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临床试验/NCT05299996
NCT05299996Unknown不适用

Flexible URS in Management of Renal Stones in Anomalous Kidney, A Prospective Case Series Study

Assiut University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年4月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
stone free rate post-operative

研究概览

简要总结

The urotheliasis is a common problem encountered daily by all urologists worldwide with rates up to 13% in North America, 9% in Europe and 5% in Asia . The urotheliasis is treated by conservation, medical treatment and surgery according to many factors . Anomalies in the kidney happens due to failure in ascending , fusion, rotation or all together, horse-shoe kidney is the most common example , found in one of 400 patients . PCNL and URS are the golden standard method for stone extraction worldwide, since their introduction 1975 by Fernstrom and Johansson & Arthur Smith respectively in normal kidney .Since the development of the endourological procedures and instrument , continuous updates and upgrades have been applied ,such as enhancing the optical systems ,reducing the diameter, navigation (deflection angles) and stone fragmentation .Stone treatment in anomalous kidney is more demanding, requires more skills and training . The flexible ureterorenoscopy has some problems first the cost but this problem is being now solved by the use of disposable scopes , second the skills it requires , third the possibility of sepsis is higher . To our knowledge most of the studies in the literature are retrospective, carrying some weakness in them. There is no agreed-upon therapeutic method for treatment of stones in anomalous kidney so the investigators will evaluate the role of F-URS in a prospective study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females age above 15 years.
  • Renal and ureteric stones either single or multiple wherever the site and site.
  • Pelvi-uretreic junction obstruction
  • Previous stented ureter.
  • Poorly functioning kidney.
  • Single functioning kidney.
  • Chronic kidney disease patient not on dialysis.
  • Previous operation in this kidney.
  • failed ESWL.

排除标准

  • Not fit for surgery.
  • Uncontrolled bleeding diathesis.
  • Untreated preoperative urinary tract infection (UTI).
  • non function kidney
  • skeletal abnormality

结局指标

主要结局

stone free rate post-operative

时间窗: 1 month after treatment

CT will be done to evaluate the presence or absence of stone

Change from Baseline hematocrit after 1 day postoperative

时间窗: 1 day after treatment

bleeding due to any error either surgical or non surgical

time of operation

时间窗: during the operation

the operation will be recorded.

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

Abdelrahman Mohamed Abdelkader

principal investigator , urologist , teaching assisstant

Assiut University

研究点 (2)

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