Clinical trial NCT05864378: POCUS for Small Bowel Obstruction in the ED: a Retrospective Study
Official title: The Impact of Point-of-care Ultrasound on the Diagnosis and Management of Small Bowel Obstruction in the Emergency Department: a Retrospective Observational Single-center Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small Bowel Obstruction
Point of Care Ultrasound
Keywords: POCUS
SBO
Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be divided into two groups:

1. The POCUS group: patients who were evaluated by ED physicians who perform POCUS intestinal loops examination as part of their clinical practice
2. The non-POCUS group: patients who were evaluated by ED physicians who do not perform POCUS intestinal loops examination for any reason.

Brief summary: This study protocol aims to evaluate the impact of point-of-care ultrasound (POCUS) on the diagnosis and management of small bowel obstruction (SBO) in the emergency department (ED). SBO is a potentially life-threatening condition that requires prompt diagnosis and management. Currently, the diagnosis of SBO is based on clinical evaluation and imaging tests, including plain abdominal radiography and computed tomography (CT) scan. POCUS is a bedside imaging technique that is rapid, non-invasive, repeatable, cost-effective and radiation-free, and can provide valuable information for the diagnosis and management of SBO. The primary objective of this study is to compare the time to diagnosis of SBO between patients who undergo POCUS intestinal loops examination and those who do not undergo POCUS in the ED. The secondary objectives include comparing the hospital length of stay, the rate of surgical intervention, the rate of complications, and the mortality rate between the two groups. This is a monocentric retrospective cohort study that will include all adult patients (\> 18 years old) who presented to the ED with suspected SBO. The study population will be divided into two groups: the POCUS group and the non-POCUS group. The sample size calculation will be based on the assumption of a 30% reduction in the time to diagnosis of SBO in the POCUS group compared to the non-POCUS group, with a power of 80%. The results of this study may provide more robust evidence on the diagnostic accuracy and impact of POCUS for SBO in the ED.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Clinical suspicion of SBO based on history and physical examination
* Plain abdominal radiography (AXR) or CT scan performed in the ED

Exclusion Criteria:

* Pregnancy
* Known bowel obstruction
* Previous abdominal surgery within 30 days
* Refusal or inability to consent

Primary outcomes:
measure: Time to diagnosis of SBO by POCUS or CT scan
timeFrame: All patients will be seen by the emergency physician within 6 hours of admission to the emergency department.
Secondary outcomes:
measure: The hospital length of stay
timeFrame: Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.
measure: The rate of surgical intervention
timeFrame: Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.
measure: The rate of complications
timeFrame: Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.
measure: The mortality rate
timeFrame: Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.
Other outcomes:
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