Critical Analysis of the Results in the Management of Pen... | NCT06228261

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

NCT06228261

Sponsor

Hospital del Mar

Status

Unknown status

Last Update Posted

Jan 29, 2024Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Penetrating Abdominal Trauma

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2024Estimated

Primary Completion Date

Dec 15, 2024Estimated

Completion Date

Mar 15, 2025Estimated

First Submitted Date

Jan 18, 2024

First Submission Date that Met QC Criteria

Jan 18, 2024

First Posted Date

Jan 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2024

Last Update Posted Date

Jan 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ana María González Castillo, PhD	Contact	+34665126866		amgonzalezcastillo@gmail.com

Overall Officials

Name	Affiliation	Role
Ana María González Castillo, PhD	Hospital del Mar	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided