跳至主要内容
临床试验/NCT03207659
NCT03207659Unknown不适用

Dusting vs Basketing in RIRS: a Single-center Prospective Randomised Trial

Guohua Zeng1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2017年8月1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
136
试验地点
1
主要终点
Stone free rate (SFR)

研究概览

简要总结

The investigator aims to perform a prospective and randomized controlled trial comparing the safety and efficacy of active basket extraction of fragments and stone dusting during the RIRS.

详细描述

RIRS has been widely adopted and used by urologists worldwide in the management of renal stones due to less invasiveness and efficacy, especially in small to moderate-sized renal stones. RIRS has several advantages over SWL for stones less than 2 cm diameter. Most importantly, removing the stone in one session without the need for other treatment modalities.

Furthermore, the application of RIRS has expanded to larger stones reaching up to 35 mm in some cases,in spite of not being the first line therapy for the larger stones. RIRS has advantages over the PCNL especially concerning complications. Namely lower or no bleeding events and the less invasiveness of RIRS.

Options for the treatment of intrarenal stones include fragmenting the stone then extracting large fragments using a basket or dusting the stone into very small fragments then leaving the (dust) to pass spontaneously.

The idea of dusting in RIRS emerges as a counterpart of the originally taught fragmentation and basketing of the stones. Aiming to reduce multiple entries and exits for the renal system and ultimately not requiring UAS or baskets during the surgery. Thus theoretically decreasing operative time and costs with the same SFRs, In addition to minimizing the risk of ureteral injury .

So there is a debate amongst surgeons whether to laser the stone to dust or fragment and retrieve intra-renal fragments. EAU guidelines on the surgical management of urolithiasis stated that dusting strategies should be limited to the treatment of large renal stones. Without clearly differentiating between dusting or fragmentation and basketing. Cho et al; favored fragmentation technique especially for large renal stones because the dust in dusting technique may affect visualization and obscure small stone fragments. But this was an opinion and not built on a direct comparative study.

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 must be a suitable operative candidate for RIRS
  • Age ≥18 years
  • Normal renal function
  • ASA score Ⅰ and Ⅱ
  • Single renal 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

  • Pregnant subjects
  • Uncorrected coagulopathy and active urinary tract infection (UTI)
  • prior ipsilateral endourological procedure history, such as RIRS, PCNL, URS and URL
  • Patients who underwent transplant or urinary diversion.
  • Congenital abnormalities.

研究组 & 干预措施

Dusting

Experimental

small stones will be left to pass spontaneously.

干预措施: Dusting in RIRS (Procedure)

Basketing

Experimental

stones will be actively extracted.

干预措施: Basketing in RIRS (Procedure)

结局指标

主要结局

Stone free rate (SFR)

时间窗: 4-6 weeks after surgery

To assess for stone-free rate using K.U.B. (kidney-ureter-bladder) plain radiograph and renal ultrasound. If there is a discrepancy in follow up imaging between the presence of residual stones or fragments between the KUB and renal ultrasound, the KUB will be considered the reference standard for small fragments less than 4mm unless the stone composition is uric acid. If fragments 5 mm or larger exist or uric acid it will be up to the discretion of the surgeon to order a CT to better delineate the presence of residual stones and their impact on the clinical management of that patient.

次要结局

  • Complication rates(intraoperatively or 48h postoperatively)
  • Operating time(intraoperatively)

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)

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