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临床试验/CTRI/2014/03/004511
CTRI/2014/03/004511招募中不适用

Randomised control trial to compare pain during DoubleJ stent removal using Flexible cystoscope and Semirigid Ureteroscope

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2013年10月6日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
96
试验地点
1
主要终点
VAS score of pain

研究概览

简要总结

Ureteral stent mostly Double J stent (DJ stent) which are placed for various indications like  ureterescopic stone removal, PCNL, pyeloplasty, ESWL are an integral part of urological practice. The stents are usually removed after 2 to 6 weeks after the initial therapeutic procedure. Rigid cystoscope which were used for stent removal   is associated with discomfort and pain, especially in male patients because of longer urethra.Some studies had compared flexible and rigid cystoscopy in terms of patient discomfort and pain but for cystoscopy only without any adjuvant procedure.Flexible cystoscopy(FC) is associated with high initial and mantanence costs  and in a developing nation like ours cost implication are important. Soylemez et al used semirigid ureteroscope(SRU) for cystoscopy and stent removal in both male and female patients and found it comparable to flexible cystoscope with lower cost.

Till now no study has compared these different techniques for stent retrieval in male patients and no consensus is there regarding the best technique, so we designed this study as a RCT for comparing flexible cystoscope and semierigid ureteroscope for stent removal in our patients.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All adult patients 18 yrs and above with unilateral DJ stent in situ for 2-6 weeks, due for Dj stent removal.

排除标准

  • Migrated stents, Severe comorbidities, encrusted stents, Post renal transplant, Residual or bilateral stent.

结局指标

主要结局

VAS score of pain

时间窗: during and at the end of procedure

次要结局

  • operative time, VAS score of operative difficulty and complications(during the procedure)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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