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Small Bowel ObstructionOCCLUS-POCUSNCT06803628

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

An observational study of Small Bowel Obstruction, run by Nantes University Hospital at 18 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Bowel Obstruction
What is being tested?
Point of care ultrasound
Type of treatment
Pill or oral medicine
How many people
667 participants
Where
18 sitesFrance
Study dates
10 Mar 2025to 10 Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Philippe LE CONTE Professor LE CONTE, Professor contact

0240083934 ext. +33

philippe.leconte@chu-nantes.fr

18 sites in 1 country

France18 sites, 17 recruiting
  • Chu Clermont-Ferrand Hopital Gabriel Montpied

    Clermont-Ferrand, France, 63100

    Christophe Perrier, Doctor, 04 73 754 754 ext. +33, cperrier@chu-clermontferrand.fr

    Christophe PERRIER, Doctor

    Recruiting
  • Ghem Groupe Hospitalier Eaubonne Montmorency Simone Veil

    Eaubonne, France, 95600

    Maxime GAUTIER, Doctor, 01 34 06 67 55 ext. +33, maxime.gautier@ch-simoneveil.fr

    Maxime GAUTIER, Doctor

    Recruiting
  • CHD Vendée

    La Roche-sur-Yon, France, 85925

    François BRAU, Doctor, 02 51 44 61 61 ext. +33, francois.brau@ght85.fr

    François BRAU, Doctor

    Recruiting
  • CHD Vendée, Luçon

    Luçon, France, 85407

    François BRAU, Doctor, 02 51 44 62 05 ext. +33, francois.brau@ght85.fr

    François BRAU, Doctor

    Recruiting
  • Ap-Hm Hopital La Timone

    Marseille, France, 13005

    Thibaut MARKARIAN, Doctor, 04 91 38 00 00 ext. +33, thibaut.markarian@ap-hm.fr

    Thibaud MARKARIAN, Doctor

    Recruiting
  • Hôpital Nord

    Marseille, France, 13015

    Withdrawn
  • Ghsif Groupe Hospitalier Sud Ile de Franc _ Ch Melun

    Melun, France, 77000

    Yousra GUETARI, Doctor, 01 81 74 24 03 ext. +33, yousra.guetari@ghsif.fr

    Yousra GUETARI, Doctor

    Recruiting
  • CHD Vendée, Montaigu

    Montaigu, France, 85600

    François BRAU, Doctor, 02 51 44 62 05 ext. +33, francois.brau@ght85.fr

    François BRAU, Doctor

    Recruiting
  • CHU Nantes

    Nantes, France, 44000

    Philippe LE CONTE, Professor, +33240084654 ext. +33, philippe.leconte@chu-nantes.fr

    Philippe LE CONTE, Professor

    Recruiting
  • Le Confluent

    Nantes, France, 44200

    Christophe BERRANGER, Doctor, 02 28 25 56 51 ext. +33, christophe.berranger@groupeconfluent.fr

    Christophe BERRANGER, Doctor

    Recruiting
  • CHU CAREMEAU - Nimes

    Nîmes, France, 30029

    Laura MERCIER, Doctor, 04 66 68 30 50 ext. +33, laura.mercier@chu-nimes.fr

    Laura MERCIER, Doctor

    Recruiting
  • AP-HP Est Parisien _ ST-ANTOINE

    Paris, France, 75012

    Agathe BEAUVAIS, Doctor, 01 71 97 00 60 ext. +33, agathe.beauvais@aphp.fr

    Agathe BEAUVAIS, Doctor

    Recruiting
  • P-HP Paris Centre - COCHIN

    Paris, France, 75014

    Jérôme BOKOBZA, Doctor, 01 58 41 27 22 ext. +33, Jerome.bokobza@aphp.fr

    Jérôme BOKOBZA, Doctor

    Recruiting
  • Chru Poitiers

    Poitiers, France, 86021

    Jérémy GUENEZAN, Doctor, 05 49 44 44 44 ext. +33, jeremy.guenezan@chu-poitiers.fr

