Comparative Study of Access Sheaths With Flexible Tips and Suction Versus Conventional Access in Endourology: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Operative Time
研究概览
简要总结
Kidney stones located in the kidney are commonly treated using a minimally invasive procedure called retrograde intrarenal surgery (RIRS). During this procedure, a ureteral access sheath is often used to facilitate repeated access to the kidney, improve visualization, and allow irrigation fluid to drain.
Newer access sheaths have been developed with flexible distal tips and built-in suction capabilities, which may help reduce operative time by improving visibility and removing stone fragments and irrigation fluid more efficiently.
This prospective randomized study compared a flexible and navigable suction ureteral access sheath with a conventional ureteral access sheath in adult patients undergoing RIRS for kidney stones measuring 10 mm or larger. Participants were randomly assigned to one of the two access sheath types.
The primary objective of the study was to evaluate whether the use of a suction-enabled access sheath reduces operative time. Secondary objectives included assessment of complications, length of hospital stay, stone-free rate, and need for additional interventions.
详细描述
This was a prospective, single-center, randomized controlled trial conducted at a tertiary referral endourology center. Adult patients (≥18 years) with renal stones measuring 10 mm or greater and scheduled to undergo retrograde intrarenal surgery (RIRS) under general anesthesia were eligible for inclusion.
Participants were randomized in a 1:1 ratio to undergo RIRS using either a flexible and navigable suction ureteral access sheath (FANS group) or a conventional ureteral access sheath (control group). Randomization was performed using a computer-generated sequence with allocation concealment via sealed opaque envelopes. Blinding of the operating surgeon was not feasible due to the nature of the devices used.
All procedures were performed by experienced endourologists using standardized surgical techniques. Flexible ureteroscopy was performed with a digital ureteroscope, and stone fragmentation was achieved using a Holmium:YAG laser in dusting mode. In the suction access sheath group, negative pressure suction was applied through the sheath according to manufacturer guidelines. Irrigation parameters were standardized across both study arms.
The primary outcome measure was operative time, defined as the interval from insertion of the first endoscopic instrument through the urethra to removal of the final instrument at the end of the procedure. Secondary outcome measures included intraoperative and postoperative complications (classified using the Clavien-Dindo system), ureteral wall injury, length of hospital stay, stone migration, and stone-free rate. Stone-free status was defined as the absence of residual fragments greater than 2 mm on postoperative imaging.
Preoperative assessment included non-contrast computed tomography to evaluate stone size, location, and burden. Postoperative imaging was performed using kidney-ureter-bladder radiography or renal ultrasound approximately two weeks after surgery.
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
- •Age 18 years or older
- •Presence of single or multiple renal stones measuring 10 mm or greater
- •Eligible for retrograde intrarenal surgery under general anesthesia
- •Ability to provide written informed consent
排除标准
- •Active urinary tract infection at the time of surgery
- •Known bleeding disorders
- •Solitary kidney
- •Anatomical abnormalities of the urinary tract that could affect ureteroscopic access
研究组 & 干预措施
Flexible and Navigable Suction Ureteral Access Sheath (FANS)
Participants underwent retrograde intrarenal surgery using a flexible and navigable ureteral access sheath with integrated suction capability.
干预措施: Flexible and Navigable Suction Ureteral Access Sheath (FANS) (Device)
Conventional Ureteral Access Sheath
Participants underwent retrograde intrarenal surgery using a standard, non-suction ureteral access sheath.
干预措施: Conventional Ureteral Access Sheath (Device)
结局指标
主要结局
Operative Time
时间窗: During the surgical procedure
Operative time was defined as the duration from insertion of the first endoscopic instrument through the urethra to removal of the final instrument at the end of the procedure.
次要结局
- Intraoperative and Postoperative Complications(Perioperative period (Day of surgery through postoperative Day 30).)
- Stone-Free Rate(Two weeks after surgery)
- Length of Hospital Stay(From end of surgery until hospital discharge (typically 1-3 days).)
- Ureteral Wall Injury(During the surgical procedure)