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临床试验/NCT03559738
NCT03559738已完成不适用

Comparative Study of Extracorporeal Shock Wave Lithotripsy and Ureteroscopy in Management of Upper Third Ureteral Calculi

Assiut University0 个研究点目标入组 60 人开始时间: 2016年6月1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
60
主要终点
identify best management for upper third ureter stones

研究概览

简要总结

comparative study of two treatment modalities (ureteroscopy and extracorporeal shock wave lithotripsy) in management of upper third ureteral calculi

详细描述

Large impacted upper ureteral calculus is defined as a stone located above the lower border of the fourth lumbar vertebra, remaining fixed at the same site for at least six weeks. Moreover, it is associated with hydronephrosis and/or prevents contrast medium from passing below the calculus on intravenous urography (IVU).Moreover, there is inability to pass a guidewire or catheter beyond the stone at initial attempts. The treatment for patients with large impacted proximal ureteral stone remains controversial; the surgical options for the treatment of proximal ureteral stones include extracorporeal shockwave lithotripsy (ESWL), Ureteroscopy, PCNL and rarely Laparoscopic or Open surgery. Every technique has its own limitations. The aim of this study is to compare and to evaluate the outcome and complications of two main treatments procedures for impacted proximal ureteral calculi, Extracorporeal Shock Wave Lithotripsy (ESWL) and Ureteroscopy.

Extracorporeal Shock Wave Lithotripsy (ESWL) and Ureteroscopy are two common modalities in the management of Proximal Ureteral Calculi.European Association of Urology (EAU) and American Urological Association (AUA) guidelines have recommended URS or ESWL as first-line treatment Options.ESWL is an effective and non-invasive treatment method in urolithiasis, particularly in stones located in the upper third of the ureters.However, URS is a more invasive technique when compared to ESWL, URS became the most efficient treatment method in proximal ureteral calculi after the development of small-caliber, semi-rigid and flexible endoscopes and the holmium:YAG laser. Today, the greatest dilemma faced by Urologists is to choose between ESWL and URS. A number of factors influence the final results of ESWLand if no fragmentation occurs after several unsuccessful sessions, the stone is considered ESWL-resistant; the case is deemed an ESWL-failure and the patient therefore undergoes URS.URS has been described as a salvage or second line treatment option in cases of ESWL-resistant calculi

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • The study will include patients in the age group of 18-70 years with body mass index of less than or equal to 30 kg/m2 with Upper Ureteral Calculi more than or equal to 1 cm with density about 900 - 1100 HU

排除标准

  • Patients with distal obstruction
  • Impacted stones : An impacted stone is defined as a stone where a guidewire will not pass without ancillary measures and/or a stone that does not move when forceful irrigation is applied ureteroscopically
  • Marked hydronephrosis : gross dilation/ballooning of the renal pelvis and calyces with loss of borders between the renal pelvis and calyces and renal atrophy seen as cortical thinning
  • Radiolucent stones
  • Pregnancy
  • Stones in Children
  • Spinal deformity
  • Morbid obesity
  • Patients on Aspirin

结局指标

主要结局

identify best management for upper third ureter stones

时间窗: 2 years

Matched Pair Analysis of Extracorporeal Shock Wave Lithotripsy versus Ureteroscopy for the management of Upper Ureteral Calculi with relatively small study group by comparing like-for-like Stones

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

Mostafa Mohamed Atef Abdelaziz Mostafa

Resident

Assiut University

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