跳至主要内容
临床试验/CTRI/2024/07/071294
CTRI/2024/07/071294
尚未招募
4 期

Comparison of double-J stenting versus ureteral catheters in percutaneous nephrolithotomy

未提供1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月12日最近更新:

概览

阶段
4 期
状态
尚未招募
入组人数
200
试验地点
1
主要终点
To determine if ureteral Catheters have significantly reduced stent related complications when compared with double J stenting

概览

简要总结

This randomised control trial (open label) aims at comparing the placement of uretral catheters in patient post PCNL (intervention) with those in whom double J stents have been placed (the accepted standard). The study primarily aims to determine if the stent related symptoms are significantly less in ureteral catheter arm and secondarily to determine if there is any significant increase in other post operative complications (urinary extravasation, bleeding)

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
12.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients of ages above 12 years undergoing PCNL in department of Urology in IPGMER, KOLKATA.
  • Cumulative stone diameter ≤ 4 cm No ureteral obstruction Up to two access sites Those consented to be part of study.

排除标准

  • Patient who did not gave consent for the study Patients below age of 12 years Cumulative stone diameter more than 4 cm Presence of ureteral obstruction More than 2 access sites.

结局指标

主要结局

To determine if ureteral Catheters have significantly reduced stent related complications when compared with double J stenting

时间窗: Day 1 | Day 2 | 2 Weeks

次要结局

  • To determine if ureteral catheters have comparable rates of complications for urinary extravasation and need for blood transfusion with double J stents(Day 1)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Suhan Khamar

IPGMER and SSKMH

研究点 (1)

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