A Multicenter Prospective Research on the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope
试验速览
- 阶段
- 不适用
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- whether the f-URS could enter the low kidney calyx or not
研究概览
简要总结
This study centers on the treatment of low pole renal stones by flexible ureteroscope and intends to find the key anatomical parameters using a prospective, randomized multi-center trial design and to make a more appropriate standard for flexible ureteroscopy of low pole renal stones.
详细描述
With the development of manufacturing technique, new generation of flexible ureteroscopes have great initiative and passive bending capacity and have greatly expanded its application. In our clinical practice, we have found that IPA (Infundibulopelvic angle) is no longer a decisive factor for the success of f-URS（flexible ureteroscope） surgeries. Thus, we think it is necessary to have further study on the effect of anatomy of renal collecting system for f-URS surgeries.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •• Subject has provided informed consent and indicated a willingness to comply with study treatments
- •Subject is 18-70 yrs of age
- •Subject can be either male or female
- •Subject has a diagnosis of low pole renal stones according to CT urography(CTU) or intravenous pyelogram (IVP) results
- •Subject has a single stone 1~2cm in size (KUB), or multiple stones 1~2cm in cumulative size (KUB), and is a surgical candidate for the ureteroscopic approach
排除标准
- •• Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.)
- •Subject has been diagnosed with a urethral stricture or bladder neck contracture
- •Subject has been diagnosed with a urinary tract infection related to stone obstruction within two weeks
- •Subject has severe hematuria that might blur the vision of the endoscopy
- •Subject is pregnant or in monthly period
- •Subject has coexistent disease like systemic disease, heart disease, lung disfunction or other diseases that could not tolerate the endoscopic surgery or anesthesia.
- •Subject has unadjusted diabetes or high blood pressure
- •Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
- •Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (2 weeks)
- •Subject has been diagnosed with hydronephrosis larger than 3cm according to the B-scan ultrasonography examination
- •Subject has any kind of anatomic abnormality of the urinary system that might have an influence on the surgery
结局指标
主要结局
whether the f-URS could enter the low kidney calyx or not
时间窗: during the operation
Following conditions are regarded as failures: 1. the f-URS couldn't enter the low kidney calyx 2. Though the f-URS has entered the low kidney calyx, it cannot crush the stone.
次要结局
- stone clearance(4 weeks post-operatively)
研究者
Xiaofeng Gao
Changhai Hospital
Changhai Hospital