Evaluation of Stone Composition in Patients With Kidney Stones Undergoing Surgical Intervention at Binh Dan Hospita
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Proportion of stone types in surgically treated kidney stone patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with missing or unsuitable stone samples.
- •Patients with incomplete clinical data.
- •Patients with contraindications to surgery.
- •Pregnant women
结局指标
主要结局
Proportion of stone types in surgically treated kidney stone patients
时间窗: 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).
次要结局
未报告次要终点