Contribution of Point of Care Ultrasound by the Emergency Physician to Rule Out the Small Bowel Obstruction: a Diagnostic, Multicenter Study

NCT06803628 | Recruiting

• 1 other identifier: RC24_0388
• Study Type: observational
• Target: 667
• Locations: 1 country
• Sites: 18

Brief Summary

Small Bowel Obstruction (SBO) is a frequent pathology in the emergency department (ED). Diagnosis is currently based on abdominal CT scan (CT). Moreover, CT is warranted to determine the therapeutic strategy in patients with SBO which could include medical treatment; surgical intervention or both. However, CT is associated with drawbacks such as radiation exposure, increased cost and ED length-of-stay. In a prospective observational study, a SBO was excluded by CT in 45% \[95%CI: 37-53\] of patients. There is, thus, a need for improving the appropriateness of CT-scan for suspected SBO. A recent meta-analysis showed that Point of care ultrasound (POCUS) had a good diagnostic accuracy (sensitivity 83% \[95%CI 71.7%-90.4%\]), specificity 93% \[95%CI 55.3%-99.3%\]). Another meta-analysis found rather similar results (sensitivity 83% \[(95% CI 89.0% to 94.7%\], specificity 96,6% \[95% CI 88.4% to 99.1%\]). In order to improve the negative predictive value of POCUS for its implementation as a rule-out strategy, CHU of Nantes emergency unit studied the combination of POCUS with Gestalt pre-test probability of SBO determined by the emergency physician. This SBO probability classified the patients as low, moderate or high risk of SBO. In patients with low or moderate Gestalt probability, CHU of Nantes emergency unit found that this combined strategy had a sensitivity of 100% \[95% CI: 88-100\] and NPV 100% \[92-100%\]. By (i) focusing on patients with a low or moderate Gestalt clinical probability and (ii) increasing the number of patients included, CHU of Nantes emergency unit intends to demonstrate that POCUS is able to exclude SBO in this population. This would avoid unnecessary CT and thus lower costs, ED length-of-stay and hospital radiologists workload. A POCUS will be performed followed by a CT (gold standard). The main objective will be the ability of POCUS to rule-out SBO in patients with low or moderate Gestalt clinical probability.

Conditions

Small Bowel Obstruction

Keywords

Small bowel obstruction; Point of care ultrasound; Emergency Medicine

Outcome Measures

Primary Outcomes (1)

• Estimate the ability of POCUS to rule-out SBO in patients with low or moderate Gestalt clinical probability

  Evaluation of the negative predictive value (NPV) of point of care ultrasound (POCUS) in patients with suspected Small Bowel Obstruction (SBO) (number of patients with negative POCUS in patients without SBO according to the CT (gold standard) divided by total patients with negative POCUS)

  Day 1

Secondary Outcomes (9)

• 1/ Diagnostic accuracy of POCUS for the diagnosis of SBO

  Day 1

• 2/ Estimation of time between POCUS and CT report

  Day 1

• 3a/ Description of "false negative" (exclusion of SBO diagnosis by POCUS, but diagnosis of SBO by CT)

  Day 1

• 3b/ Description of "false positive" (SBO diagnosis by POCUS, but diagnosis of SBO excluded by CT)

  Day 1

• 4/ Description of patients with a final diagnosis other than SBO

  Day 1

Study Arms (1)

POCUS

Point of care ultrasound in Small bowel obstruction in Emergency Medicine,

Other: Point of care ultrasound

Interventions

Point of care ultrasound OTHER

OCCLUS-POCUS will include patients with suspected SBO, with low or moderate Gestalt probability who meet the inclusion criteria During the patient's visit to the ED, the investigating physician will present the study and the importance of evaluating the value of POCUS in the diagnosis of exclusion of SBO. Once oral non-opposition to the study has been obtained, the participation of the patient lasts 28 days. POCUS is performed only for patients with low or moderate Gestalt probability. It will be performed by trained emergency physicians (EP) using a curvilinear probe . After POCUS realization, the EP will: * determine if there is presence or absence of SBO. * collect POCUS duration, difficulty and investigator's characteristics. * Realization of CT which will be the gold standard for SBO presence or absence. * The study protocol procedure ends when the report of the CT is available and the physician establish its diagnosis. * The study ends at D28 with a phone call

POCUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected SBO, with low or moderate Gestalt probability and who meet the inclusion criteria (and without any non inclusion criteria)

You may qualify if:

• Major patient (age \> 18 years old), no upper limit
• Patient admitted to the ED with suspected SBO (abdominal pain, vomiting, cessation of gas and feces...)
• Low or moderate pretest Gestalt clinical probability
• Patient able to understand protocol and express agreement
• Oral non-opposition given

You may not qualify if:

• Patient under legal guardianship
• Pregnant women
• Nursing mothers
• Patient who does not speak or understand French
• Patient without a health insurance plan
• Patient who already had imaging confirming the diagnosis
• Patient who participates simultaneously in any interventional study focused on abdominal pain before POCUS and CT realization

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (18)

Chu Clermont-Ferrand Hopital Gabriel Montpied

Clermont-Ferrand, France, 63100, France

RECRUITING

Ghem Groupe Hospitalier Eaubonne Montmorency Simone Veil

Eaubonne, France, 95600, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, France, 85925, France

RECRUITING

CHD Vendée, Luçon

Luçon, France, 85407, France

RECRUITING

Ap-Hm Hopital La Timone

Marseille, France, 13005, France

RECRUITING

Hôpital Nord

Marseille, France, 13015, France

NOT YET RECRUITING

Ghsif Groupe Hospitalier Sud Ile de Franc _ Ch Melun

Melun, France, 77000, France

RECRUITING

CHD Vendée, Montaigu

Montaigu, France, 85600, France

RECRUITING

CHU Nantes

Nantes, France, 44000, France

RECRUITING

Le Confluent

Nantes, France, 44200, France

RECRUITING

CHU CAREMEAU - Nimes

Nîmes, France, 30029, France

RECRUITING

AP-HP Est Parisien _ ST-ANTOINE

Paris, France, 75012, France

RECRUITING

P-HP Paris Centre - COCHIN

Paris, France, 75014, France

RECRUITING

Chru Poitiers

Poitiers, France, 86021, France

RECRUITING

CH MEMORIAL - Saint Lô

Saint-Lô, France, 50009, France

RECRUITING

CH Saint-Nazaire

Saint-Nazaire, France, 44600, France

RECRUITING

Groupe Hospitalier Selestat Obernai (Ghso)

Sélestat, France, 67600, France

RECRUITING

Hopital PURPAN CHU Toulouse

Toulouse, France, 31300, France

RECRUITING

Central Study Contacts

Philippe LE CONTE Professor LE CONTE, Professor

CONTACT

0240083934; philippe.leconte@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): March 10, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (18)