    Jérémy GUENEZAN, Doctor

    Recruiting
  • CH MEMORIAL - Saint Lô

    Saint-Lô, France, 50009

    Félix AMIOT, Doctor, 02 33 06 30 47 ext. +33, felix.amiot@ch-stlo.fr

    Félix AMIOT, Doctor

    Recruiting
  • CH Saint-Nazaire

    Saint-Nazaire, France, 44600

    Sylvain AMIMER, Doctor, 02 72 27 81 87 ext. +33, s.amimer@ch-saintnazaire.fr

    Sylvain AMIMER, Doctor

    Recruiting
  • Groupe Hospitalier Selestat Obernai (Ghso)

    Sélestat, France, 67600

    Mathieu OBERLIN, Doctor, 03 88 20 50 60 ext. +33, mathieu.oberlin@ghso.fr

    Mathieu OBERLIN, Doctor

    Recruiting
  • Hopital PURPAN CHU Toulouse

    Toulouse, France, 31300

    Marion BUREL, Doctor, 05 61 32 22 71 ext. +33, burel.m@chu-toulouse.fr

    Marion BUREL, Doctor

    Recruiting

Other trials in France

About this study

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.

Read more

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.

Read the detailed description

Small Bowel Obstruction (SBO) is a frequent pathology, leading to admissions to emergency departments (ED). Diagnosis is currently based on an abdominal CT scan (CT). However, CT is associated with drawbacks such as radiation exposure, increased cost and ED length-of-stay.

A recent meta-analysis including 1178 patients 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 with 433 patients, found rather similar results: sensitivity 83% [95% CI 89.0% to 94.7%], specificity 96,6% [95% CI 88.4% to 99.1%]).

Since CT is almost warranted to guide the treatment strategy, which could include surgery, medical treatment or both, CHU of Nantes emergency unit explored a different approach focusing on POCUS rule-out ability. This study also introduced the notion of SBO Gestalt probability which is a global clinical evaluation by the physician. Gestalt probability has mainly been explored in patients with suspected pulmonary embolism and was found as effective as clinical prediction rules. It is used in the routine clinical evaluation of patient with suspicion of pulmonary embolism. When applied to patients with SBO suspicion, the physician chooses between low, moderate or high risk of SBO. Based on CT results, prevalence of SBO based on Gestalt probability were 21%, 45% and 87% in the low, moderate and high risks, respectively.

Our team studied POCUS with the following items that were searched in the whole abdomen divided into nine zones: dilated incompressible fluid-filled intestinal loop (\>25 mm) with back-and-forth fluid movement. When at least one of these signs was present in one zone, the SBO was highly suspected. As it was an observational study, a CT was performed in all patients and was the gold standard. This approach was associated with a POCUS sensitivity in the whole population of 99% [95% CI: 93-99.8] [2]. POCUS would thus have a role in patients with low and moderate SBO risks because the prevalence of SBO was major in the high risk Gestalt probability category of patients, and thus CT is the only imaging needed in these latter. Furthermore, in patients with low or moderate probability, the sensitivity was 100% [95% CI: 88-100] In previous studies, the sensitivity was not able to exclude SBO with sufficient security since the lower 95% confidence interval margin was near 90%. By (i) focusing on patients with a low or moderate clinical Gestalt probability and (ii) increasing the number of patients, CHU of Nantes emergency unit intends to demonstrate that POCUS should be able to safely exclude SBO in this population.

In case of positive results, the diagnostic strategy in case of SBO suspicion could be modified in: firstly, assess the clinical Gestalt probability; secondly perform a POCUS in patients with low or moderate Gestalt probability and thirdly, prescribe a CT only for patients with high clinical probability or presence of POCUS signs of SBO. This would avoid unnecessary CT and thus lower patient's.

exposure, costs, ED length-of-stay and radiologist workload. A study performed in the USA simulated a POCUS first approach in patients with suspected SBO and found that it could save ED length of stay, radiation and money. In France in 2017, about ¾ of ED were equipped with ultrasound machines and half of the emergency physicians were trained in POCUS. Furthermore, SBO detection is easily performed: in our study, the operator self-assessed ultrasound experience was beginner or intermediate for 59% of patients. In case of positive results, this technique would be largely deployed.

