NCT04848415

Brief Summary

As reported in previous studies, Point-of-Care Ultrasound (POCUS) has good performance for the diagnosis of bowel obstruction even when compared with CT. This inexpensive, radiation-free tool is available in a majority of ED. It is performed at the patient's bedside with immediate results. The learning curve allows Emergency Physicians (EP) to perform this exam after a relative brief training period. The investigators aim to investigate the ability of POCUS performed before CT to exclude the diagnosis of bowel obstruction in patients admitted for abdominal pain.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

February 15, 2021

Last Update Submit

April 16, 2021

Conditions

Keywords

Bowel obstructionComputed tomographyUltrasound

Outcome Measures

Primary Outcomes (1)

  • Negative predictive value of POCUS

    Negative predictive value of POCUS for the diagnosis of bowel obstruction compared with computed tomography result

    Through ED stay, up to 24 hours

Secondary Outcomes (3)

  • Positive predictive value of POCUS for the diagnosis of bowel obstruction

    Through ED stay, up to 24 hours

  • Sensitivity of POCUS for the diagnosis of bowel obstruction

    Through ED stay, up to 24 hours

  • Specificity of POCUS for the diagnosis of bowel obstruction

    Through ED stay, up to 24 hours

Interventions

Patients admitted to the ED with abdominal pain and suspicion of bowel obstruction : realization of a Point-of-Care Ultrasound after clinical exam by the Emergency Physician in charge as a standard of care. Beside usual findings, the investigators will search for signs of bowel obstruction: dilated and incompressible small bowel loop, back-and-forth peristalsis sign. Determination of probability of small bowel obstruction. Realization of a computed tomography in search of small bowel obstruction.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to the ED for abdominal pain and suspicion of bowel obstruction

You may qualify if:

  • Adult patients
  • Abdominal pain
  • Suspected bowel obstruction

You may not qualify if:

  • \- Documented end-of-life precluding CT realization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

February 15, 2021

First Posted

April 19, 2021

Study Start

May 1, 2021

Primary Completion

May 1, 2022

Study Completion

September 1, 2022

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share