A Comparative Study Between Sheathless RIRS, Traditional Access Sheath RIRS, and Suction Access Sheath RIRS in the Management of Renal Stones ≤ 2 cm: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Stone-free rate assessed by non-contrast computed tomography of the urinary tract
研究概览
简要总结
This completed randomized clinical study was designed to compare three different techniques of retrograde intrarenal surgery (retrograde intrarenal surgery) for the treatment of kidney stones that are 2 centimeters or smaller. Retrograde intrarenal surgery is a minimally invasive procedure in which a flexible scope is passed through the urinary tract to reach the kidney and fragment the stone.
The clinical study included three groups of patients. The first group underwent retrograde intrarenal surgery using a traditional ureteral access sheath, which is a hollow tube placed in the ureter to facilitate the passage of instruments and help control pressure inside the kidney. The second group underwent retrograde intrarenal surgery using a suction ureteral access sheath, which combines the function of a traditional sheath with gentle suction to help remove stone fragments and reduce internal pressure. The third group underwent sheathless retrograde intrarenal surgery, in which the flexible surgical scope is inserted directly without the use of any ureteral access sheath.
The purpose of this clinical study was to determine whether these three approaches differ in terms of stone clearance, operative time, intraoperative complications such as bleeding or fluid leakage, and early postoperative complications such as fever or infection. All participants were adults with a single kidney stone between 1 and 2 centimeters, normal kidney function, and no active infection or anatomical abnormalities. All procedures were performed at Ain Shams University Hospitals using the same surgical equipment and technique to ensure comparability between groups.
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
- •Adult patients aged 18 years or older.
- •Symptomatic unilateral single renal stone with a maximal diameter from 1 centimeter to 2 centimeters.
- •Normal kidney function based on routine laboratory tests.
- •Patients willing and able to provide written informed consent to participate in the clinical study.
排除标准
- •Patients with active urinary tract infection (UTI) until appropriate treatment is completed and infection is cleared.
- •Patients with anatomical abnormalities of the urinary tract (for example, congenital or acquired structural abnormalities).
- •Pregnant patients.
- •Patients who are medically unfit for general anesthesia.
- •Patients with multiple renal stones in the same kidney or bilateral renal stones.
结局指标
主要结局
Stone-free rate assessed by non-contrast computed tomography of the urinary tract
时间窗: One month after surgery (non-contrast computed tomography of the urinary tract performed approximately 30 days postoperatively)
Stone-free status is evaluated using non-contrast computed tomography of the urinary tract performed after surgery. Residual stone fragments are classified into four grades: Grade A, no stones detected (absolute stone-free); Grade B, residual fragments less than or equal to 2 millimeters (relative stone-free); Grade C, residual fragments 2.1 to 4 millimeters (relative stone-free); and Grade D, residual fragments greater than 4 millimeters (significant residual stones). The primary endpoint is the proportion of patients achieving stone-free status, defined as Grade A (absolute stone-free) and, in a secondary analysis, Grades A to C combined (clinically insignificant residual fragments).
次要结局
- Operative time for retrograde intrarenal surgery(During the surgical procedure on the day of surgery)
研究者
AbdAlhameed Naser
Resident of Urology
Ain Shams University