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

NCT07126847 | Active Not Recruiting DMC

• 1 other identifier: 2023-10
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Colic; Stone, Kidney; Hydronephrosis; Nephrolithiasis

Keywords

POCUS; STONE; Renal Colic; Nephrolithiasis

Outcome Measures

Primary Outcomes (1)

• Nephrolithiasis diagnostic accuracy

  Adding bedside focused ultrasonography to the STONE criteria increases diagnostic accuracy in patients presenting to the emergency department with a preliminary diagnosis of nephrolithiasis.

  2 year

Secondary Outcomes (2)

• Predicting the possible complications

  2 year

• Readmission to hospital.

  1 month

Interventions

Renal Ultrasonography DIAGNOSTIC_TEST

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

Also known as: STONE criteria

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

Volunteer patients over the age of 18 who applied to the emergency department of Kocaeli City Hospital with renal colic will be included in the study.

You may qualify if:

• \- All volunteer patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, İzmit, 41060, Turkey (Türkiye)

Location

Related Publications (8)

• Rosen's Emergency Medicine: Concepts and Clinical Practice 10th Edition-June 13, 2022 Authors: Ron Walls, Robert Hockberger, Marianne Gausche-Hill, Timothy B. Erickson, Susan R. Wilcox

  BACKGROUND

• Teichman JM, Long RD, Hulbert JC. Long-term renal fate and prognosis after staghorn calculus management. J Urol. 1995 May;153(5):1403-7.

  PMID: 7714951 BACKGROUND

• Preminger GM, Tiselius HG, Assimos DG, Alken P, Buck C, Gallucci M, Knoll T, Lingeman JE, Nakada SY, Pearle MS, Sarica K, Turk C, Wolf JS Jr; EAU/AUA Nephrolithiasis Guideline Panel. 2007 guideline for the management of ureteral calculi. J Urol. 2007 Dec;178(6):2418-34. doi: 10.1016/j.juro.2007.09.107. No abstract available.

  PMID: 17993340 BACKGROUND

• Westphalen AC, Hsia RY, Maselli JH, Wang R, Gonzales R. Radiological imaging of patients with suspected urinary tract stones: national trends, diagnoses, and predictors. Acad Emerg Med. 2011 Jul;18(7):699-707. doi: 10.1111/j.1553-2712.2011.01103.x.

  PMID: 21762233 BACKGROUND

• Berrington de Gonzalez A, Mahesh M, Kim KP, Bhargavan M, Lewis R, Mettler F, Land C. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009 Dec 14;169(22):2071-7. doi: 10.1001/archinternmed.2009.440.

  PMID: 20008689 BACKGROUND

• Moore CL, Carpenter CR, Heilbrun ML, Klauer K, Krambeck AC, Moreno C, Remer EM, Scales C, Shaw MM, Sternberg KM. Imaging in Suspected Renal Colic: Systematic Review of the Literature and Multispecialty Consensus. J Urol. 2019 Sep;202(3):475-483. doi: 10.1097/JU.0000000000000342. Epub 2019 Aug 8.

  PMID: 31412438 BACKGROUND

• Smith-Bindman R, Aubin C, Bailitz J, Bengiamin RN, Camargo CA Jr, Corbo J, Dean AJ, Goldstein RB, Griffey RT, Jay GD, Kang TL, Kriesel DR, Ma OJ, Mallin M, Manson W, Melnikow J, Miglioretti DL, Miller SK, Mills LD, Miner JR, Moghadassi M, Noble VE, Press GM, Stoller ML, Valencia VE, Wang J, Wang RC, Cummings SR. Ultrasonography versus computed tomography for suspected nephrolithiasis. N Engl J Med. 2014 Sep 18;371(12):1100-10. doi: 10.1056/NEJMoa1404446.

  PMID: 25229916 BACKGROUND

• Moore CL, Bomann S, Daniels B, Luty S, Molinaro A, Singh D, Gross CP. Derivation and validation of a clinical prediction rule for uncomplicated ureteral stone--the STONE score: retrospective and prospective observational cohort studies. BMJ. 2014 Mar 26;348:g2191. doi: 10.1136/bmj.g2191.

  PMID: 24671981 BACKGROUND

MeSH Terms

Conditions

Renal Colic; Kidney Calculi; Hydronephrosis; Nephrolithiasis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical

Study Officials

• Asım Enes Özbek

  Kocaeli City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: August 17, 2025
• Study Start: February 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

TU (1)