Use of POCUS and STONE Criteria Together in the Diagnosis of Nephrolithiasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

490 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients presenting to the emergency department with symptoms suggestive of renal colic will be included in the study at Kocaeli City Hospital's emergency department. Patients with nephrolithiasis considered among the preliminary diagnoses will be enrolled in the study; demographic data, vital signs, and physical examination findings will be recorded on pre-prepared standard data forms.

STONE criteria scores will be calculated by emergency assistants, and bedside ultrasound will be performed for patients. Ultrasonographic findings suggestive of renal colic, such as hydronephrosis, the presence of primary stones, acoustic shadowing of the stone, the presence of twinkle artifact, presence of jet flow, and presence of bladder debris, will be evaluated, and the obtained data will be recorded on the standard data form by the performing assistant physician. In patients where computed tomography, which is the gold standard for detecting stone presence without intervention, is deemed appropriate without any intervention to the primary examining physician, the computed tomography results and ultrasound findings will be compared.

The study aims to evaluate the effectiveness of bedside ultrasound application in diagnosing stone presence in patients, its success in predicting re-admission to the hospital within 1 month, its success in predicting possible alternative diagnoses and complications, in addition to the stone criteria applied in the patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of US-Guided PCNL Different Positions in Renal Stones Treatment

NCT05855057

Percutaneous Nephrolithotomy Renal Stones Ultrasound Therapy; Complications

COMPLETED

Are the Stone Density and Location Useful Parameters for Small Kidney Stones?

NCT03503539

Kidney Calculi Kidney Stone

COMPLETED NA

Ultrasound Imaging of Kidney Stones and Lithotripsy

NCT02214836

Kidney Stones Nephrolithiasis Urolithiasis +1 more

ACTIVE_NOT_RECRUITING NA

Mini-PNCL vs fURS in Management of Nephrolithiasis

NCT04389853

Nephrolithiasis Kidney Stone

COMPLETED NA

Ultrasound First Clinical Decision Support for Suspected Nephrolithiasis

NCT03461536

Nephrolithiasis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Our study is a prospective study that will be conducted in the Emergency Medicine Clinic of Kocaeli City Hospital. Patients aged 18 and above who present to the emergency department of Kocaeli City Hospital with symptoms suggestive of renal colic will be included in the study if they volunteer. After examination by a resident physician working in the emergency department, patients for whom nephrolithiasis is considered among the preliminary diagnoses will be notified to the principal investigators. After obtaining written consent, demographic data, vital signs, and physical examination findings will be recorded on previously prepared standard data forms.

Patients scoring 8 points or higher according to the STONE criteria based on history, physical examination, and laboratory results will undergo bedside ultrasound. The ultrasound will be performed by 4 resident physicians with a basic ultrasound course certificate from the Turkish Emergency Medicine Association, who have 2 years of experience. The bedside urinary ultrasound will be performed using the 'Esaote Mylab Gamma® device (Genoa, Italy)' ultrasound machine with the 'Esaote AC2541 curved array (1-8 MHz) probe (Genoa, Italy)' while the patient is in the supine position.

During renal ultrasound, the convex ultrasound probe will be placed in the right upper quadrant of the patient, intersecting the right lower intercostal area and the mid-axillary line. In the left upper quadrant, the probe will be placed in the lower intercostal area along the posterior axillary line. The ultrasound probe will be positioned longitudinally with the indicator pointing towards the patient's head. Subsequently, the same area will be imaged transversely with the indicator pointing towards the patient's right.

In these sections, images of the kidneys will be evaluated for the presence of hydronephrosis, the degree of expansion of pelvic-calyceal structures, stone size, kidney dimensions, parenchymal echogenicity, and the presence of primary stones or acoustic shadowing from stones. Then, from the suprapubic region, the probe will be positioned transversely and longitudinally, sequentially showing the patient's right and head; the presence of globules in the bladder, bladder dimensions, the presence of stones, and the degree of jet flow at the junction of the ureters with the bladder will be assessed using color frequency mode (CFM). The presence of twinkling artifacts with color frequency mode (CFM) will be evaluated when a stone is suspected. The data obtained will be recorded on the study form by the resident physician performing the ultrasound. The recorded data will later be compared with the gold standard diagnostic method, computed tomography routinely performed in patients with nephrolithiasis, for effectiveness.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Colic Stone, Kidney Hydronephrosis Nephrolithiasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Renal Ultrasonography

To investigate the primary and secondary signs of stones with ultrasound and to additionally use the Stone criteria in patients with suspected nephrolithiasis.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

STONE criteria

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- All volunteer patients

Exclusion Criteria

* Pregnant patients,
* Patients for whom the clinician does not give an indication for computed tomography,
* Patients with a previous history of nephrectomy and kidney transplantation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No