Prospective Randomized Study on the Necessity of Postoperative Stenting After Ureteroscopy (URS) for Ureteral Stones.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative pain assessment
研究概览
简要总结
Comparison of routine postoperative stenting versus no stenting after ureterorenoscopy for ureteral stones to assess the necessity and impact on complication risk.
详细描述
After a ureteroscopy (URS) for the removal of ureteral stones, a double-J stent is routinely placed. Among other measures, this is intended to prevent pain caused by ureteral swelling, small residual fragments, blood clots, and potential drainage obstructions, which could lead to colic or fever. However, the evidence supporting the benefit of this practice is limited. At the same time, many patients report discomfort due to the stent (e.g., flank pain, dysuria, frequent urination, hematuria), which can significantly impact their 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
- •Age 18 years or older
- •Patients with ureteral stones scheduled for ureteroscopy (URS) and stone removal
- •Previous pre-stenting
- •Informed Consent as documented
排除标准
- •Complex ureteral conditions (e.g., known ureteral strictures)
- •Impacted stones
- •Solitary kidney
- •Patients with significant renal stones (>3mm)
- •Previous ureteral surgeries (except endoscopic stone treatments)
- •Pregnancy or suspected pregnancy
研究组 & 干预措施
No-Stent Group
No postoperative double-J catheter following ureterorenoscopy.
干预措施: No Double-J catheter insertion (Other)
Stent Group
Routine postoperative double-J catheter insertion following ureterorenoscopy.
干预措施: Double-J catheter (Procedure)
结局指标
主要结局
Postoperative pain assessment
时间窗: up to 4 weeks postoperative
Assessment of postoperative pain will be conducted using the Visual Analogue Scale (VAS) and the study-specific mobile application HEATMAP (Byldr GmbH, Switzerland). The primary outcome is the difference between the pain scores recorded by the VAS and those recorded by the HEATMAP application at predefined postoperative time points \[both measured on a scale from 1-10, with higher scores indicating greater pain\].
次要结局
- Length of stay [days](During the hospital stay, on average 2 days)
- Pain Assessment(pre-/peri-/postoperative)
- Pain Management(pre-/peri-/postoperative)
- Secondary need of double-J catheter(up to 4 weeks postoperative)
- Procedure related readmissions(up to 4 weeks postoperative)
- Procedure related reoperations(up to 4 weeks postoperative)
- Comprehensive Complication Index(up to 4 weeks postoperative)
研究者
Lukas J Hefermehl
Principal Investigator
Kantonsspital Baden