Evaluation of Stone Composition in Surgical Kidney Stone Patients in Vietnam

This is a prospective observational study conducted at Binh Dan Hospital, Ho Chi Minh City, Vietnam, from July to December 2023. The study aims to analyze the composition of kidney stones in patients undergoing surgical interventions such as percutaneous nephrolithotomy (PCNL), ureteroscopic lithotripsy, laparoscopic ureterolithotomy, or open surgery. Stone fragments collected during the procedures were analyzed using X-ray diffraction (XRD) and infrared spectroscopy (IR).

The primary goal of this study is to identify the types and distribution of kidney stone compositions in a Vietnamese surgical cohort and compare them with global patterns. Findings from this study are expected to provide insights into age- and gender-related differences in stone composition, and contribute to improved prevention strategies for recurrent urolithiasis.

The study was approved by the Ethics Committee of the University of Medicine and Pharmacy at Ho Chi Minh City. All participants provided written informed consent.

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Key information

Conditions

Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Binh Dan Hospital

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

About this study

Kidney stone disease (urolithiasis) is a common and recurrent condition worldwide. Vietnam is located in a high-incidence zone known as the "stone belt." Understanding the composition of kidney stones is essential for guiding treatment decisions and implementing effective preventive strategies. Although surgical treatment options have advanced, stone recurrence remains a significant concern. However, there is currently limited data in Vietnam regarding the composition of stones in patients undergoing surgical management.

This prospective observational study is being conducted at the Department of Urology, Binh Dan Hospital, Ho Chi Minh City, Vietnam. The study period is from July to December 2023. Eligible participants include patients aged 15 years and older undergoing surgical stone removal via one of the following procedures: percutaneous nephrolithotomy (PCNL), semirigid ureteroscopic lithotripsy, laparoscopic ureterolithotomy, or open surgery. Patients with missing or unsuitable stone samples, incomplete clinical data, or contraindications to surgery are excluded.

During surgery, retrieved stone fragments are collected for analysis. Stone composition is analyzed using both X-ray diffraction (XRD) and infrared spectroscopy (IR), which are reliable methods for identifying stone components. The analysis focuses on determining the presence of calcium oxalate (monohydrate and dihydrate), phosphate (hydroxyapatite and brushite), uric acid, infection-related stones (struvite and ammonium hydrogen urate), and cystine stones.

This study has received ethical approval from the Ethics Committee of the University of Medicine and Pharmacy at Ho Chi Minh City (Approval No. 22441-DHYD). All participants provide written informed consent prior to enrollment. The study is funded by the Department of Science and Technology of Ho Chi Minh City as part of a provincial-level research initiative, with additional institutional support from Binh Dan Hospital and the University of Medicine and Pharmacy at Ho Chi Minh City.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients aged 15 years and older.
Diagnosed with kidney or ureteral stones requiring surgical intervention.
Underwent PCNL, URS, laparoscopic ureterolithotomy, or open stone surgery.
Provided written informed consent.

Exclusion criteria

Patients with missing or unsuitable stone samples.
Patients with incomplete clinical data.
Patients with contraindications to surgery.
Pregnant women

Treatment and study plan

Stone Composition Analysis

Other

This intervention involves the compositional analysis of kidney stone fragments retrieved during surgical procedures. The stone samples are analyzed using X-ray diffraction (XRD) and infrared spectroscopy (IR) to determine their crystal composition. This is a non-invasive, laboratory-based diagnostic procedure. No drug, device, or therapeutic intervention was administered to participants as part of this observational study.

Primary outcomes

Proportion of stone types in surgically treated kidney stone patients

Time frame: Within 1 month after surgical stone removal

Determination of the proportion of each major stone type (calcium oxalate, phosphate, uric acid, struvite, and cystine) using X-ray diffraction (XRD) and infrared spectroscopy (IR).

Sponsors and collaborators

Lead sponsor

Binh Dan Hospital

Other

Collaborators

Department of Science and Technology of Ho Chi Minh City

Registry information

Official study title

Evaluation of Stone Composition in Patients With Kidney Stones Undergoing Surgical Intervention at Binh Dan Hospita

Acronym: STONE-VN

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jun 26, 2025
Registry last updated: Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed