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

Ureteric Stone Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04759417
• Other study ID #: SEHA-019
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: February 2022
• Source: Zayed Military Hospital
• Contact: Mohammad Anzal Rehman, MD
• Phone: +971526800390
• Email: anzalrehman[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Calculi
• Renal Colic
• Ureteral Calculi
• Ureteric Stone
• Ureterolithiasis

Locations

Country	Name	City	State
United Arab Emirates	Sheikh Shakhbout Medical City	Abu Dhabi
United Arab Emirates	Tawam Hospital	Abu Dhabi
United Arab Emirates	Zayed Military Hospital	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Zayed Military Hospital

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	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	6 months
Secondary	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	6 months