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Clinical Trials/NCT05864378
NCT05864378
Not Yet Recruiting
N/A

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

Azienda Ospedaliero-Universitaria di Modena0 sites230 target enrollmentSeptember 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Small Bowel Obstruction
Sponsor
Azienda Ospedaliero-Universitaria di Modena
Enrollment
230
Primary Endpoint
Time to diagnosis of SBO by POCUS or CT scan
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
February 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carmine Cristiano Di Gioia

Attending physician

Azienda Ospedaliero-Universitaria di Modena

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

Outcomes

Primary Outcomes

Time to diagnosis of SBO by POCUS or CT scan

Time Frame: All patients will be seen by the emergency physician within 6 hours of admission to the emergency department.

The primary outcome will be the time to diagnosis of SBO by POCUS or CT scan, defined as the interval between the ED arrival and the confirmation of SBO by either imaging modality, comparing the two groups.

Secondary Outcomes

  • The hospital length of stay(Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.)
  • The rate of surgical intervention(Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.)
  • The rate of complications(Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.)
  • The mortality rate(Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.)

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