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临床试验/NCT05633030
NCT05633030尚未招募不适用

Ureteral Access Sheath or Percutaneous Nephrostomy During Flexible Ureteroscopy: Which is Better?

Benha University0 个研究点目标入组 100 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
intra-operative complications

研究概览

简要总结

we aim to compare the safety and efficacy of flexible ureteroscopy with ureteral access sheath (group A) in comparison with flexible ureteroscopy without UAS but with PCN insertion (group B) either intra or post operaively by recording all data and the benefits , also comparing the drawbacks on each group

详细描述

A prospective randomized controlled study will be conducted at benha university hospitals on adult patients with renal and, or upper ureteric stones which will meet the inclusion criteria will participate in the study comparing usage of ureteral access sheath and percutaneous nephrostomy during flexible ureteroscopy. After filling out the informed consent form, patients will be randomly assigned to one of the two groups.

Group A: 50 patients will be operated using UAS during flexible ureteroscopy. Group B: 50 patients will be operated using PCN during flexible ureteroscopy.

Inclusion/Exclusion criteria:

Inclusion criteria consists of adult patients with upper ureteric stones and mild hydronephrosis or renal pelvic stones less than 20 mm with mild hydronephrosis.

Exclusion criteria include patients with active urinary tract infection and patients with uncontrolled coagulable status.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

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 with upper ureteric stones and mild hydronephrosis or renal pelvic stones less than 20 mm with mild hydronephrosis

排除标准

  • patients with active urinary tract infection and patients with uncontrolled coagulable status

结局指标

主要结局

intra-operative complications

时间窗: 3 mothes

Operative time, intra-operative complications (bleeding, perforation, incompletion of procedure) and hospitalization periods

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

mohamed abdelrahman alhefnawy

assistant professor

Benha University

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