Small Bowel Obstruction Clinical Trial
Official title:
Point of Care Ultrasound for Suspected Small Bowel Obstruction in the Emergency Department
NCT number | NCT02190981 |
Other study ID # | 615362-1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2014 |
Est. completion date | February 2019 |
Verified date | April 2019 |
Source | WellSpan Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary purpose of this study is to determine the accuracy of ultrasound in diagnosing
small bowel obstruction in emergency department patients, as compared to the criterion
standards of computed tomography, operative reports, or discharge diagnosis.
The secondary purposes of the study include evaluation of the effect of ultrasound for small
bowel obstruction on the patient length of stay in the emergency department and the
diagnostic utility of specific ultrasound findings in the diagnosis of small bowel
obstruction. The study will also examine the inter-rater agreement between point-of-care
sonographers' interpretation and blinded reviewers' interpretation of the ultrasound images.
Status | Completed |
Enrollment | 217 |
Est. completion date | February 2019 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years of age or greater - Abdominal pain with clinical suspicion for small bowel obstruction Exclusion Criteria: - Less than 18 years of age - Lack of decision-making capacity or cannot provide consent - Pregnancy - Prisoners |
Country | Name | City | State |
---|---|---|---|
United States | University of California Irvine Medical Center | Orange | California |
United States | Christana Hospital | Wilmington | Delaware |
United States | Wellspan Health York Hospital | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
WellSpan Health | Christiana Care Health Services, University of California, Irvine |
United States,
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. — View Citation
Ko YT, Lim JH, Lee DH, Lee HW, Lim JW. Small bowel obstruction: sonographic evaluation. Radiology. 1993 Sep;188(3):649-53. — View Citation
Ogata M, Mateer JR, Condon RE. Prospective evaluation of abdominal sonography for the diagnosis of bowel obstruction. Ann Surg. 1996 Mar;223(3):237-41. — View Citation
Suri S, Gupta S, Sudhakar PJ, Venkataramu NK, Sood B, Wig JD. Comparative evaluation of plain films, ultrasound and CT in the diagnosis of intestinal obstruction. Acta Radiol. 1999 Jul;40(4):422-8. — View Citation
Taylor MR, Lalani N. Adult small bowel obstruction. Acad Emerg Med. 2013 Jun;20(6):528-44. doi: 10.1111/acem.12150. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic Accuracy of Point-of-care Ultrasound for Small Bowel Obstruction | The performance of point-of-care ultrasound for small bowel obstruction will be evaluated by comparing each ultrasound to the criterion standard of computed tomography (CT) for each enrolled patient. If a CT is not obtained, then operative report/findings or discharge diagnosis will be used as the criterion standard to which the ultrasound will be compared. Using the criterion standard as the definitive diagnosis for each patient (i.e. presence or absence of small bowel obstruction), each ultrasound will be classified as a true positive, true negative, false positive or false negative. This data will be used to calculated the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of point-of-care ultrasound for the diagnosis of small bowel obstruction. |
2 years | |
Secondary | Incidence/Likelihood Ratios of Specific Sonographic Findings of Small Bowel Obstruction | Specific sonographic findings include: Small bowel diameter >25 mm "To-and-Fro" peristalsis Small bowel wall edema Presence of intrabdominal free fluid Presence of sonographic transition point (defined as the location between dilated small bowel proximal to the obstruction and decompressed small bowel distal to the obstruction) |
2 years | |
Secondary | Inter-rater Agreement | The study will quantify the rate of inter-rater agreement between the clinician performing the point-of-care ultrasound and a blinded reviewer of the ultrasound images. | 2 years | |
Secondary | Patient Length of Stay/Time to Disposition | The study will measure the time to disposition of ED patients undergoing a point of care ultrasound for small bowel obstruction and determine how the ultrasound effects time to patient disposition. | 2 years |
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