Clinical trial NCT06228261: Critical Analysis of the Results in the Management of Penetrating Abdominal Trauma in the Past Fifteen Years.
Official title: Critical Analysis of the Results in the Management of Penetrating Abdominal Trauma in the Past Fifteen Years. Do we Need to Change the Protocol?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Penetrating Abdominal Trauma
Keywords: Penetrating Trauma
Trauma surgery
Explorative laparoscopy
Trauma laparotomy
eFAST
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a penetrating trauma in the neck admitted in Hospital del Mar from 2008 to 2023.

Brief summary: Penetrating abdominal trauma (PAT) incidence varies between 3,1-12,8% and it comprises a wide range of injuries with varying patterns on diagnostic imaging. Last guidelines published in 2014 recommend the use of FAST and CXR as the Gold Standard method for evaluating. Computed Tomography (CT) is widely used in stable patients with PAT and it requires intravenous contrast and patient irradiation, leading to additional costs to healthcare services. This study aims to assess the management of PAT in our institution and with its results review the actual protocol.

Detailed description: Penetrating abdominal trauma (PAT) incidence varies between 3,1-12,8% and it comprises a wide range of injuries with varying patterns on diagnostic imaging. Last guidelines published in 2014 recommend the use of FAST and CXR as the Gold Standard method for evaluating. Computed Tomography (CT) is widely used in stable patients with PAT and it requires intravenous contrast and patient irradiation, leading to additional costs to healthcare services. This study aims to assess the management of PAT in our institution and with its results review the actual protocol.

A retrospective unicentric study will be conducted on a prospective database of stab wounds at the Department of General Surgery of Hospital del Mar over a 15-year period. The normality of the distribution of quantitative variables will be assessed using the Kolmogorov-Smirnov test. Comparison between qualitative variable groups will be performed using the Chi-square test or Fisher's exact test when appropriate, and non-parametric tests like the Mann-Whitney U test will be used to evaluate the significance of differences in means of quantitative variables. The odds ratios (OR) of predictor variables with outcome variables will be determined.

Eligibility criteria: Inclusion Criteria:

* All penetrating trauma patients admitted in the emergency department.

Exclusion Criteria:

* All patients with any other diagnostic different from penetrating trauma
* Blunt trauma patients admitted in the emergency department

Primary outcomes:
measure: Complications
timeFrame: 2008-2023
measure: Mortality
timeFrame: 2008-2023
Secondary outcomes:
measure: Explorations
timeFrame: 2008-2023
measure: Demographyc description
timeFrame: 2008-2023
measure: Physiologic description
timeFrame: 2008-2023
measure: Wound and abdominal exploration
timeFrame: 2008-2023
Other outcomes:
Locations:
Study officials:
affiliation: Hospital del Mar
name: Ana María González Castillo, PhD
role: PRINCIPAL_INVESTIGATOR
References: