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临床试验/NCT07247617
NCT07247617招募中不适用

Semi-rigid Ureteroscopy Versus Flexible Ureteroscopy in Upper Third Ureteric Stones Management: a Prospective Randomized Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
- Stone-free rate at 3 months duration

研究概览

简要总结

To compare the efficacy, safety, success rate, operative time, and cost-effectiveness of flexible ureteroscopy versus semirigid ureteroscopy in the management of upper ureteric stones smaller than 2 cm.

The investigators' main concern in this study is Upper third ureteric stones to determine which cases can be treated with Semi-Rigid Ureteroscopy, and which one needs flexible ureteroscopy. This depends on several factors:

  1. Division of the upper third of the ureter
  2. Stone size
  3. Stone impaction
  4. Surgeon experience
  5. Anesthesia
  6. Ureteric dilatation above the stone
  7. Mini endoscopy

详细描述

Ureteroscopy (URS) is a widely accepted minimally invasive approach for treating ureteric stones, particularly proximal (upper) ureteral stones. Options include rigid, semirigid (often grouped as one), and flexible ureteroscopes. Flexible ureteroscopy allows deflection and access to the proximal ureter and intrarenal collecting system, facilitating treatment of stones that are difficult to reach with rigid ureteroscopes due to anatomical constraints or stone migration. Semirigid ureteroscopy has shown good efficacy, particularly for stones amenable to direct access without complex deflection, offering shorter operative times and lower costs. Studies report stone-free rates of approximately 90-93% for flexible URS and 81-90% for semirigid URS, with flexible URS having somewhat higher success in accessing stones and managing fragment migration. However, flexible URS typically incurs higher costs and longer operative times. Semirigid ureteroscopy is often the initial approach for upper ureteric stones where anatomy, stone size (<2 cm), and location allow straightforward access.

  • Flexible ureteroscopy is preferred when stones are located higher in the ureter, difficult to reach by semirigid scopes, or if stone migration into the kidney occurs. It is also favored when more maneuverability is required to treat complex anatomy or large stones.
  • Both modalities use holmium laser lithotripsy for stone fragmentation.
  • Treatment choice also depends on surgeon preference, availability of equipment, and cost considerations.

Despite advances, there is ongoing debate about the optimal first-line ureteroscopic approach for upper ureteric stones, balancing efficacy, safety, cost, and procedure time. Comparing flexible and rigid/semirigid ureteroscopy outcomes informs treatment algorithms, improving patient care and resource utilization, especially in differing healthcare settings.

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

  • Patients ≥18 years
  • upper ureteric stone

排除标准

  • Associated renal stones
  • Any contraindications to Anesthesia

结局指标

主要结局

- Stone-free rate at 3 months duration

时间窗: 3 months

次要结局

未报告次要终点

研究者

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

Omar Ahmed Hamada Ali

Urology Resident

Assiut University

研究点 (1)

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