Inclusion criteria will be patients with low or moderate Gestalt clinical probability of SBO. A POCUS will be performed followed by a CT (gold standard). This CT will be realized and interpreted blindly from the POCUS results. The main objective will be the ability of POCUS to rule-out SBO in patients with low or moderate Gestalt clinical probability

Being tested
Point of care ultrasound
Keywords
Small bowel obstruction, Point of care ultrasound, Emergency Medicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Point of care ultrasoundOther

    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
Study groups in NCT06803628
Study groupRoleWhat they receive
POCUSPoint of care ultrasound in Small bowel obstruction in Emergency Medicine,
Receives: Other: Point of care ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Day 1

Secondary outcomes (9)
  1. 1/ Diagnostic accuracy of POCUS for the diagnosis of SBO

    1/ Sensitivity, specificity, positive predictive value of POCUS determined from POCUS and CT results.

    Measured: Day 1

  2. 2/ Estimation of time between POCUS and CT report

    2/ Time between point of care ultrasound and CT report

    Measured: Day 1

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

    3a/ Characteristics associated with false negative (BMI, sex, age, physician\'s experience, physician\'s evaluation of POCUS difficulty on a numerical scale from 0 to 10)

    Measured: Day 1

  4. 3b/ Description of "false positive" (SBO diagnosis by POCUS, but diagnosis of SBO excluded by CT)

    3b/ Characteristics associated with false positive (BMI, sex, age, physician\'s experience, physician\'s evaluation of POCUS difficulty on a numerical scale from 0 to 10)

    Measured: Day 1

  5. 4/ Description of patients with a final diagnosis other than SBO

    4/ Patients' characteristics with other diagnosis than SBO (BMI, sex, age, final diagnosis)

    Measured: Day 1

  6. 5/ Physician's assessment of the POCUS procedure

    5/ Duration in minutes of POCUS and difficulty of clinical POCUS estimated by the operator on a numerical scale named "operator difficulty of clinical POCUS realization" from 0 to 10 (0 being the lower and 10 the higher score)

    Measured: Day 1

  7. 6a/ Physician intention to prescribe CT even if POCUS showed no SBO

    6a/ Number of CT which would have been prescribed for acute abdominal pain

    Measured: Day 1

  8. 6b/ Reason for which CT would have been realized

    6b/ Reason for requesting a CT in spite of exclusion of a diagnosis of SBO (poor echogenicity, lack of confidence in its realization, other diagnostic suspicion requiring a CT scan …)

    Measured: Day 1

  9. 7/ Follow-up of patients

    Phone call at Day 28 to establish the health status in relation to the previous reason for emergency consultation, to know if a second visit to emergency department for same reason within 7 days of primary consultation happened, and/or if another hospitalization within 28 days happened)

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2025
  2. Study start10 Mar 2025
  3. Primary completion10 Mar 2027 (estimated)
  4. Study completion10 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
667 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06803628
Sponsor's protocol ID
RC24_0388
Acronym
OCCLUS-POCUS
Status last verified
May 2026
First submitted
27 Jan 2025
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Papin M, Le Bastard Q, Saignes M, Le Thuaut A, Le Conte P. Contribution of point of care ultrasound for ruling out small bowel obstruction in emergency departments: study protocol of the diagnostic, observational, prospective and multicentre OCCLUS-POCUS study. BMJ Open. 2026 May 28;16(5):e113887. doi: 10.1136/bmjopen-2025-113887.

    PubMed 42209001

Questions about this trial

What is this clinical trial studying?

An observational study of Small Bowel Obstruction, run by Nantes University Hospital at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Philippe LE CONTE Professor LE CONTE, Professor (0240083934 ext. +33, philippe.leconte@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate the ability of POCUS to rule-out SBO in patients with low or moderate Gestalt clinical probability (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06803628, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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