Percutaneous Nephrolithotomy Versus Retrograde Intrarenal Surgery for Management of Stones in Solitary Kidney: Assessment of Outcomes and Complications Through a Prospective Non Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- stone free rate
研究概览
简要总结
Few studies compared PCNL and RIRS for stones in solitary kidney. Current guidelines do not provide clear recommendations concerning the management of renal stones in patients with solitary kidney. The study aims to compare the safety and efficacy of the use of percutaneous nephrolithotomy (PCNL) and flexible ureteroscopy in the treatment of renal stones _ ≤ 3 cm in largest diameter through a prospective non randomized study in the period between August 2024 and August 2026. Stone-free rate will be assessed by NCCT done at 1st day postoperative and after 3 months. For Evaluation of kidney function postoperatively, creatinine clearance will be done after 1month and renal isotope scan will be done after 3 months. In addition, the results will be compared to the data of the patients with solitary kidney and renal stones who were retrospectively treated by PCNL or RIRS in the period between 2002 and 2024. The cases should fulfil the same inclusion criteria of the prospective study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with anatomical or functional solitary kidney.
- •Renal stones ≤ 3 cm in largest diameter- as measured by non-contrast spiral CT
- •Age ≥ 18 years.
排除标准
- •Patients who did not meet the above criteria.
- •bleeding diathesis or those on anticoagulant therapy.
- •concomitant pathology as ureteric stricture or renal congenital anomalies .
结局指标
主要结局
stone free rate
时间窗: within 3 months after surgery
Stone-free status: it will be assessed by NCCT (defined as the absence of any stones or presence of only clinically insignificant residual stones \< 4 mm as measured by NCCT). Sub classified to * Initial stone free rate (1st day postoperative) * Final stone free rate (after 3 months)
次要结局
- complication rate(within 30 days after surgery)
- number of sessions(3 months after surgery)
- renal function evaluation(within 3 months after surgery)
- auxiliary procedures(within 3 months after surgery)
- hospital stay(from date of surgery until hospital discharge ( up to 30 days ))
- renal function evaluation(within 1 month after surgery)