Kidney StonesSTONE-VNNCT07038954
Evaluation of Stone Composition in Surgical Kidney Stone Patients in Vietnam
An observational study of Kidney Stones and Urolithiasis, run by Binh Dan Hospital at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Kidney Stones, Urolithiasis, Nephrolithiasis
- What is being tested?
- Stone Composition Analysis
- How many people
- 222 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jul 2023to 31 Dec 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with kidney stones who underwent surgical treatment at Binh Dan Hospital from July to December 2023 and consented to stone analysis.
Who may be able to join
- 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.
Who cannot join
- Patients with missing or unsuitable stone samples.
- Patients with incomplete clinical data.
- Patients with contraindications to surgery.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Stone Composition in Patients With Kidney Stones Undergoing Surgical Intervention at Binh Dan Hospita
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.
Read the detailed description
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.
- Conditions
- Kidney Stones, Urolithiasis, Nephrolithiasis
- Being tested
- Stone Composition Analysis
- Keywords
- Kidney stone composition, Percutaneous nephrolithotomy, Stone analysis, Infrared spectroscopy, Calcium oxalate, Vietnam, Binh Dan Hospital, Surgical stone treatment, Recurrent kidney stones
- Medical subject headings
- Kidney Calculi, Urolithiasis, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stone Composition AnalysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Stone Composition Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 1 month after surgical stone removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jul 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Binh Dan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Science and Technology of Ho Chi Minh City
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038954
- Sponsor's protocol ID
- BDH-STONE-2023
- Other IDs
- 22441
- Acronym
- STONE-VN
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Stone Composition in Patients With Kidney Stones Undergoing Surgical Intervention at Binh Dan Hospita
- ClinicalTrials.gov ID
- NCT07038954
- Acronym / sponsor ID
- STONE-VN / BDH-STONE-2023
- Conditions
- Kidney Stones, Urolithiasis, Nephrolithiasis
- Keywords
- Kidney stone composition, Percutaneous nephrolithotomy, Stone analysis, Infrared spectroscopy, Calcium oxalate, Vietnam, Binh Dan Hospital, Surgical stone treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Binh Dan HospitalUniversity, hospital or other
- Collaborators
- Department of Science and Technology of Ho Chi Minh City
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgically Treated Kidney Stone Patients | – | Other: Stone Composition AnalysisThis 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. |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with kidney stones who underwent surgical treatment at Binh Dan Hospital from July to December 2023 and consented to stone analysis.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients with missing or unsuitable stone samples.
- Patients with incomplete clinical data.
- Patients with contraindications to surgery.
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stone Composition AnalysisThis 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. | Other | Surgically Treated Kidney Stone Patients |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stones and Urolithiasis, run by Binh Dan Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of stone types in surgically treated kidney stone patients (time frame: Within 1 month after surgical stone removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.