跳至主要内容
临床试验/CTRI/2020/07/026421
CTRI/2020/07/026421已完成不适用

A Randomised clinical trial comparing outcome of Stented versus Non-stented strategy in uncomplicated Ureteorenoscopic lithotripsy (URSL)

depatment of urology1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年8月7日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
2) To assess incidence of complications in both group study subjects after URSL and make comparison.

研究概览

简要总结

Ureteroscopic lithotripsy, extracorporeal shock wave lithotripsy (ESWL), medical therapy, percutaneous nephrolithotomy and laparoscopic surgery are all the indicated for the treatment of ureteral stones. URSL and ESWL are the most widely used techniques to clear stones with high degree of success [3].

Procedure of choice for treating ureteric calculi especially mid and lower ureteric calculi is ureterorenoscopic lithotripsy.There are specific indications for D J placement  after URSL such as ureteral injury ureteral edema with or without stone impaction, ureteral perforation, previous history of or present renal failure, URSL done in  solitary kidney or a transplant kidney.

Despite such indications for DJ stenting, stenting is being injudiciously by urologist inspite of morbidity associated with stenting. Worldwide data shows 13% of urologists place DJ stent after every endoscopic stone surgery (URSL/RIRS) and 66% of the urologists place a DJ stent more than half of the times after URSL/RIRS[9]. This numbers would be further higher in India.

There is still controversy regarding placement of ureteral stent after uncomplicated URS stone surgery.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Unilateral Solitary Calculi Size <15 mm.

排除标准

  • History of pyelonephritis Solitary kidney Ureteric injury Concomitant stone at other place in urinary tract Ureteric stricture.

结局指标

主要结局

2) To assess incidence of complications in both group study subjects after URSL and make comparison.

时间窗: post operative day 3, week 1, week 2 week 3, week 4 after surgery

1) To study and compare the sociodemographic and morbidity parameters among the study subjects in two groups.

时间窗: post operative day 3, week 1, week 2 week 3, week 4 after surgery

3) To determine the average stone free rate in both the groups.

时间窗: post operative day 3, week 1, week 2 week 3, week 4 after surgery

次要结局

  • 1) need of analgesic in post operative period.(2) mean hopspital stay.)

研究者

发起方
depatment of urology
申办方类型
Government medical college

研究点 (1)

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