An observational study in Ureteric Stone, sponsored by Zayed Military Hospital. Completed at 3 sites in United Arab Emirates. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Zayed Military Hospital · Observational
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.
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.
84 studies on the registry are indexed under Ureterolithiasis; 19 are open to participants now.
This study's enrollment of 92 is below the median of 136 across 13 observational studies indexed under Ureterolithiasis.
Browse Ureterolithiasis studies →Zayed Military Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients presenting to the Emergency Department with symptoms suspicious of urolithiasis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Complicated ureteric colic:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic accuracy comparison
Compare the diagnostic accuracies of the CHOKAI and STONE scores in predicting the presence of ureteric stones by using differences in the area under the curve (AUC) between the CHOKAI and STONE scores, calculated using Receiver Operating Characteristic (ROC) analysis
Time frame: 6 months
Determine optimal cut-off point
Point on ROC analysis where maximum sensitivity and specificity exist. Calculate sensitivity, specificity, positive likelihood ratio and negative likelihood ratio at this point
Time frame: 6 months
Rate of admission for patients
Frequency of admission disposition for patients, to evaluate for any association of high risk on predictor scores to admission dispositions
Time frame: 6 months
Plan to share: Yes — The protocol for selection of patients used for prospective data collection shall be made available for the entirety of the study duration, including the Informed Consent Form we will use during patient encounters. The Statistical Analysis Plan (SAP) will be shared after results are compiled (approximately in 6 months from study start date) and processed by the biostatistician for a period of 3 months
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Protocol and Informed Consent data will be available for 6 months from study start date Study Analysis Plan (SAP) will be available for 3 months once data collection is completed and results compiled for analysis
Access criteria: Any interested researcher can approach the Principal Investigator, Mohammad Anzal Rehman, at chokai.study@outlook.com for any of the details listed above within the time frames mentioned for access to the same.
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Zayed Military Hospital