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Recruiting NCT06803628

NCT06803628 Contribution of Point of Care Ultrasound by the Emergency Physician to Rule Out the Small Bowel Obstruction: a Diagnostic, Multicenter Study

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Clinical Trial Summary
NCT ID NCT06803628
Status Recruiting
Phase
Sponsor Nantes University Hospital
Condition Small Bowel Obstruction
Study Type OBSERVATIONAL
Enrollment 667 participants
Start Date 2025-03-10
Primary Completion 2027-03-10

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Point of care ultrasound

Eligibility Fast-Check

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 667 participants in total. It began in 2025-03-10 with a primary completion date of 2027-03-10.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

Inclusion Criteria: 1. Major patient (age \> 18 years old), no upper limit 2. Patient admitted to the ED with suspected SBO (abdominal pain, vomiting, cessation of gas and feces...) 3. Low or moderate pretest Gestalt clinical probability 4. Patient able to understand protocol and express agreement 5. Oral non-opposition given Exclusion Criteria: 1. Patient under legal guardianship 2. Pregnant women 3. Nursing mothers 4. Patient who does not speak or understand French 5. Patient without a health insurance plan 6. Patient who already had imaging confirming the diagnosis 7. Patient who participates simultaneously in any interventional study focused on abdominal pain before POCUS and CT realization

Contact & Investigator

Central Contact

Philippe LE CONTE Professor LE CONTE, Professor

✉ philippe.leconte@chu-nantes.fr

📞 0240083934

Frequently Asked Questions

Who can join the NCT06803628 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Small Bowel Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06803628 currently recruiting?

Yes, NCT06803628 is actively recruiting participants. Contact the research team at philippe.leconte@chu-nantes.fr for enrollment information.

Where is the NCT06803628 trial being conducted?

This trial is being conducted at Clermont-Ferrand, France, Eaubonne, France, La Roche-sur-Yon, France, Luçon, France and 11 additional locations.

Who is sponsoring the NCT06803628 clinical trial?

NCT06803628 is sponsored by Nantes University Hospital. The trial plans to enroll 667 participants.

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