Evaluation of Stone Composition in Surgical Kidney Stone Patients in Vietnam
NCT ID: NCT07038954
Last Updated: 2025-06-26
Study Results
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.
COMPLETED
222 participants
OBSERVATIONAL
2023-07-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Pain Before and After Removal of Non-obstructive Kidney Stones
NCT03657667
Effectiveness of US-Guided PCNL Different Positions in Renal Stones Treatment
NCT05855057
Preoperative Prediction of Flexible Ureteroscopy Outcome in the Treatment of Renal Calculi
NCT05857501
ESWL vs URS in Management of Upper Third Ureteric Calculi
NCT03559738
Ultrasound Imaging of Kidney Stones and Lithotripsy
NCT02214836
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Stone Composition Analysis
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stone Composition Analysis
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 incomplete clinical data.
* Patients with contraindications to surgery.
* Pregnant women
15 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Department of Science and Technology of Ho Chi Minh City
UNKNOWN
Binh Dan Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Binh Dan Hospital
Ho Chi Minh City, Ho Chi Minh, Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22441
Identifier Type: OTHER
Identifier Source: secondary_id
BDH-STONE-2023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.