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

NCT04759417 | Completed

• 1 other identifier: SEHA-019
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 3

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.

Conditions

Ureteric Stone

Keywords

ureteric stone; CHOKAI; STONE; UAE; renal colic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determine optimal cut-off point

  6 months

• Rate of admission for patients

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting to the Emergency Department with symptoms suspicious of urolithiasis

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zayed Military Hospital: lead

Study Sites (3)

Sheikh Shakhbout Medical City

Abu Dhabi, United Arab Emirates

Location

Tawam Hospital

Abu Dhabi, United Arab Emirates

Location

Zayed Military Hospital

Abu Dhabi, United Arab Emirates

Location

MeSH Terms

Conditions

Ureterolithiasis; Renal Colic

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad Anzal Rehman, MD

  Zayed Military Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Resident

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 18, 2021
• Study Start: February 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: July 25, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

AE (3)