Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Stone free rate
研究概览
简要总结
Flexible ureterorenoscopy (FURS) is now recommended for the treatment of kidney stones smaller than 20 mm, as an alternative to extracorporeal shock wave lithotripsy (ESWL) and in combination with percutanous nephrolithotomy (PCNL) for stones larger than 20 mm. At the end of the operation, a ureteral drainage is put in place for the treatment of residual fragments and the inflammation following the ureteroscopy. It helps prevent obstructive symptoms and the development of strictures.
Drainage is done either by a ureteral catheter or by a double J stent. In the literature, while drainage after ureteroscopy is recommended, the criteria for choosing between these two options are not clearly defined.
The objective of this study will be to assess whether the type of postoperative drainage after URS for kidney stones can influence the perioperative outcomes and health-related quality of life.
详细描述
Flexible ureterorenoscopy (FURS) is now recommended for the treatment of kidney stones smaller than 20 mm, as an alternative to extracorporeal shock wave lithotripsy (ESWL) and in combination with percutanous nephrolithotomy (PCNL) for stones larger than 20 mm. At the end of the operation, a ureteral drainage is put in place for the treatment of residual fragments and the inflammation following the ureteroscopy. It helps prevent obstructive symptoms and the development of strictures.
Drainage is done either by a ureteral catheter or by a double J stent. In the literature, while drainage after ureteroscopy is recommended, the criteria for choosing between these two options are not clearly defined.
The objective of this study will be to assess whether the type of postoperative drainage after URS for kidney stones can influence the perioperative outcomes and health-related quality of life.
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
- None
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
- •1- Adult patients (aged >18 years) 2- Undergo unilateral uncomplicated retrograde intrarenal surgery (RIRS) using flexible ureterorenoscopy.
排除标准
- •Residual ureteral or renal stones after the procedure as documented by the surgeon
- •Patients who will need auxiliary procedures (ESWL , re-FURS or PCNL)
- •Preoperative febrile UTI
- •pregnancy or breastfeeding
- •Bilateral ureteroscopic surgery
- •Single kidney
- •Chronic kidney disease
- •Cardiovascular or cerebrovascular disease
- •Hepatic dysfunction
- •Other acute medical conditions as acute gastroenteritis, osetoarthritis that might influence the patient QoL
研究组 & 干预措施
Ureteral catheter
This group will receive ureteral catheter for 2 days after the procedure
干预措施: Flexible ureteroscopy for renal calculi less than 20 mm (Procedure)
Indwelling double J stent
This group will receive indwelling double J stent for 2-4 weeks after the procedure
干预措施: Flexible ureteroscopy for renal calculi less than 20 mm (Procedure)
结局指标
主要结局
Stone free rate
时间窗: 12 weeks after the procedure
presence of residual fragments on non contrast computed tomography
次要结局
- perioperative complications(First 3 days postoperative)
- Postoperative pain by visual analogue scale(first 24 hours postoperatively)
研究者
Amr Abdel-Lateif El-Sawy
Principal Investigator
Mansoura University