National Retrospective Study of Duodenal Trauma (TRAUMADUOD)

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.

Study Overview

• Status: Recruiting
• Conditions: Duodenal Diverticulization; Pyloric Exclusion; Gastrojejunostomy; Retrograde Duodenostomy; Distal Feeding Tube; Resection and Whipple Procedures; Primary Repairs
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Damien MASSALOU; Phone Number: +33 0492033313; Email: massalou.d@chu-nice.Fr
• Study Contact Backup: Name: Sébastien FREY; Email: frey.s@chu-nice.fr

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06000
      • Recruiting
      • CHU de Nice
      • Principal Investigator: Damien MASSALOU
      • Contact: Sébastien FREY; Email: frey.s@chu-nice.fr
      • Contact: Damien MASSALOU; Phone Number: +33 0492033312; Email: massalou.d@chu-nice.fr
      • Sub-Investigator: Sébastien FREY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with duodenal trauma

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall mortality	Study mortality is overall mortality, not specific to abdominal trauma. It corresponds to grade 5 of the Clavien-Dindo classification.	1 month after trauma
Specific mortality	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.	1 month after trauma

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe morbidity	Morbidity will be recorded according to the Clavien-Dindo classification. We will study overall morbidity and severe morbidity (stages 3 and 4). As a reminder, stage 1 corresponds to a simple deviation from the operative course, stage 2 to medical treatment, stage 3 to interventional management (with or without general anaesthesia), and stage 4 to organ or multi-visceral failure.	3 months after trauma
Kind of treatment: medical, endoscopic or surgical	We will record the type of initial treatment performed, whether non-operative, endoscopic, laparoscopic or by laparotomy. We will collect the results of this initial treatment, including the possibility of complementary treatments, whatever the approach used and any failures. Non-operative management is defined as an exclusive medical attitude, including diagnostic imaging, but without interventional procedures. Interventional radiology management is defined as a percutaneous procedure performed under the control of diagnostic imaging, e.g. ultrasound- or scan-guided puncture of a collection. Endoscopic management includes diagnostic or therapeutic endoscopy, for example: endoscopic realignment of the Wirsung duct, puncture of a pancreatic pseudocyst, duodenal stenting, etc. Surgical management is defined as any surgical procedure requiring an opening of the abdomen. The approach is indicated as laparotomy or laparoscopy.	The first 3 months after trauma
type of injury of the duodenum	The surgeon is free to describe the lesions, in order to gather as much information as possible on the location of the lesion, its size, etc. We will also ask investigators to describe the lesions encountered, using the classification established by the AAST (American Association for the Surgery of Trauma).	no later than the 7th day after the trauma

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2023
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 23Urgences02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No