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RECRUITING
NCT06803628

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

667

Start Date

2025-03-10

Completion Date

2027-03-10

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

OTHER

Point of care ultrasound

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

Locations (18)

Chu Clermont-Ferrand Hopital Gabriel Montpied

Clermont-Ferrand, France, France

Ghem Groupe Hospitalier Eaubonne Montmorency Simone Veil

Eaubonne, France, France

CHD Vendée

La Roche-sur-Yon, France, France

CHD Vendée, Luçon

Luçon, France, France

Ap-Hm Hopital La Timone

Marseille, France, France

Hôpital Nord

Marseille, France, France

Ghsif Groupe Hospitalier Sud Ile de Franc _ Ch Melun

Melun, France, France

CHD Vendée, Montaigu

Montaigu, France, France

CHU Nantes

Nantes, France, France

Le Confluent

Nantes, France, France

CHU CAREMEAU - Nimes

Nîmes, France, France

AP-HP Est Parisien _ ST-ANTOINE

Paris, France, France

P-HP Paris Centre - COCHIN

Paris, France, France

Chru Poitiers

Poitiers, France, France

CH MEMORIAL - Saint Lô

Saint-Lô, France, France

CH Saint-Nazaire

Saint-Nazaire, France, France

Groupe Hospitalier Selestat Obernai (Ghso)

Sélestat, France, France

Hopital PURPAN CHU Toulouse

Toulouse, France, France