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

May 9, 2023 updated by: Carmine Cristiano Di Gioia, Azienda Ospedaliero-Universitaria di Modena

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
All patients will be seen by the emergency physician within 6 hours of admission to the emergency department.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The hospital length of stay
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.
The mortality rate
Time Frame: 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
Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliero-Universitaria di Modena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBOCUS2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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