A prospective study on comparision of use of Flexible Suctioning Ureteral Access Sheath versus Traditional Ureteral Access Sheath for Flexible Ureterorenoscope to treat Unilateral Renal Calculi
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Stone Free Rate, Operative Time, Intra Renal Pressure, Complication Rate.
研究概览
简要总结
This single-center, prospective, block-randomized controlled trial evaluated the efficacy and safety of the Flexible and Navigable Ureteral Access Sheath (FANS) compared to the Traditional Ureteral Access Sheath (T-UAS) in patients undergoing flexible ureterorenoscopy (F-URS) for unilateral renal calculi (10–20 mm). A total of 301 patients were block randomized (block size 4) to either the FANS group or the T-UAS group. All patients underwent pre-stenting, real-time intrarenal pressure (IRP) monitoring via a pressure guidewire, and postoperative follow-up with CT scans on Day 1 and Day 30 to assess stone-free rates (SFR). Additional follow-up at 3 months was conducted to evaluate stone recurrence, ureteral strictures, and device-related complications. The primary outcomes assessed were operative time, intraoperative IRP, stone-free rates, and complication rates (Clavien-Dindo classification). Secondary outcomes included laser activation time, hemoglobin loss, hospital stay, and need for relook F-URS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged between 18 and 70 years undergoing flexible ureterorenoscopy (FURS) for unilateral renal calculi measuring between 10 and 20 millimeters were eligible.
- •Inclusion criteria included written informed consent for pre-stenting, postoperative stent removal after 30 days, and serial computed tomography (CT) evaluations on postoperative day 1 and day 30.
排除标准
- •Patients were excluded if they had a history of prior retrograde intrarenal surgery, active urinary tract infection, known coagulopathy, anatomical abnormalities of the urinary tract, history of urinary diversion, or if they required bilateral stone surgery or ureteral stone surgery.
结局指标
主要结局
Stone Free Rate, Operative Time, Intra Renal Pressure, Complication Rate.
时间窗: Pre-operative - 2 weeks before surgery, Intraoperative, Postoperative Day 1 and Day 30, Follow-up 3 months.
次要结局
- Laser Activation time, Hemoglobin loss, Hospital stay, Relook Flexible URS, Clavien Dindo grading of complications.(Pre-operative - 2 weeks before surgery, Intraoperative, Postoperative Day 1 and Day 30, Follow-up 3 months.)
研究者
Rajan Ravichandran
Sri Ramachandra Institute of Higher medical Education and Research