The
main objectives behind this study are:
(i) To develop a structured data collection tool for evaluation of patients with acute flank pain.
(ii) To conduct a two
years prospective study on ED patients presenting with acute flank pain
suggestive of renal colic.
(iii) To assess the
inter-observer reliability of the clinical findings.
(iv) To develop an accurate, reliable and sensitive clinical decision rule that guides the use of CT for patients with acute flank pain.
The outcomes that will
be measured in this study, and more specifically during the follow-up
assessment survey, are divided into primary and secondary. The primary
outcome is a composite parameter based on the development of a serious
result within two weeks of presentation of any of the following: death, acute
renal injury, sepsis, need for acute urologic intervention
and need for acute non-urologic surgical intervention. Death will be
confirmed through the findings in the medical record. Acute renal injury will
be defined according to the RIFLE criteria as a twofold increase in the serum
creatinine, or GFR decrease by 50 percent, or urine output <0.5 mL/kg per
hour for 12 hours (Bellomo et al, 2004). Sepsis will be defined in accordance
with the 2001 International Sepsis Definitions Conference, as the presence of
the systemic inflammatory response syndrome with an existing infection (Levy et
al, 2003). The need for acute urologic or non-urologic intervention will be considered
if the intervention was related to the initial complaint and failure to
intervene would cause the patient a serious outcome. Admission for intravenous
fluids or pain/nausea control will not be considered as a serious outcome.
The secondary
outcome will include hospitalization or representation to the ED
for intravenous fluids or pain/nausea control for a condition related to
the initial presentation.
The targeted population
for the prospective study will include all patients above the age of 18
presenting to the AUBMC ED with complaints suggestive of urolithiasis or nephrolithiasis
during a period of two years from November 1, 2011 until October 31, 2013. Eligibility
for the study will be determined by the attending physician after assessing the
patient on arrival to the ED. If the following characteristics are both met,
the patient will be included in the study.