Comparison of Lithotomy Versus Lateral Position in Retrograde Intrarenal Surgery for Lower Calyceal Stones Less Than 2 cm: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Stone Free Rate
研究概览
简要总结
Retrograde intrarenal surgery (RIRS) is an established minimally invasive treatment for renal stones, particularly for lower calyceal stones less than 2 cm, offering acceptable stone-free rates with low morbidity.
However, stone clearance in the lower calyx remains technically challenging due to unfavorable anatomy, limited scope deflection, and gravity-dependent fragment retention. Patient positioning during RIRS has been suggested as a modifiable factor that may influence endoscopic access, stone relocation, and surgical ergonomics.
The lithotomy position is conventionally used during RIRS, while the lateral position has been proposed to facilitate stone migration and improve lower calyceal access through gravitational assistance. Existing studies comparing patient positioning during RIRS are limited, with most evidence derived from retrospective analyses or non-randomized designs.
Therefore, this randomized controlled trial aims to compare lithotomy versus lateral positioning during RIRS for lower calyceal stones less than 2 cm in terms of operative and clinical outcomes.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years.
- •Single or multiple lower calyceal renal stones with stone size <2 cm confirmed by NCCT.
- •Negative urine culture.
- •Presented cases.
排除标准
- •Multiple stones involving renal pelvis or other calyces.
- •Anatomical anomalies affecting ureteroscope access (horseshoe kidney, malrotation, ureteral strictures).
- •Pregnancy.
- •Prior ipsilateral renal surgery.
结局指标
主要结局
Stone Free Rate
时间窗: 1 month
Stone-free rate (SFR), defined as no clinically significant residual stones on non-contrast 3-mm-cuts CT, measured as yes or no
次要结局
- Operative time(The operative time)
- Complications(1 month)
研究者
Ammar Fathi Mohamed AlOrabi
Dr
Menoufia University