Penetrating Abdominal TraumaPAT-HMARNCT06228261
Critical Analysis of the Results in the Management of Penetrating Abdominal Trauma in the Past Fifteen Years.
An observational study of Penetrating Abdominal Trauma, run by Hospital del Mar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Penetrating Abdominal Trauma
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 15 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a penetrating trauma in the neck admitted in Hospital del Mar from 2008 to 2023.
Who may be able to join
- All penetrating trauma patients admitted in the emergency department.
Who cannot join
- All patients with any other diagnostic different from penetrating trauma
- Blunt trauma patients admitted in the emergency department
Trial locations and contacts
No sites are listed yet.
About this study
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?
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.
Read the 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.
- Conditions
- Penetrating Abdominal Trauma
- Keywords
- Penetrating Trauma, Trauma surgery, Explorative laparoscopy, Trauma laparotomy, eFAST
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
The main outcome measure was the total of complications in patients with a penetrating abdominal trauma assessed by the Clavien-Dindo Classification.
Measured: 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.
Measured: 2008-2023
Secondary outcomes (4)
Explorations
To describe the explorations that has been ordered: eFAST, CT Scan, explorative laparoscopy or laparotomy.
Measured: 2008-2023
Demographyc description
Description of the age and gender (Male / Female)
Measured: 2008-2023
Physiologic description
Description of the vitals at arrival (bates per minute, blood pressure)
Measured: 2008-2023
Wound and abdominal exploration
Description of the wound: bleeding, longitude, number of wounds and the abdominal explorations: peritonism or no peritonism.
Measured: 2008-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start15 Mar 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penetrating Abdominal TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana María González Castillo, Hospital del Mar
- Investigators
- Ana María González Castillo, PhD, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228261
- Sponsor's protocol ID
- Penetrating abdotrauma HMAR
- Acronym
- PAT-HMAR
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT06228261
- Acronym / sponsor ID
- PAT-HMAR / Penetrating abdotrauma HMAR
- Conditions
- Penetrating Abdominal Trauma
- Keywords
- Penetrating Trauma, Trauma surgery, Explorative laparoscopy, Trauma laparotomy, eFAST
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a penetrating trauma in the neck admitted in Hospital del Mar from 2008 to 2023.
Key inclusion criteria (1 listed)
- All penetrating trauma patients admitted in the emergency department.
Key exclusion criteria (2 listed)
- All patients with any other diagnostic different from penetrating trauma
- Blunt trauma patients admitted in the emergency department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complications
Time frame: 2008-2023
The main outcome measure was the total of complications in patients with a penetrating abdominal trauma assessed by the Clavien-Dindo Classification.
Mortality
Time frame: 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.
4 secondary outcomes
Explorations
Time frame: 2008-2023
Demographyc description
Time frame: 2008-2023
Physiologic description
Time frame: 2008-2023
Wound and abdominal exploration
Time frame: 2008-2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana María González Castillo, PhD principal investigator
Hospital del Mar
Questions about this trial
What is this clinical trial studying?
An observational study of Penetrating Abdominal Trauma, run by Hospital del Mar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana María González Castillo, PhD (+34665126866, amgonzalezcastillo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 2008-2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.