Safety and Efficacy of Using Traditional Ureteral Access Sheath Versus Flexible and Navigable Suction Sheath in Retrograde Intra-Renal Stone Surgery for Renal Stones ≤ 20 mm: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Stone-free rate
研究概览
简要总结
This study compares two techniques used during RIRS for the treatment of kidney stones measuring up to 20 mm. During RIRS, surgeons often use a device called a UAS to help pass instruments into the urinary system and to assist with the removal of stone fragments. A traditional UAS allows irrigation fluid and small fragments to flow out passively. A newer type, known as a suction UAS, applies controlled negative pressure to help clear stone fragments more effectively and may reduce pressure inside the kidney during the procedure.
The purpose of this study is to determine whether the suction UAS offers better clinical outcomes than the traditional UAS. The main outcomes assessed include the SFR, the duration of surgery, and complications after the procedure such as fever, sepsis, urinary infection, calyceal injury, or ureteral injury.
In this randomized study, adult patients undergoing RIRS for a single renal stone were assigned to either the suction UAS or the traditional UAS. All patients were followed after surgery to assess stone clearance and any complications. The results of this study aim to provide evidence on whether suction UAS improves safety or effectiveness in RIRS compared with the traditional approach.
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
- •Adults aged eighteen years or older
- •Male or female participants
- •Presence of a single kidney stone measuring up to twenty millimeters
- •Candidate for retrograde intrarenal surgery according to clinical evaluation
- •Able and willing to provide informed consent
排除标准
- •Active or untreated urinary infection
- •History of open kidney surgery or kidney trauma
- •Contraindications to anesthesia, including uncontrolled diabetes, severe cardiac disease, or significant coagulation disorders
- •Presence of ureteral narrowing or obstruction at the junction between the ureter and the kidney
- •Positive urine culture that does not resolve after appropriate treatment
研究组 & 干预措施
Suction Ureteral Access Sheath Group
Participants in this group underwent retrograde intrarenal surgery using a ureteral access sheath equipped with a suction mechanism. After anesthesia, a guide wire was placed and the ureter was evaluated. The suction ureteral access sheath was inserted over the guide wire and positioned inside the kidney near the stone. Controlled negative pressure was applied to improve removal of stone fragments and to maintain lower pressure inside the kidney during the procedure. Laser lithotripsy was performed, and stone fragments were aspirated through the suction system. A double-J ureteral stent was placed at the end of the procedure.
干预措施: Retrograde intrarenal surgery using a ureteral access sheath with suction (Procedure)
Traditional Ureteral Access Sheath Group
Participants in this group underwent retrograde intrarenal surgery using a traditional ureteral access sheath without suction. After anesthesia and guide wire placement, the traditional ureteral access sheath was inserted and positioned below the junction between the ureter and the kidney. Laser lithotripsy was performed in the standard manner. Stone fragments were removed passively using irrigation and by repeatedly retrieving fragments with a basket. A double-J ureteral stent was placed at the end of the procedure.
干预措施: Retrograde intrarenal surgery using a traditional ureteral access sheath (Procedure)
结局指标
主要结局
Stone-free rate
时间窗: One month after surgery
The stone-free rate represents the proportion of participants who show no residual stone fragments or only clinically insignificant small fragments on postoperative imaging. Imaging is performed using non-contrast computed tomography. Findings are classified into four categories based on fragment size: complete clearance, fragments up to two millimeters, fragments between two point one and four millimeters, and fragments larger than four millimeters. The outcome is expressed as the percentage of participants achieving complete clearance or clinically insignificant fragments.
次要结局
- Duration of surgery(During surgery)
- Readmission after surgery(Within one month after surgery)
- Need for an additional procedure(Within three months after surgery)
- Urinary infection after surgery(Within one month after surgery)
- Systemic infection after surgery(Within one month after surgery)
研究者
Hassan mahmoud hassan
Resident of Urology
Ain Shams University