The Impact of Suction-Assisted RIRS (DISS Versus FANS) on Postoperative Infection Rate and Stone-Free Rate After Treatment of Medium Sized Renal Stones
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Stone-Free Rate
研究概览
简要总结
Kidney stones are a common health problem and may recur frequently, which can affect quality of life and kidney function. Retrograde intrarenal surgery (RIRS) is a minimally invasive treatment used for renal stones, but treatment of medium-sized stones may be associated with longer operative time, impaired visibility during surgery, residual stone fragments, and postoperative infectious complications caused by increased intrarenal pressure.
Suction-assisted retrograde intrarenal surgery (RIRS) techniques have been developed to improve surgical efficiency and safety by facilitating continuous removal of stone fragments and helping control intrarenal pressure. Two commonly used suction-assisted approaches are direct in-scope suction (DISS) and flexible and navigable suction ureteric access sheath (FANS). However, there is limited prospective randomized evidence directly comparing these two techniques.
This randomized prospective clinical study aims to compare direct in-scope suction (DISS) versus flexible and navigable suction ureteric access sheath (FANS) in adult patients with medium-sized renal stones measuring 2 to 3 cm who are undergoing retrograde intrarenal surgery (RIRS). Participants will be randomly assigned to one of the two suction-assisted techniques. The study will evaluate whether flexible and navigable suction ureteric access sheath (FANS) provides better outcomes than direct in-scope suction (DISS) in terms of stone-free rate and postoperative infection rate.
The primary outcome is stone-free status assessed by postoperative imaging. Secondary outcomes include operative time, intraoperative visibility, and postoperative complications, particularly infection and urosepsis. The study hypothesis is that suction-assisted retrograde intrarenal surgery (RIRS) using the flexible and navigable suction ureteric access sheath (FANS) technique will result in a higher stone-free rate and a lower postoperative infection rate compared with direct in-scope suction (DISS) in the management of medium-sized renal stones.
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
盲法说明
This is an open-label surgical trial. The operating urologist cannot be masked because the two suction-assisted retrograde intrarenal surgery techniques require different instruments and procedural steps. Participants will undergo one assigned procedure according to the study protocol. Outcome assessment will be based on predefined clinical, laboratory, and imaging measures.
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 aged 18 to 60 years
- •Radiologically confirmed renal stones measuring 2 to 3 centimeters
- •Eligible for retrograde intrarenal surgery
- •Normal renal function as evidenced by normal serum creatinine
- •Able and willing to provide written informed consent
排除标准
- •Pregnancy or lactation
- •Active urinary tract infection at the time of enrollment
- •Bleeding disorders or coagulopathies that contraindicate surgical intervention
- •Anatomical malformations affecting the urinary tract
- •Solitary kidney
- •Inability or unwillingness to provide informed consent
研究组 & 干预措施
In-Scope Suction Group
Participants assigned to this arm will undergo suction-assisted retrograde intrarenal surgery using direct in-scope suction. A single-use flexible ureteroscope with suction function will be used, and direct suction will be applied through the working channel during laser lithotripsy. Negative pressure will be maintained between 2 and 7 kilopascals and adjusted intraoperatively according to visibility and fragment evacuation. Laser lithotripsy will be performed using a holmium:yttrium-aluminum-garnet laser with dusting and popcorn techniques, followed by placement of a 6 French double-J ureteral stent.
干预措施: Direct In-Scope Suction (Procedure)
Flexible and Navigable Suction Ureteric Access Sheath Group
Participants assigned to this arm will undergo suction-assisted retrograde intrarenal surgery using a flexible and navigable suction ureteric access sheath. The sheath will be inserted under guidewire guidance and connected to a vacuum device. Negative pressure will be maintained between 2 and 7 kilopascals and adjusted intraoperatively according to visibility and fragment evacuation. Laser lithotripsy will be performed using a holmium:yttrium-aluminum-garnet laser with dusting and popcorn techniques. Suction will be applied intermittently through the sheath to facilitate fragment evacuation, followed by placement of a 6 French double-J ureteral stent.
干预措施: Flexible and Navigable Suction Ureteric Access Sheath (Procedure)
结局指标
主要结局
Stone-Free Rate
时间窗: At 1 month after surgery
Stone-free status will be assessed by postoperative imaging using kidney, ureter, and bladder radiography and non-contrast computed tomography. Clinically insignificant residual fragments will be defined as residual fragments measuring 2 to 3 millimeters or less.
次要结局
- Postoperative Infection Rate(Within 1 month after surgery)
- Operative Time(During surgery (Intraoperatively))
- Intraoperative Visibility Score(During surgery (Intraoperatively))
- Postoperative Complication Rate(Within 1 month after surgery)
研究者
Ahmed Samy Abd Elmawgod Ali Marey
Resident of Urology
Ain Shams University