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临床试验/NCT03932370
NCT03932370已完成不适用

Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones 2 Cm or Less; A Randomised, Comparative Study.

Assiut University1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2019年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
118
试验地点
1
主要终点
initial stone clearance

研究概览

简要总结

Management of nephrolithiasis is evolving rapidly, and various minimally-invasive urological procedures are currently available for treating patients with renal stones, including extracorporeal shockwave lithotripsy (ESWL), flexible ureteroscopy (f-URS) and miniaturised percutaneous nephrolithotomy (mini-PCNL).

Despite being the only truly-non-invasive, outpatient procedure, stone-free rates (SFRs) of ESWL are lower than both mini-PCNL and f-URS. Furthermore, ESWL has several limitations, such as pregnancy; uncorrected coagulopathy;aortic aneurism; severe obesity; large stone burdens (>2cm); stones with high densities (>970/1000 Hounsfield units); ESWL-resistant stone compositions; lower calyceal stones with unfavourable anatomical criteria; and stones in calyceal diverticula; Morbidities of the conventional PCNL are significantly minimised by using less access diameters in PCNL while providing comparable SFRs. Additionally, Mini and Micro PCNL result in shorter hospital stay and higher tubeless rates compared to conventional PCNL.

Flexible ureteroscopy has been increasingly used as a primary modality for treatment of renal stones with significantly lower complication rates than PCNL and mini-PCNL in terms of less bleeding and transfusion rates, shorter hospital stay and less postoperative pain. Additionally, f-URS is the only treatment modality of nephrolithiasis that can be safely and effectively used in patients with bleeding tendency, as well as pregnant women; moreover, its outcomes are not affected by obesity. Nevertheless, its poor durability and high costs remain major limitations for f-URS, especially in developing countries.

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
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age above than 15 years
  • Renal stone(s) with total burden of 2 cm or less
  • Signature on written, informed consents with the details of this study requirements.
  • Inappropriateness or failure of ESWL (examples of ESWL inappropriateness: patient preference; distal obstruction; contraindications of ESWL)

排除标准

  • Uncorrectable bleeding diathesis
  • Current pregnancy

结局指标

主要结局

initial stone clearance

时间窗: 24 hours after the operation

Number of participants who has been totally cleared of stones as measured by KUB and ultrasound

final stone clearance

时间窗: 90 days after the operation

Number of participants who has been totally cleared of stones as measured by non-contrast CT

次要结局

  • Haemoglobin drop(within 24 hours)
  • Operative time(Within 24 hours)
  • Hospital stay(Within a week from the operation)

研究者

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

Amr Esam Saad Mohamed Darwish

assistant lecturer of urology

Assiut University

研究点 (1)

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