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临床试验/NCT06122129
NCT06122129已完成不适用

Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones: a Randomized Controlled Trial.

New Valley University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年11月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
Operative time

研究概览

简要总结

The aim of this study is to evaluate the flexible ureteroscope (FURS) technique with and without ureteral access sheath (UAS).

详细描述

Treating a large renal stone, more than 2 cm, is changing during the last decades. Technological innovations have led to a significant improvement in flexible ureteroscopes over recent years.

Many authors have used flexible ureteroscope (FURS) with laser fragmentation as proved treating modality with high efficacy. Although percutaneous extraction of large renal stones is still the first option, it has higher and more severer complications than flexible ureteroscopy.

FURS has developed into a standard diagnostic and treatment modality for upper urinary stone disease, transitional cell carcinoma and ureteral strictures. Indeed, more recently FURS is becoming a minimally invasive competitor to percutaneous nephrolithotomy for larger kidney stones as well as an accepted modality for localized treatment of small upper urinary tract transitional cell carcinoma.

The use of ureteral access sheath (UAS) is widely recognized as a technique utilized to keep the intrarenal pressure low when performing FURS for larger and more complex stones, although some authors advocate its use for most renal stones. UASs are now produced with varying characteristics including various lengths, diameters, materials, dilator tip designs, radiopaque markers, and stiffness. However, it also rises surgical costs and may injure the ureteral wall.

Most common reasons cited by urologists for using a UAS are to facilitate repeated entrance into the ureter and collecting system (as a time-saver), lower intrarenal pressure and protection of ureteroscope and ureter when extracting stone fragments. UAS has encouraged urologists in the fragmentation of large stones; it facilitates multiple entries and stone extraction during FURS.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years old.
  • Both sexes.
  • Patients with upper ureter and renal stones scheduled for flexible ureteroscope.

排除标准

  • Patients with associated distal ureteral stone, kidney transplant or any kind of urinary diversion.
  • Larger stones (11 cm) where the routine use of an access sheath will be felt appropriate to aid multiple passes of the scope.
  • Known ureteric strictures.
  • Concomitant ureteric stones.
  • Patients with narrow ureter where ureteral access sheath was anticipated to be difficult.

研究组 & 干预措施

Flexible ureteroscope with ureteral access sheath

Experimental

Stones will be treated by flexible ureteroscope with ureteral access sheath

干预措施: Flexible ureteroscope with ureteral access sheath (Procedure)

Flexible ureteroscope without ureteral access sheath

Active Comparator

Stones will be treated by flexible ureteroscope without ureteral access sheath

干预措施: Flexible ureteroscope without ureteral access sheath (Procedure)

结局指标

主要结局

Operative time

时间窗: Intraperatively

Time from sterilization till the end of surgery

次要结局

  • Number of patients who need ancillary procedures(28 days after intervention)
  • Stone-free rate(28 days after intervention)
  • Duration of stay(28 days after intervention)
  • Complications(28 days after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Waheed Fawzy Abdelrasol

Lecturer of Urology, faculty of medicine, New Vally University

New Valley University

研究点 (2)

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