跳至主要内容
临床试验/NCT03919227
NCT03919227Unknown不适用

Measurement of Resistance During UAS Insertion Procedure in RIRS: the Effects of Bladder Filling Degree and the Assessment of Ureter Injury.

Guohua Zeng1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年9月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
UAS insertion success rate

研究概览

简要总结

Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, but can be accompanied by serious complications. In long-term clinical practice, the investigators has found that different Bladder Filling Degree was accompanied by different Resistance During UAS Insertion Procedure in RIRS, which leads to the difference in success rate of UAS insertion.The investigator aims to perform a prospective and randomized controlled trial comparing the success rate of UAS insertion procedure under different bladder filling degree,and discuss the relationship between insertion resistance and ureter injury.

详细描述

Upper urinary calculi is a common disease that endangers human health, Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, for UAS can drain irrigation to reduce renal pelvic pressure and maintain vision clear. But incorrect way to insert UAS can be accompanied by serious complications. For instance, If the ureter was not dilated by DJ stent before RIRS surgery, or ureter was relatively narrow, the insertion of UAS would encounter great resistance. Sometimes the ureter was violently pushed into UAS, it might cause ureteral perforation or avulsion. As for how to insert UAS correctly, there is no unified international standard at present. Different surgeons have different experience. In long-term clinical practice, the investigators has found that different Bladder Filling Degree was accompanied by different Resistance During UAS Insertion Procedure in RIRS, which leads to the difference in success rate of UAS insertion. In addition, there seems to be some relationship between the resistance of UAS insertion and the ureter injury in surgery. Therefore, the investigator aims to perform a prospective and randomized controlled trial comparing the success rate of UAS insertion procedure under different bladder filling degree, and discuss the relationship between insertion resistance and ureter injury.

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
None

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

入选标准

  • Patients must be a suitable operative candidate for RIRS
  • Age 18 to 70 years
  • Normal renal function 4 .ASA score Ⅰ and Ⅱ
  • Single renal or ureteral stone ≤20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm

排除标准

  • Uncorrected coagulopathy and active urinary tract infection (UTI)
  • Severe cardiopulmonary dysfunction, can not tolerate sugery
  • Patients who underwent transplant or urinary diversion
  • Definite diagnosis of ureteral stricture or a history of stricture
  • The bladder volume is less than 100ml

研究组 & 干预措施

Group 1: empty bladder

Experimental

In group 1, investigator empty the bladder of urine with a catheter before inserting UAS.

干预措施: empty bladder before inserting UAS (Procedure)

Group 2: natural state of bladder

Active Comparator

In group 2, investigator does not interfere with the filling degree of bladder before inserting UAS.

干预措施: do not interfere with the filling degree of bladder (Procedure)

结局指标

主要结局

UAS insertion success rate

时间窗: intraoperatively

Primary insertion of a UAS is not always successful. The ideal position of the UAS is with its distal extremity just below the ureteric-pelvic junction (UPJ). Insertion failure is defined as UAS cross the upj or do not reach the proximal ureter or the surgeon's decision to resign UAS insertion due to high resistance to the retrograde progression of the UAS along the urinary tract.

次要结局

  • resistance of UAS insertion(intraoperatively)
  • Ureteral lesion grade(intraoperatively)
  • Complication rate(1 month after removing the pigtail stent)

研究者

发起方
Guohua Zeng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Guohua Zeng

Vice president

The First Affiliated Hospital of Guangzhou Medical University

研究点 (1)

Loading locations...

相似试验