Abdominal Trauma, Follow-up in Abdominal Trauma
Conditions
Keywords
trauma, CT scan, CEUS, follow up, abdominal pseudoaneurism
Brief summary
The researchers aim to study the role of contrast ultrasound in detecting post-traumatic splenic, hepatic, and renal PAs compared with the gold standard of CT with intravenous contrast at different follow-up time points, and whether it can replace CT scan in the follow-up of solid organ injuries
Detailed description
Adult patients (18 years old and above) with proven blunt or penetrating splenic and/or liver and/or renal trauma as shown by a CT scan and classified according to the American Injury Scale American Association for Surgery (AAST) Organ Injury Scale (OIS) with OIS III and above will undergo a follow-up with both a CEUS and CT scan to detect post-traumatic parenchymal pseudoaneurysm within two to five days from injury. Follow-up over five days post-admission will be included if they were performed within the same hospitalization
Interventions
OTHERContrast-enhanced ultrasound
Patients data monitoring with medium- and high-grade trauma to the liver, spleen, and kidney
Sponsors
Niguarda Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients (18 years old and above) with proven blunt or penetrating splenic and/or liver and/or renal trauma as shown by a CT scan and classified according to the American Injury Scale American Association for Surgery (AAST) Organ Injury Scale (OIS) will be included
Exclusion criteria
* minor to 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pseudoaneursim (PA) | up to 5 days post patients admission | In each centre, the coordinator will collect epidemiological, clinical, and surgical data on a case report form (CRF) that will be completed through a questionnaire by accessing a protected database. The protocol for data collection is shown in appendix 1 (attached). The link for accessing the completion of the CRF will be sent by email, to the Main Lead of each participating centre. The main outcome will be the number of post-traumatic Pseudoaneurysms identified with CT scan and CEUS. The sample size for unknown populations has been derived according to the formula N= Z2 x p (1-p)/ e2, setting standard deviation (SD) at 50%, confidence interval at 95%, and Z-score at 1.65. The minimum sample size was 385 patients with a sampling error of ± 5%. |
Countries
Italy
Contacts
CONTACTFrancesco Virdis, MD
Outcome results
None listed