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临床试验/NCT07177313
NCT07177313尚未招募不适用

Primary Ureteroscopy for Acute Obstructive Nephropathy Due to Ureteral Stones: A Prospective Non-randomized Feasibility and Safety Trial

Assiut University0 个研究点目标入组 60 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Mostafa Khedr

Residant doctor at Assiut university hospital

Assiut University

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