NCT06228261

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

January 18, 2024

Last Update Submit

January 18, 2024

Conditions

Keywords

Penetrating TraumaTrauma surgeryExplorative laparoscopyTrauma laparotomyeFAST

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Explorations

    2008-2023

  • Demographyc description

    2008-2023

  • Physiologic description

    2008-2023

  • Wound and abdominal exploration

    2008-2023

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All penetrating trauma patients admitted in the emergency department.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ana María González Castillo, PhD

    Hospital del Mar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana María González Castillo, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 29, 2024

Study Start

March 15, 2024

Primary Completion

December 15, 2024

Study Completion

March 15, 2025

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share