NCT01451931

Study of Tomography of Nephrolithiasis Evaluation

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,776 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Urolithiasis

Interventions

Type	Name	Description
OTHER	Point-of-care Ultrasound	Perform ultrasonography in the ED (physician).
RADIATION	Radiology Ultrasound	Diagnostic ultrasound completed in the radiology department at time 0.
OTHER	Radiology CT	Computed tomography of abdomen completed in the radiology department at time 0.

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-10-14
• Last updated: 2014-12-03
• Results posted: 2014-12-03

Locations

15 sites across 1 country: United States