跳至主要内容
临床试验/CTRI/2023/04/051799
CTRI/2023/04/051799招募中不适用

A Randomized Controlled Study Comparing Transperitoneal vs Retroperitoneal Laparoscopic Ureterolithotomy.

NAZARETH HOSPITAL1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年4月27日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
54
试验地点
1
主要终点
STONE FREE RATE

研究概览

简要总结

Till date, there has been no consensus as to which method of laparoscopic ureterolithotomy is preferred.

The purpose of this study is to evaluate difference between transperitoneal v/s retroperitoneal approach used for Laparoscopic ureterolithotomy and if there is any advantage of one technique over the other. This randomized control study will compare the outcome of the two approaches.

Patients with >/= to 10mm ureteric calculus will be randomly assigned to either of the approach groups and evaluated on the basis of peri-operative outcomes and differences and followed up for a period of 3months.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age more than 18years.
  • Patient with ureteric calculus of size ≥10mm.

排除标准

  • Pregnant women.
  • Congenital renal and/or ureteric anomalies at the stone site.
  • Patients not fit for surgery.
  • Patient having non-functioning kidney.
  • Patient not consenting for surgery.

结局指标

主要结局

STONE FREE RATE

时间窗: STONE FREE RATE WILL BE ASSESED ON POSTOPERATIVE DAY 1, 6WEEKS AND 3 MONTHS FOLLOWING SURGERY.

次要结局

  • INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS(3 MONTHS)

研究者

申办方类型
Other [GENERAL HOSPITAL]

研究点 (1)

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