Contribution of Point of Care Ultrasound by the Emergency Physician to Rule Out the Small Bowel Obstruction: a Diagnostic, Multicenter Study
Recruiting now
Conditions studied: Small Bowel Obstruction
In brief
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 facts
- Study ID
- NCT06803628
- Run by
- Nantes University Hospital
- People needed
- 667
- Starts
- 2025-03-10
- Expected to finish
- 2027-03-10
- Last updated by the study team
- 2026-05-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Hopital PURPAN CHU Toulouse — Toulouse, France, France (enrolling)
- Ghem Groupe Hospitalier Eaubonne Montmorency Simone Veil — Eaubonne, France, France (enrolling)
- CHD Vendée — La Roche-sur-Yon, France, France (enrolling)
- CHD Vendée, Luçon — Luçon, France, France (enrolling)
- Ap-Hm Hopital La Timone — Marseille, France, France (enrolling)
- Chu Clermont-Ferrand Hopital Gabriel Montpied — Clermont-Ferrand, France, France (enrolling)
- Ghsif Groupe Hospitalier Sud Ile de Franc _ Ch Melun — Melun, France, France (enrolling)
- CHD Vendée, Montaigu — Montaigu, France, France (enrolling)
- CHU Nantes — Nantes, France, France (enrolling)
- Le Confluent — Nantes, France, France (enrolling)
- CHU CAREMEAU - Nimes — Nîmes, France, France (enrolling)
- AP-HP Est Parisien _ ST-ANTOINE — Paris, France, France (enrolling)
- P-HP Paris Centre - COCHIN — Paris, France, France (enrolling)
- Chru Poitiers — Poitiers, France, France (enrolling)
- CH MEMORIAL - Saint Lô — Saint-Lô, France, France (enrolling)
- CH Saint-Nazaire — Saint-Nazaire, France, France (enrolling)
- Groupe Hospitalier Selestat Obernai (Ghso) — Sélestat, France, France (enrolling)
- Hôpital Nord — Marseille, France, France
Full record on ClinicalTrials.gov
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