- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04896463
Comparative Study of FAST Versus Multidetector CT Scan of the Abdomen in Patients With Abdominal Trauma
Comparative Study of FAST (Focussed Assessment With Sonography in Trauma) Versus Multidetector Computed Tomography (CT) Scan of the Abdomen in Patients With Abdominal Trauma
Study Overview
Status
Intervention / Treatment
Detailed Description
Trauma is a major health problem in every country, regardless of the level of socioeconomic development, associated with high morbidity and mortality as it is still the most frequent cause of death in the first four decades of life.According to the World Health Organization, more than nine people die per minute victimized by trauma, It is costy on the health services more than other diseases with a rate upto 12%.
In Egypt the mortality from road traffic crashes is about 12000 victims per year, with fatality rate of about 42 deaths per 100 000 population. Majority (48%) of them are passengers of motor vehicles. Car accidents in Egypt rose by 17.8% in 2019 with 9,992 compared to 8,480 in 2018 that is announced by The Central Agency For Public Mobilization and Statistics (CAPMAS).
The abdomen is the third most common injured region with surgery required in about 25% of civilian cases.
Abdominal trauma is traditionally classified as either blunt or penetrating (stab or gunshot wounds) which can usually be diagnosed easily and reliably, whereas blunt abdominal trauma is often missed because clinical signs are less obvious.Blunt abdominal injuries predominate in rural areas, while penetrating ones are more frequent in urban settings.
In order to minimize mortality in cases of abdominal trauma, risk factors for mortality needed to be systematically identified and studied. In recent years studies have identified a number of such risk factors, including sex, the length of the interval between abdominal injury and surgery, shock at the time of admission, and cranial injuries.
So appropriate care of the trauma patient entails a multidisciplinary effort that requires speed, efficiency,and proper coordination of the initial care team to make fast rational decisions.In such patient focussed abdominal ultrasonograpghy (FAST) often is the initial imaging examination.
FAST is readily available , low cost, repeatable noninvasive bedside method ,requires minimal preparation time ,and may be performed with mobile equipment that allows greater flexibility in patient positioning than is possible with other imaging modalities .It is also effective in depicting abnormally large intraperitoneal collections of free fluid, which are indirect evidence of a solid organ injury that requires emergency laparotomy.
However, not all clinically important abdominal injuries have associated hemoperitoneum such as those to the bowel , diaphragm, and mesentery. So an initial survey with FAST is often followed by a more thorough examination with multidetector computed tomography (CT) which became the imaging modality of choice in the late 1990s.It is a useful sen e method to detect intraperitoneal free air and intraperitoneal fluid,delineate the extent of solid organ injury,detect retroperitoneal injuries, and help in the decision of conservative nonsurgical therapy.But the adverse effects of it are that it is time consuming procedure and not advisable in hemodynamically unstable patients, moreover it is expensive and carries high risk of radiation exposure when repeated.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Zeinab Salah
- Phone Number: 00201143751762
- Email: zeinabsalah@gmail.com
Study Contact Backup
- Name: Mohammed Abd El-Latief
- Phone Number: 00201001745301
- Email: Latif_mohamed@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (aged ≥18 years).
- Patients exposed to different mechanisms of abdominal trauma whether penetrating such as : stab or gunshot wounds . Or a blunt mechanism of trauma such as:motor vehicle collisions ,falls from height ,assaults ,falling down , falling a heavy object on torso , and sports accidents .
Exclusion Criteria:
- Pregnant females.
- Any patient who undergoes urgent surgical intervention as a primary survey.
- Patient refusal to participate.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The presence (positive FAST) or absence (negative FAST) of intraperitoneal free fluid collection in the four standard views to ascertain accuracy of FAST as regards sensitivity and specificity.
Time Frame: baseline
|
: FAST examination is performed using a mobile US machine with a curvilinear 3.5 to 5 -MHz probe while the patient in a recumbent position and the examiner stands to the right of the patient to obtain the following four standard views:
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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