USBOW: Ultrasound Emergency Diagnosis of Small Bowel Obstruction

Sponsor
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele (Other)
Overall Status
Unknown status
CT.gov ID
NCT03226665
Collaborator
(none)
50
7.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ultrasound

Detailed Description

Primary outcome:

Our objective was to study the accuracy of emergency medicine bedside ultrasonography and in patients with suspected small bowel obstruction (SBO).

Secondary outcome:

assess the usefulness of the history and physical examination in the prediction of diagnosis

US Diagnostic criteria:
  • Bowel lumen diameter >2.5cm

  • Wall thickness > 4 mm

  • Decreased/absent peristalsis

  • Back/forth stool movements

  • Free fluid

Methods The study is based on the assessment of all consecutive patients (19-75 years) presenting in the emergency department of Policlinico VE of the University of Catania (or to other affiliated Hospitals, such as Cannizzaro and/or Ragusa hospitals), which show clinical clues of small bowel obstruction (SBO). The criterion of enrolment is the casual referral to few previously identified physicians, skilled in TUS procedures and which accepted to take part to this study.

The most similar study on this topic demonstrates an extremely high accuracy of US in the diagnosis of intestinal obstruction, so that no actual power analysis can be done. The rationale of the present prospective study is the 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, such as anaemia, CRP, NLR, hypotension, could reinforce the need of US intestinal study.

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.

The secondary reason of this investigation is the attempt to detect which are the prevalence and the feature of under-diagnosis or over-diagnosis by US vs. the actual condition.

IMPLEMENTATION. This is a medium-term pilot study, non-interventional, which can be performed better as a single centre investigation, with few skilled and committed emergency physicians, than as a multicentre study, which would have the possible bias of relying on a mosaic or on scarcely skilled or motivated MDs.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ultrasound Emergency Diagnosis of Small Bowel Obstruction. An Observational Study
Anticipated Study Start Date :
Nov 1, 2018
Anticipated Primary Completion Date :
Apr 30, 2019
Anticipated Study Completion Date :
Jun 30, 2019

Outcome Measures

Primary Outcome Measures

  1. Moreover, which clue, if any, such as anaemia, CRP, NLR, hypotension, could reinforce the need of US intestinal study. [12 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • acute abdominal pain

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

Exclusion Criteria:
  • pregnancy

  • post-surgical patients

  • Trauma

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

Investigators

  • Study Director: Guglielmo Trovato, MD, AOVE Policlininico unict

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guglielmo Trovato, MD, PhD, Professor of Medicine - Research Project Planning Unit, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
ClinicalTrials.gov Identifier:
NCT03226665
Other Study ID Numbers:
  • USBOW
First Posted:
Jul 24, 2017
Last Update Posted:
Jan 9, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Guglielmo Trovato, MD, PhD, Professor of Medicine - Research Project Planning Unit, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 9, 2018