Obstruction BowelUSBOWNCT03226665
Ultrasound Emergency Diagnosis of Small Bowel Obstruction
An observational study of Obstruction Bowel, run by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele.
Trial 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%. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Obstruction Bowel
- What is being tested?
- ultrasound
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred to the emergency facility with the clinical suspicion - before any imaging procedure - of small bowel obstruction
Who may be able to join
- acute abdominal pain
- clinical clues of small bowel obstruction (SBO) according to symptoms and physical examination in the clinic
Who cannot join
- pregnancy
- post-surgical patients
- Trauma
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Emergency Diagnosis of Small Bowel Obstruction. An Observational Study
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.
Read the 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.
- Conditions
- Obstruction Bowel
- Being tested
- ultrasound
- Keywords
- obstruction, small bowel, ultrasound
- Medical subject headings
- Intestinal Obstruction, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
Also called plain x-rays, computerized tomography
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Nov 2018 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstruction BowelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guglielmo Trovato, MD, PhD, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
- Investigators
- Guglielmo Trovato, MD, Study director, AOVE Policlininico unict
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226665
- Sponsor's protocol ID
- USBOW
- Acronym
- USBOW
- Status last verified
- Jan 2018
- First submitted
- 14 Jul 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25927264Taylor MR, Lalani N. Adult small bowel obstruction. Acad Emerg Med. 2013 Jun;20(6):528-44. doi: 10.1111/acem.12150.
PubMed 23758299Jang 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.
PubMed 20732861
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Emergency Diagnosis of Small Bowel Obstruction. An Observational Study
- ClinicalTrials.gov ID
- NCT03226665
- Acronym / sponsor ID
- USBOW / USBOW
- Conditions
- Obstruction Bowel
- Keywords
- obstruction, small bowel, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera, Universitaria Policlinico Vittorio EmanueleUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to the emergency facility with the clinical suspicion - before any imaging procedure - of small bowel obstruction
Key inclusion criteria (2 listed)
- acute abdominal pain
- clinical clues of small bowel obstruction (SBO) according to symptoms and physical examination in the clinic
Key exclusion criteria (3 listed)
- pregnancy
- post-surgical patients
- Trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundAlso: plain x-rays, computerized tomographydefinition 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. | Diagnostic test | – |
Primary outcome
Moreover, which clue, if any, such as anaemia, CRP, NLR, hypotension, could reinforce the need of US intestinal study.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Results publication: PubMed 25927264Guttman 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.
- Results publication: PubMed 23758299Taylor MR, Lalani N. Adult small bowel obstruction. Acad Emerg Med. 2013 Jun;20(6):528-44. doi: 10.1111/acem.12150.
- Results publication: PubMed 20732861Jang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guglielmo Trovato, MD study director
AOVE Policlininico unict
Questions about this trial
What is this clinical trial studying?
An observational study of Obstruction Bowel, run by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesca TROVATO (+390953781535, trovatofrancesca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moreover, which clue, if any, such as anaemia, CRP, NLR, hypotension, could reinforce the need of US intestinal study. (time frame: 12 months). 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 NCT03226665, which also lists 3 linked publications.
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 9 Jan 2018.