Limit Computed Tomography (CT) Scanning in Suspected Renal Colic (Prospective)
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Purpose
Computed tomography (CT) scanning is overused, expensive, and causes cancer. CT scan utilization in the U.S. has increased from an estimated 3 million CTs in 1980 to 62 million per year in 2007. From 2000 through 2006, Medicare spending on imaging more than doubled to $13.8 billion with advanced imaging such as CT scanning largely responsible. CT represents only 11% of radiologic examinations but is responsible for two-thirds of the ionizing radiation associated with medical imaging in the U.S. Recent estimates suggest that there will be 12.5 cancer deaths for every 10,000 CT scans. Renal colic is a common, non-life-threatening condition for which CT is overused. As many as 12% of people will have a kidney stone in their lifetime, and more than one million per year will present to the emergency department (ED). CT is now a first line test for renal colic, and is very accurate. However, 98% of kidney stones 5mm or smaller will pass spontaneously, and CT rarely alters management. A decision rule is needed to determine which patients with suspected renal colic require CT. While the signs and symptoms of renal colic have been shown to be predictable, no rule has yet been rigorously derived or validated to guide CT imaging in renal colic. A subset of patients with suspected renal colic may have a more serious diagnosis or a kidney stone that will require intervention; however the investigators maintain that clinical criteria, point of care ultrasound and plain radiography (when appropriate), will provide a more comparatively effective and safer approach by appropriately limiting imaging.
| Condition |
|---|
|
Renal Colic Flank Pain Back Pain |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Validation of a Decision Rule to Limit CT Scanning in Suspected Renal Colic |
- Ultra Low Dose vs Regular CT Scans [ Time Frame: Baseline-90 Days ] [ Designated as safety issue: No ]both the CT results and the follow-up documentation will be reviewed by two separate MD observers who are blinded to both the predictor variables and the outcome of the decision rule. CT results will be categorized as defined above, and intervention as defined above will either be considered present (immediate or delayed) or absent based on follow-up documentation. In the case where there is a discrepancy in the categorization of CT or intervention, a third reviewer will be used as a tie-breaker, with discussion amongst all parties to reach a consensus if this is not clear.
| Enrollment: | 635 |
| Study Start Date: | May 2011 |
| Study Completion Date: | March 2014 |
| Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The target population will be all patients aged 18 or above presenting to the Yale New Haven Hospital (YNHH) ED and Shoreline Medical Center (SMC) ED for whom a FPP CT scan is ordered by the treating physician for suspected renal colic. A total of 800-1000 patients will be enrolled over a 1.5 year period 6-2011 to 1-2013, matching the sex/race/ethnicity makeup of that found for the retrospective study.
The population of the primary catchment area for YNHH is 350,000 and includes a diverse ethnic and cultural mix. Women and minorities are strongly represented in the population. Women represent approximately 51% of the ED population. The racial mix is approximately 50% White, not of Hispanic Origin; 33% Black, not of Hispanic Origin, 15% Hispanic; 1% Asian and 1% other. The ethnicity of SMC patients is mostly White and 54% female.
Inclusion Criteria:
-
Patients who present to the adult YNHH ED and Shoreline Medical Center SMC ED who are
- 18 years or older,
- renal colic is suspected upon presentation to the ED suggested by flank pain, back pain, abdominal pain, and/or hematuria, and
- the physician intends to order a CT FPP study for suspicion of a kidney stone. Members of all ethnic and racial groups are eligible.
Exclusion Criteria:
-
Patients will be excluded for any one of the following reasons: patients that are
- pregnant
- prisoners
- unable or unwilling to consent (including non-English speaking) and
- with a history or physical evidence of recent trauma.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01352676
| United States, Connecticut | |
| Shoreline Medical Center | |
| Guilford, Connecticut, United States, 06437 | |
| Yale University, Emergency Department | |
| New Haven, Connecticut, United States, 06519 | |
| Principal Investigator: | Christopher L Moore, MD | Yale University School of Medicine, Emergency Medicine |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT01352676 History of Changes |
| Other Study ID Numbers: | HS018322 |
| Study First Received: | May 10, 2011 |
| Last Updated: | July 8, 2014 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Yale University:
|
renal colic flank pain back pain |
Additional relevant MeSH terms:
|
Colic Renal Colic Abdominal Pain |
Pain Signs and Symptoms Signs and Symptoms, Digestive |
ClinicalTrials.gov processed this record on February 27, 2015