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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Renal Colic Flank Pain Back Pain |

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 |
- 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.

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 |
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.

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
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 |
Publications:
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 |