Comparison of the Efficacy of Flexible Ureteroscope and Percutaneous Nephroscopic Surgery in the Treatment of 2-4cm Kidney Stones: a Multicenter Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Stone free-rate (SFR)
研究概览
简要总结
Urolithiasis is a common disease in urology. With the continuous progress of science and technology, the treatment of kidney lithiasis has undergone revolutionary changes, and the previously commonly used open surgical lithotomy method has been gradually eliminated, and replaced with less traumatic treatment methods. Percutaneous nephroscopy can theoretically treat the vast majority of kidney stones, especially in the treatment of kidney stones > 2 cm, it is widely used. With the development of ureteroscopy technology, the adaptation of ureteroscopy for the treatment of kidney stones has been expanding, and people have gradually paid attention to it with less damage and higher safety. This study aims to evaluate whether the efficacy and safety of soft ureteral lithotomy in the treatment of 2-4cm kidney stones is equal to that of percutaneous nephrolithotomy through prospective randomized controlled clinical trials, so as to provide more choices for physicians and patients, and provide theoretical basis for the standardization of clinical practice and the rationality of treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient agrees to participate in the experiment and signs the informed consent, including compliance with the requirements of the experiment
- •American Society of Anesthesiologists (ASA) score of 1-2, tolerate surgery
- •Age 18-70 years old
- •Diagnosed with renal stones via CT scan, with the largest diameter of the stone being 2-4 cm.
排除标准
- •Excessive obesity, BMI > 28
- •Severe urinary tract infection not corrected
- •Previous history of kidney transplantation or urinary tract diversion surgery
- •Uncorrected bleeding or patients with coagulation dysfunction
- •Urinary system congenital malformations, such as polycystic kidney, horseshoe kidney, pelvic ectopic kidney, etc
- •Combined with serious heart and lung dysfunction and failure of important organs and cannot tolerate anesthesia or surgery
研究组 & 干预措施
flexible ureteroscopic lithotripsy
干预措施: flexible ureteroscopic lithotripsy (Procedure)
percutaneous nephrolithotomy
干预措施: percutaneous nephrolithotomy (Procedure)
结局指标
主要结局
Stone free-rate (SFR)
时间窗: All patients underwent a 2mm plain CT scan 1 month after surgery to assess final SFR.
Stone-free status is defined as the absence of any residual stone fragments or the presence of clinically meaningless residual stone fragments in the kidney, defined as ≤4mm, asymptomatic, non-obstructive, and non-infectious stone particles.
次要结局
- Time of operation(From transurethral surgery to indwelling fistula or catheter, assessed up to 6 hours.)
- Length of stay(From leaving the operating room to discharge,assessed up to 1 month.)
- Postoperative complication(Any surgery-related adverse events that occurred during or less than one month after surgery.)
- Hospitalization costs(From admission to discharge,assessed up to 1 month.)
研究者
Yanbo Wang
Clinical Professor
The First Hospital of Jilin University