Clinical trial NCT06058975: National Retrospective Study of Duodenal Trauma
Official title: National Retrospective Study of Duodenal Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duodenal Diverticulization
Pyloric Exclusion
Gastrojejunostomy
Retrograde Duodenostomy
Distal Feeding Tube
Resection and Whipple Procedures
Primary Repairs
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with duodenal trauma

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Overall mortality
timeFrame: 1 month after trauma
measure: Specific mortality
timeFrame: 1 month after trauma
Secondary outcomes:
measure: Severe morbidity
timeFrame: 3 months after trauma
measure: Kind of treatment: medical, endoscopic or surgical
timeFrame: The first 3 months after trauma
measure: type of injury of the duodenum
timeFrame: no later than the 7th day after the trauma
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes Maritimes
Study officials:
References: