Comparison of CHOKAI vs STONE Score to Predict the Presence of Ureteric Stones in Patients With Renal Colic: A Multi-center Prospective Observational Study

Completed

• Conditions: Ureteric Stone

• Registration Number: NCT04759417
• Lead Sponsor: Zayed Military Hospital

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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-13
• Study First Posted: 2021-02-18
• Primary Completion: 2022-03-31
• Status Verified: 2024-07
• Study Completion: 2024-07-25
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy comparison	6 months	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

Secondary Outcome Measures

Name	Time	Method
Rate of admission for patients	6 months	Frequency of admission disposition for patients, to evaluate for any association of high risk on predictor scores to admission dispositions
Determine optimal cut-off point	6 months	Point on ROC analysis where maximum sensitivity and specificity exist. Calculate sensitivity, specificity, positive likelihood ratio and negative likelihood ratio at this point

Trial Locations

Locations (3)

Sheikh Shakhbout Medical City; 🇦🇪 Abu Dhabi, United Arab Emirates

Tawam Hospital; 🇦🇪 Abu Dhabi, United Arab Emirates

Zayed Military Hospital; 🇦🇪 Abu Dhabi, United Arab Emirates