ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01352676
Recruitment Status : Completed
First Posted : May 12, 2011
Last Update Posted : July 9, 2014
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Yale University

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
Renal Colic Flank Pain Back Pain

  Show Detailed Description

Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 635 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Decision Rule to Limit CT Scanning in Suspected Renal Colic
Study Start Date : May 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Ultra Low Dose vs Regular CT Scans [ Time Frame: Baseline-90 Days ]
    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.


Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Christopher L Moore, MD Yale University School of Medicine, Emergency Medicine
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
Medicare Part B Imaging Services. General Accounting Office. Washington D.C., 2008.
Baumgarten DA, Francis IR, Bluth EI, Bush WH, Imaging EPoU. ACR Appropriateness Criteria® acute onset flank pain, suspicion of stone disease. American College of Radiology; 2007

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
First Posted: May 12, 2011    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014

Keywords provided by Yale University:
renal colic
flank pain
back pain

Additional relevant MeSH terms:
Back Pain
Colic
Renal Colic
Flank Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Infant, Newborn, Diseases