and/or pyloric exclusion for grade 3, Whipple for grade 4 or 5. However, reviews of the literature aren't clear if this decisional tree is in correlation with lower morbidities, and often different procedures have been reported for the same grade. The escalation of technical exclusions among severe grades became controversial. As an example, pyloric exclusion has been criticized in its preventive role of protecting the suture, being useless at least, or even worse at times. Thus, in the recent years, the management has been focused towards minimization. Indeed, in the retrospective review of the Pan-American trauma society primary repair alone was performed in 80 % of cases, all grades comprised. Although mortality was high, duodenal suture line leak was statistically lower among survivors over every grade.

To clear the situation, prospective studies are difficult if not impossible in such context. Thus, The investigators propose this national benchmark, to retrospectively review in France the management of duodenal trauma, depending on the grade, and its associated morbidity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with duodenal trauma,
  • older than 18 years old.

排除标准

  • pregnancy
  • previous duodenal surgery.
  • Associated surrounding organs trauma, was not an exclusion criterion, but duodenal trauma must have been one of the main injuries.

结局指标

主要结局

Specific mortality

时间窗: 1 month after trauma

Specific mortality is the mortality due to abdominal trauma, including abdominal compartment syndrome, coagulopathy, hemorrhage, multi-organ failure, etc. It excludes brain death, mortality due to trauma of other body regions. It corresponds to grade 5 of the Clavien-Dindo classification.

Overall mortality

时间窗: 1 month after trauma

Study mortality is overall mortality, not specific to abdominal trauma. It corresponds to grade 5 of the Clavien-Dindo classification.

次要结局

  • type of injury of the duodenum(no later than the 7th day after the trauma)
  • Severe morbidity(3 months after trauma)
  • Kind of treatment: medical, endoscopic or surgical(The first 3 months after trauma)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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