Small Bowel ObstructionSBOCUSNCT05864378
POCUS for Small Bowel Obstruction in the ED: a Retrospective Study
An observational study of Small Bowel Obstruction and Point of Care Ultrasound, run by Azienda Ospedaliero-Universitaria di Modena.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction, Point of Care Ultrasound
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Known bowel obstruction
- Previous abdominal surgery within 30 days
- Refusal or inability to consent
Trial locations and contacts
No sites are listed yet.
About this 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
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.
- Conditions
- Small Bowel Obstruction, Point of Care Ultrasound
- Keywords
- POCUS, SBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnosis of SBO by POCUS or CT scan
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.
Measured: All patients will be seen by the emergency physician within 6 hours of admission to the emergency department.
Secondary outcomes (4)
The hospital length of stay
The interval between the ED arrival and the hospital discharge
Measured: 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
The proportion of patients who underwent laparotomy or laparoscopy for SBO
Measured: 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
The proportion of patients who developed bowel ischemia, perforation, peritonitis or sepsis during their hospitalization
Measured: Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.
The mortality rate
The proportion of patients who died during their hospitalization or within 30 days after their ED arrival
Measured: Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmine Cristiano Di Gioia, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864378
- Sponsor's protocol ID
- SBOCUS2023
- Acronym
- SBOCUS
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05864378
- Acronym / sponsor ID
- SBOCUS / SBOCUS2023
- Conditions
- Small Bowel Obstruction, Point of Care Ultrasound
- Keywords
- POCUS, SBO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy
- Known bowel obstruction
- Previous abdominal surgery within 30 days
- Refusal or inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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 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 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 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Bowel Obstruction and Point of Care Ultrasound, run by Azienda Ospedaliero-Universitaria di Modena.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmine Cristiano Di Gioia (+39 3493812503, cristianodigioia@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.