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

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: Not yet recruiting
• Conditions: Small Bowel Obstruction; Point of Care Ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 230

Contacts and Locations

• Study Contact: Name: Carmine Cristiano Di Gioia; Phone Number: +39 3493812503; Email: cristianodigioia@icloud.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria di Modena

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: POCUS; SBO
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID 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