Study of Tomography of Nephrolithiasis Evaluation

Phase 4CompletedNCT01451931

University of California, San Francisco2,776 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Conditions

Urolithiasis

Interventions

Point-of-care UltrasoundOTHER

Perform ultrasonography in the ED (physician).

Radiology UltrasoundRADIATION

Diagnostic ultrasound completed in the radiology department at time 0.

Radiology CTOTHER

Computed tomography of abdomen completed in the radiology department at time 0.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (15)

UCSF at Fresno

Fresno, California, United States

University of California, Davis

Sacramento, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 30 days from baseline

Cumulative Radiation Exposure

Time frame: Baseline plus 6 months post-baseline

Secondary Outcomes

ED Length of Stay

Time frame: Baseline visit excluding hospitalization

Return Visits to ED or Hospital

Time frame: 6 months post-baseline

Accuracy for Stones by Arm

Time frame: Up to 6 month follow-up for stone passage

Data from ClinicalTrials.gov

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