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

Small Bowel Obstruction Clinical Trial

— SBOCUS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05864378
• Other study ID #: SBOCUS2023
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2023
• Source: Azienda Ospedaliero-Universitaria di Modena
• Contact: Carmine Cristiano Di Gioia
• Phone: +39 3493812503
• Email: cristianodigioia[@]icloud.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: February 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Obstruction
• Point of Care Ultrasound
• Small Bowel Obstruction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Modena

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	All patients will be seen by the emergency physician within 6 hours of admission to the emergency department.
Secondary	The hospital length of stay	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.
Secondary	The rate of surgical intervention	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.
Secondary	The rate of complications	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.
Secondary	The mortality rate	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.