NCT07038954

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 5, 2025

Last Update Submit

June 24, 2025

Conditions

Keywords

Kidney stone compositionPercutaneous nephrolithotomyStone analysisInfrared spectroscopyCalcium oxalateVietnamBinh Dan HospitalSurgical stone treatmentRecurrent kidney stones

Outcome Measures

Primary Outcomes (1)

  • Proportion of stone types in surgically treated kidney stone patients

    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).

    Within 1 month after surgical stone removal

Study Arms (1)

Surgically Treated Kidney Stone Patients

This cohort includes patients aged 15 years and older who underwent surgical treatment for kidney or ureteral stones at Binh Dan Hospital between July and December 2023. Surgical methods included percutaneous nephrolithotomy (PCNL), semirigid ureteroscopic lithotripsy, laparoscopic ureterolithotomy, and open surgery. Retrieved stone fragments were analyzed using X-ray diffraction (XRD) and infrared spectroscopy (IR) to determine stone composition. No experimental intervention was applied.

Other: Stone Composition Analysis

Interventions

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.

Surgically Treated Kidney Stone Patients

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with kidney stones who underwent surgical treatment at Binh Dan Hospital from July to December 2023 and consented to stone analysis.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binh Dan Hospital

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Kidney stone fragments collected during surgical procedures, including percutaneous nephrolithotomy (PCNL), ureteroscopic lithotripsy, laparoscopic ureterolithotomy, and open stone removal. Samples were retained for compositional analysis using X-ray diffraction (XRD) and infrared spectroscopy (IR). No blood, tissue, or DNA-based samples were collected or retained.

MeSH Terms

Conditions

Kidney CalculiUrolithiasisNephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 26, 2025

Study Start

July 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because this is a single-center observational study with no plan for external data requests. The dataset contains identifiable clinical and imaging information, and there is no established data-sharing protocol for this study.

Locations