NCT03226665

Brief Summary

Small bowel obstruction (SBO) is a common presentation to the emergency department (ED) and represents 15% of hospital admissions for acute abdominal complaints. Plain radiography, although traditionally recommended as the initial diagnostic imaging modality of choice, has a sensitivity of only 59% to 77%. When clinical and radiographic assessment is indeterminate, computed tomography (CT) becomes the test of choice due to its superior resolution and increased ability to identify both obstruction and its aetiology Aim: this is a prospective study in a sample of patients presenting to the emergency department (ED) with abdominal pain, vomiting, or other symptoms suggestive of a SBO (history of previous surgeries, constipation, abnormal bowel sounds, and abdominal distention). Patients will be evaluated with US prior to x-ray and CT, with possible diagnostic confirms by endoscopy or surgery.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

July 14, 2017

Last Update Submit

January 8, 2018

Conditions

Keywords

obstructionsmall bowelultrasound

Outcome Measures

Primary Outcomes (1)

  • Moreover, which clue, if any, such as anaemia, CRP, NLR, hypotension, could reinforce the need of US intestinal study.

    According to the emergency referral protocols, patients that are assessed at the triage phase as likely to have any abdominal acute disease, including bowel occlusion, are preliminary studied by laboratory concurrently with the record of vital signs (blood pressure, electrocardiogram, pulse oxymetry). These information will be available during the actual visit of the Abdominal ultrasound in emergency may show fluid effusion, hemorrhagic or not, liver and/or gallbladder disease, spleen disease - possible leakage -, vascular disease (such as aneurism), inflammatory disease (Appendicitis, diverticulitis, Crohn's disease), masses and nodes (tumors, parasitic, others) and bowel occlusion . Clues, (anaemia, increased C-Reactive Protein, electrolyte abnormalities, clinical symptoms, hypotension) may reinforce the opportunity of US intestinal study, according also to the concordance with the subsequent confirmatory procedures.

    12 months

Interventions

ultrasoundDIAGNOSTIC_TEST

definition of prevalence of US detected obstruction in patients referred to an emergency facilities with symptoms potentially suggestive for such diagnosis. Moreover, which clue, if any, could reinforce the need of US intestinal study, such as anaemia, CRP, NLR, hypotension. This information is not yet available elsewhere. Moreover, in this context, sensitivity and specificity of ultrasound vs. confirm by CT and other procedures will make more sense and will be consequently assessed.

Also known as: plain x-rays, computerized tomography

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients referred to the emergency facility with the clinical suspicion - before any imaging procedure - of small bowel obstruction

You may qualify if:

  • acute abdominal pain
  • clinical clues of small bowel obstruction (SBO) according to symptoms and physical examination in the clinic

You may not qualify if:

  • pregnancy
  • post-surgical patients
  • Trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Guttman J, Stone MB, Kimberly HH, Rempell JS. Point-of-care ultrasonography for the diagnosis of small bowel obstruction in the emergency department. CJEM. 2015 Mar;17(2):206-9. doi: 10.2310/8000.2014.141382.

  • Taylor MR, Lalani N. Adult small bowel obstruction. Acad Emerg Med. 2013 Jun;20(6):528-44. doi: 10.1111/acem.12150.

  • Jang TB, Schindler D, Kaji AH. Bedside ultrasonography for the detection of small bowel obstruction in the emergency department. Emerg Med J. 2011 Aug;28(8):676-8. doi: 10.1136/emj.2010.095729. Epub 2010 Aug 22.

MeSH Terms

Conditions

Intestinal ObstructionBites and Stings

Interventions

UltrasonographyTomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage Interpretation, Computer-AssistedRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Guglielmo Trovato, MD

    AOVE Policlininico unict

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine - Research Project Planning Unit

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 24, 2017

Study Start

November 1, 2018

Primary Completion

April 30, 2019

Study Completion

June 30, 2019

Last Updated

January 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share