Critical Analysis of the Results in the Management of Penetrating Abdominal Trauma in the Past Fifteen Years. (PAT-HMAR)

Critical Analysis of the Results in the Management of Penetrating Abdominal Trauma in the Past Fifteen Years. Do we Need to Change the Protocol?

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Penetrating Abdominal Trauma

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Ana María González Castillo, PhD; Phone Number: +34665126866; Email: amgonzalezcastillo@gmail.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with a penetrating trauma in the neck admitted in Hospital del Mar from 2008 to 2023.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital del Mar
• Investigators: Principal Investigator: Ana María González Castillo, PhD, Hospital del Mar

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Estimated): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Penetrating Trauma; Trauma surgery; Explorative laparoscopy; Trauma laparotomy; eFAST
• Additional Relevant MeSH Terms: Wounds and Injuries; Abdominal Injuries
• Other Study ID Numbers: Penetrating abdotrauma HMAR

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