Study of Tomography of Nephrolithiasis Evaluation

Study Overview
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Brief Summary
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This is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared to computed tomography (CT) for the initial emergency room evaluation of patients with suspected renal colic. The investigators will compare several measures of effectiveness including morbidity related to the patient's underlying disease, or complications related to delayed diagnosis, patient status regarding pain/missed days of work, and utilization of health care resources based on one of three study arms: ultrasound in the Emergency Department, ultrasound in Radiology or CT.

Detailed Description
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This is a multi-center, randomized controlled trial of ultrasonography compared with computed tomography (CT) for the evaluation of patients with suspected urolithiasis. The study will be conducted at 15 large urban Emergency Departments (EDs), reflecting geographic, socioeconomic, racial and ethnic diversity, and include academic medical centers as well as safety net hospitals. The patients will be randomized to one of three arms: 1) ultrasound in the Emergency Department (ED), 2) ultrasound in radiology or 3) CT in radiology. The investigators will then collect precise and unbiased data on a comprehensive range of outcomes that will allow assessment of effectiveness, safety, accuracy and cost between patients randomized to one the three groups. Taken together, these measures are intended to provide the basis for a valid comparison of imaging of patients with suspected urolithiasis seen in the ED. The results of this trial could lead to a change in clinical practice that is associated with both improved patient outcomes and reduced cost. Broad stakeholder involvement from within radiology, emergency medicine and several subspecialty communities has been sought to ensure the strategic completion of study aims and to help rapidly disseminate the results of the study into clinical practice. This will create a collaborative network of EDs willing to act as a laboratory for studying the comparative effectiveness of diagnostic testing. As a result, the proposed trial will demonstrate the feasibility of conducting Randomized Control Trials (RCTs) of imaging that incorporates measurements of outcomes that can be expanded to additional imaging tests in the future.

Official Title
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Randomized Controlled Trial of Ultrasound Versus CT (Computed Tomography) for Patients in the Emergency Department With Suspected Renal Colic

Conditions
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Urolithiasis

Intervention / Treatment
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* Other: Point-of-care Ultrasound
* Radiation: Radiology Ultrasound
* Other: Radiology CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men or women = or >18 but <76 years of age presenting with acute renal colic Emergency department physician highly suspects a primary diagnosis of kidney stones (renal colic) or the patient requires imaging to rule out kidney stones. Exclusion Criteria: children < 18 years old elderly patients > or = 76 years old pregnancy or planning pregnancy Morbid obesity (>285 pounds in men, >250 pounds in women) patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected). history of kidney problems (hemodialysis, kidney transplant, presence of only one kidney)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Point-of-care Ultrasound<br>Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department. Perform ultrasonography in the ED (physician). | Other: Point-of-care Ultrasound<br>* Perform ultrasonography in the ED (physician).<br>|
| Experimental: Radiology Ultrasound<br>Patient with suspected urolithiasis will receive diagnostic ultrasonography in the radiology department. Diagnostic ultrasound completed in the radiology department at time 0. | Radiation: Radiology Ultrasound<br>* Diagnostic ultrasound completed in the radiology department at time 0.<br>|
| Experimental: Radiology CT<br>Patient with suspected urolithiasis will receive computed tomography in the radiology department. Computed tomography of abdomen completed in the radiology department at time 0. | Other: Radiology CT<br>* Computed tomography of abdomen completed in the radiology department at time 0.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Risk Diagnosis With Complication | Missed or delayed diagnosis of appendicitis, pneumonia with sepsis, diverticulitis, abdominal aortic aneurysm with rupture, mesenteric ischemia with bowel perforation, renal infarction, stone with renal abscess, urosepsis/pyelonephritis with bacteremia, ovarian torsion with necrosis related to randomization and due to imaging modality. | 30 days from baseline | 
| Cumulative Radiation Exposure |  | Baseline plus 6 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ED Length of Stay |  | Baseline visit excluding hospitalization | 
| Return Visits to ED or Hospital |  | 6 months post-baseline | 
| Accuracy for Stones by Arm |  | Up to 6 month follow-up for stone passage | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney stone, urolithiasis, urinary tract infection, ultrasound, computed tomography, safety, cost, accuracy