Clinical trial NCT04759417: Comparison of CHOKAI vs STONE Score to Predict the Presence of Ureteric Stones in Patients With Renal Colic: A Multi-center Prospective Observational Study
Official title: A Multi-center Prospective Observational Study to Evaluate and Compare Diagnostic Accuracy and Reliability of Variables of the CHOKAI and STONE Scores to Predict the Presence of Ureteric Stones as Confirmed on CT Scans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ureteric Stone
Keywords: ureteric stone
CHOKAI
STONE
UAE
renal colic
Lead sponsor: Zayed Military Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-18
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting to the Emergency Department with symptoms suspicious of urolithiasis

Brief summary: Background: The STONE score has traditionally been used as a clinical prediction tool to predict the presence of ureteric stones in patients presenting with renal colic. More recently, the CHOKAI score was introduced and found to have superior diagnostic accuracy on both internal and external validation.

Objective: Our study aims to externally validate and compare the use of both the CHOKAI and STONE score in a population of UAE patients presenting to the Emergency Department for renal colic.

Methods: Over a period of approximately 6 months, the study will follow Emergency Department Physicians at each institution and retrieve data from their encounters with patients presenting with renal colic. Parameters for both CHOKAI and STONE scores will be logged, extracted and matched against a reference standard of CT scan to compare diagnostic accuracy of both scores to predict the presence of ureteric stones in this population.

Goals: Evaluation of the findings will discern applicability of scores to the UAE population and contribute to reducing unnecessary radiation exposure.

To our knowledge, no studies have compared the use of these scores to diagnose urolithiasis in the United Arab Emirates. Furthermore, this will be the first study to externally validate the CHOKAI score outside of Japan using a controlled, prospective design.

Detailed description: Over a period of approximately 6 months, the study will follow Emergency Department Physicians at each of three separate institutions and retrieve data from their encounters with patients presenting with renal colic. Parameters for both CHOKAI and STONE scores will be logged, extracted and matched against a reference standard of CT scan to compare diagnostic accuracy of both scores to predict the presence of ureteric stones in this population

Full-time ED Physicians from each institution will be recruited to participate in the study as follows:

Each ED Physician shall be provided with Data Collection Sheet. This form will provide them with a standardized option to enter the components of the STONE and CHOKAI score using data normally conducted in the history taking and physical examination of patients suspected to have ureteric stones. Additional items have also been included to investigate for other variables that could influence clinical prediction of presence of ureteric stones.

Those patients suspected to have ureteric stones will have confirmation of urolithiasis by non-contrast CT scan. Though the investigators will log the data in their respective data collection sheets per patient, they will not be involved in entering this data onto the study's database.

Data will be collected for a period of approximately 6 months from February 1, 2021 onward, with a target sample size of 200 patients.

Eligibility criteria: Inclusion Criteria:

* Adult population (≥18 years of age) presenting to the Emergency Department with symptoms determined by the investigating ED Physician to be suspicious of urolithiasis (e.g. flank pain, lower abdominal pain, back pain and/or hematuria)
* Patients suspected to have ureteric stone who underwent CT scan to confirm diagnosis

Exclusion Criteria:

Complicated ureteric colic:

* Abnormal vital signs - body temperature \> 37.7 °C or systolic blood pressure ˂90 mmHg)
* Active malignancy
* Abnormal kidney function (abnormal levels of creatinine/BUN)
* Recent (within past 6 months) trauma or urologic surgery
* Age \<18 years
* Pregnant patient
* Patient with incomplete interview/documentation data (e.g. missing US/CT/ UA)

Primary outcomes:
measure: Diagnostic accuracy comparison
timeFrame: 6 months
Secondary outcomes:
measure: Determine optimal cut-off point
timeFrame: 6 months
measure: Rate of admission for patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Shakhbout Medical City
city: Abu Dhabi
country: United Arab Emirates
facility: Tawam Hospital
city: Abu Dhabi
country: United Arab Emirates
facility: Zayed Military Hospital
Study officials:
affiliation: Zayed Military Hospital
name: Mohammad Anzal Rehman, MD
role: PRINCIPAL_INVESTIGATOR
References: