Critical Analysis of the Results in the Management of Penetrating Abdominal Trauma in the Past Fifteen Years.

Not yet recruiting

• Conditions: Penetrating Abdominal Trauma

• Registration Number: NCT06228261
• Lead Sponsor: Hospital del Mar

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-18
• Last Update Submitted: 2024-01-18
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Study Start: 2024-03-15
• Primary Completion: 2024-12-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	2008-2023	The second main outcome measure was the total of deaths in patients with a penetrating abdominal trauma assessed by preventable or non-preventable deaths.
Complications	2008-2023	The main outcome measure was the total of complications in patients with a penetrating abdominal trauma assessed by the Clavien-Dindo Classification.

Secondary Outcome Measures

Name	Time	Method
Explorations	2008-2023	To describe the explorations that has been ordered: eFAST, CT Scan, explorative laparoscopy or laparotomy.
Demographyc description	2008-2023	Description of the age and gender (Male / Female)
Physiologic description	2008-2023	Description of the vitals at arrival (bates per minute, blood pressure)
Wound and abdominal exploration	2008-2023	Description of the wound: bleeding, longitude, number of wounds and the abdominal explorations: peritonism or no peritonism.