Comparison of Efficacy and Safety of Extracorporeal Shockwave Lithotripsy: A Randomized, Controlled Trial Study of Electroconductive and Electrohydraulic Types
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- creatinine
研究概览
简要总结
To evaluate the efficacy and safety of electroconductive (EC) and electrohydraulic (EH) extracorporeal shock wave lithotripsy (ESWL) for the treatment of ureter and kidney stones, this study conducted a randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The analysis included cases of stones in the upper kidney and ureter, with diameters ranging from 5 mm to 15 mm.
排除标准
- •Patients with musculoskeletal deformities, ongoing urinary tract infections requiring prioritized infection treatment, blood clotting disorders, and ureteral obstruction that made stone expulsion difficult were excluded from the study.
研究组 & 干预措施
Electroconductive Type
Sonolith i-move® shockwave lithotripter (EDAP, Lyon, France)
干预措施: Electroconductive and Electrohydraulic types (Device)
Electrohydraulic Type
Rifle lithotripter (HNT Medical, Seoul, Korea)
干预措施: Electroconductive and Electrohydraulic types (Device)
结局指标
主要结局
creatinine
时间窗: 2 weeks
patient's records
age
时间窗: 2 weeks
patient's records
Used power
时间窗: 2 weeks
ESWL
Gender
时间窗: 2 weeks
patient's records
drinking
时间窗: 2 weeks
patient's records
height
时间窗: 2 weeks
meters
Diabetes mellitus
时间窗: 2 weeks
patient's records
Preoperative Double J stent
时间窗: 2 weeks
patient's records
Speed
时间窗: 2 weeks
ESWL
weight
时间窗: 2 weeks
kilograms
smoking
时间窗: 2 weeks
patient's records
Hypertension
时间窗: 2 weeks
patient's records
Glomerular Filtration Rate
时间窗: 2 weeks
patient's records
hemoglobin
时间窗: 2 weeks
patient's records
Hounsfield unit
时间窗: 2 weeks
patient's records
Urine Turbidity
时间窗: 2 weeks
patient's records
Satisfaction score
时间窗: 2 weeks
1. Not satisfied at all. 2. Very low satisfaction. 3. Moderate satisfaction. 4. High satisfaction. 5. Very high or maximum satisfaction.
stone size
时间窗: 2 weeks
patient's records
Stone volume
时间窗: 2 weeks
patient's records
Stone to skin distance
时间窗: 2 weeks
patient's records
Urine pH
时间窗: 2 weeks
patient's records
Intensity
时间窗: 2 weeks
ESWL
Analgesic
时间窗: 2 weeks
patient's records
Stone laterality
时间窗: 2 weeks
patient's records
Stone location
时间窗: 2 weeks
patient's records
Urine color
时间窗: 2 weeks
patient's records
Shock
时间窗: 2 weeks
ESWL
Hydronephrosis grade
时间窗: 2 weeks
* Grade 0 : Normal examination with no dilation of the renal pelvis * Grade 1 : Mild dilation of the renal pelvis only * Grade II : Moderate dilation of the renal pelvis including a few calyces * Grade III : Dilation of the renal pelvis with visualization of all the calyces, which are uniformly dilated, and normal renal parenchyma * Grade IV : Similar apperance of the renal pelvis and calyces as Grade III, plus thinning of the renal parenchyma
Stone shape
时间窗: 2 weeks
patient's records
Urine Specific Gravity
时间窗: 2 weeks
patient's records
Stone-free rates (%)
时间窗: 2 weeks
ESWL
Visual analog scale for pain
时间窗: 2 weeks
0: Represents "No sensation" or "Not at all." 1-3: Indicates a very mild sensation or a low level of the experience, signifying almost no problem. 4-6: Represents a moderate level, suggesting a moderate presence of the experience or issue. 7-9: Reflects a high or severe level, signifying a significant presence or seriousness of the problem. 10: Represents "Maximal sensation" or "Extremely intense" and indicates an extreme presence or severity of the experience or issue.
次要结局
未报告次要终点
研究者
Sung Yong Cho
Clinical Professor
Seoul National University Hospital