Limit Computed Tomography (CT) Scanning in Suspected Renal Colic (Prospective)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01352676
First received: May 10, 2011
Last updated: July 8, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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
Study Population

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.

Criteria

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 Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01352676

Locations
United States, Connecticut
Shoreline Medical Center
Guilford, Connecticut, United States, 06437
Yale University, Emergency Department
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Christopher L Moore, MD Yale University School of Medicine, Emergency Medicine
  More Information

Publications:
Ripolles T, Errando J, Agramunt M, Martinez MJ, Ripolles T, Errando J, Agramunt M, Martinez MJ. Ureteral colic: US versus CT. Abdominal Imaging. Mar-Apr 2004;29(2):263-266

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:
Back Pain
Flank Pain
Renal Colic
Colic
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Abdominal Pain
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on August 20, 2014