Phase 4
Completed N=2,776
Study of Tomography of Nephrolithiasis Evaluation
Source: ClinicalTrials.gov NCT01451931 ↗Enrolled (actual)
2,776
Serious AEs
0.4%
Results posted
Dec 2014
Primary outcomePrimary: High Risk Diagnosis With Complication — 6; 3; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY High Risk Diagnosis With Complication |
6; 3; 2 | — |
| PRIMARY Cumulative Radiation Exposure |
10.1; 9.3; 17.2 | — |
| SECONDARY ED Length of Stay |
5.1; 6.4; 6.3 | — |
| SECONDARY Return Visits to ED or Hospital |
231; 231; 255; 87; 84; 83 | — |
| SECONDARY Accuracy for Stones by Arm |
85; 84; 86; 50; 53; 53 | — |
Eligibility Criteria
Inclusion Criteria
- men or women = or >18 but 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)
Data sourced from ClinicalTrials.gov (NCT01451931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.