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SBOCUS: POCUS for Small Bowel Obstruction in the ED: a Retrospective Study

Sponsor
Azienda Ospedaliero-Universitaria di Modena (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05864378
Collaborator
(none)
230
Enrollment
5
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    230 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Feb 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    The POCUS group

    Patients who were evaluated by ED physicians who perform POCUS intestinal loops examination as part of their clinical practice
    The non-POCUS group

    Patients who were evaluated by ED physicians who do not perform POCUS intestinal loops examination for any reason

    Outcome Measures

    Primary Outcome Measures

    1. Time to diagnosis of SBO by POCUS or CT scan [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 Outcome Measures

    1. 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 interval between the ED arrival and the hospital discharge

    2. 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 proportion of patients who underwent laparotomy or laparoscopy for SBO

    3. 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 proportion of patients who developed bowel ischemia, perforation, peritonitis or sepsis during their hospitalization

    4. The mortality rate [Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.]

      The proportion of patients who died during their hospitalization or within 30 days after their ED arrival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Azienda Ospedaliero-Universitaria di Modena

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carmine Cristiano Di Gioia, Attending physician, Azienda Ospedaliero-Universitaria di Modena
    ClinicalTrials.gov Identifier:
    NCT05864378
    Other Study ID Numbers:
    • SBOCUS2023
    First Posted:
    May 18, 2023
    Last Update Posted:
    May 18, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Carmine Cristiano Di Gioia, Attending physician, Azienda Ospedaliero-Universitaria di Modena
    POCUS
    SBO
    Additional relevant MeSH terms:
    Intestinal Obstruction

    Study Results

    No Results Posted as of May 18, 2023