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

NCT ID: NCT05864378

Last Updated: 2023-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Small Bowel Obstruction Point of Care Ultrasound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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The POCUS group

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

No interventions assigned to this group

The non-POCUS group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria di Modena

OTHER

Sponsor Role lead

Responsible Party

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Carmine Cristiano Di Gioia

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Carmine Cristiano Di Gioia

Role: CONTACT

+39 3493812503

Other Identifiers

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SBOCUS2023

Identifier Type: -

Identifier Source: org_study_id

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