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