Primary Ureteroscopy for Acute Obstructive Nephropathy Due to Ureteral Stones: A Prospective Non-randomized Feasibility and Safety Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- post operative complications
研究概览
简要总结
Ureteroscopy (URS) is a widely used minimally invasive procedure for the management of ureteral and renal stones (1). While the procedure is generally safe and effective, patient factors such as renal function, operative time, and ASA classification may influence outcomes (2).
Ureteral stones were found to be associated with deteriorated kidney function in affected patients (3). In cases of elevated urea and creatinine levels, pre-stenting of ureteroscopy was indicated (4). Limited number of studies have directly assessed the primary ureteroscopy without preoperative stenting outcomes in patients with normal versus deteriorated renal function. Understanding the impact of renal function on URS outcomes can help. A single procedure translates to reduced patient burden through fewer hospital visits, less time spent in the operating room, and a quicker return to daily activities, thus improving comfort and convenience. This approach also yields cost savings by eliminating the expenses associated with a second procedure, including hospital stays, anesthesia, and surgical supplies. Moreover, immediate stone removal via primary URS offers faster symptom relief and avoids potential stent-related complications such as pain, infection, and migration. However, the decision to forego staging must be carefully weighed against individual patient risk factors and stone complexity, as those with severe obstruction, infection, or compromised renal function may still benefit from pre-stenting to optimize procedural safety and outcomes.
This study aims to evaluate whether elevated creatinine levels influence stone-free rates, complication rates, and procedural success in patients undergoing primary URS.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Adults (>18 years) with acute unilateral ureteral obstruction confirmed by:
- •Non-contrast CT (stone size ≥5mm)
- •Hydronephrosis on ultrasound
- •Planned for primary URS (no prior stenting/nephrostomy)
- •Renal function eligibility:
- •Acute deterioration (elevated serum Cr and urea) serum creatinine ≥1.3 mg/dL but less than 5 mg/dL
排除标准
- •Systemic contraindications to URS:
- •Uncorrected coagulopathy (INR >1.5)
- •Active UTI/sepsis (requiring drainage-first approach)
- •Severe cardiopulmonary compromise (ASA class ≥IV)
- •Patients with hypercalcemia.
- •hyperkalemia >6.5 mEq/L
- •Metabolic acidosis (pH <7.1)
- •Patients with pulmonary edema.
- •Patients with uremic encephalopathy.
- •Bilateral obstruction
- •Known ureteral stricture distal to stone
研究组 & 干预措施
Group 1
Patients presenting with acute obstructive uropathy and uremic renal impairment (defined as serum creatinine ≥1.3 mg/dL)
干预措施: Ureteroscopy (Procedure)
Group2
Patients with normal renal function (eGFR ≥60 mL/min/1.73m²) undergoing primary URS for ureteral stones.
干预措施: Ureteroscopy (Procedure)
结局指标
主要结局
post operative complications
时间窗: 3 month
次要结局
未报告次要终点
研究者
Mohamed Mostafa Khedr
Residant doctor at Assiut university hospital
Assiut University
