Effect of Perioperative Selective alpha1-blockers in Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Need for dilatation
研究概览
简要总结
To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.
详细描述
Objective
To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.
Patients and Methods: A randomized control trial was conducted at two high volume urological centers from September 2017 to December 2018. We enrolled 120 patients with lower ureteric stones. They were randomly divided into two groups. Group A had 58 patients who underwent non-stented ureteroscopy using Ho-YAG laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively, while Group B had 62 patients who underwent non-stented ureteroscopy and laser and received placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
patients were blinded to the type of intervention, as well as the data collector
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with single lower ureteric stones of size range between 0.5 and 2 cm
排除标准
- •Patients under the age of 18, pregnant women, or those with urinary tract infections, uncorrected bleeding disorders or coagulopathies, bilateral ureteric stones, single kidney, ureteral stricture, multiple ipsilateral ureteric stones were excluded from our study. Also, any patients who required ureteric stenting were excluded from our study.
研究组 & 干预措施
Group A
Group A had 58 patients who underwent non-stented ureteroscopy using Ho-YAG laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively
干预措施: Tamsulosin Oral Capsule (Drug)
Group B
62 patients who underwent non-stented ureteroscopy and laser and received placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Need for dilatation
时间窗: intraoperative assessment
( to evaluate whether the ureteroscope will pass easily through the ureter if not , serial ureteric dilatation will be done and documented ) it is a yes or no evaluation
次要结局
- Fever(early postoperative (2 weeks))
- Need for analgesia(first day postoperative)
- Lower urinary tract symptoms "LUTs"(early postoperative period ( 2 weeks))
- hospital stay(from few hours up to 2 days postoperative)
- Time of operation (min)(intraoperative assessment)
- Gross Hematuria(first day postoperative)
研究者
Ahmed Maher Gamil Ahmed Higazy
assistant lecturer of Urology - ain shams university
Ain Shams University