Outcomes and Cost-Effectiveness of 6.3French vs. 7.5French Mini-Flexible Ureteroscopy in the Treatment of Renal Stones: A Non-Inferiority, Prospective, Randomized, Single-Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Stone Free Rate
研究概览
简要总结
This prospective, randomized, single-blinded, non-inferiority clinical trial will compare the clinical outcomes and cost-effectiveness of two mini-flexible ureteroscopes (6.3Fr and 7.5Fr) used during flexible ureteroscopy for the treatment of renal stones. Adult patients with renal stones up to 15 mm who are scheduled to undergo flexible ureteroscopy will be randomly assigned to one of the two study groups. The primary objectives are to compare stone-free rates and the ability to achieve primary renal access without preoperative ureteral stenting. Secondary outcomes include operative time, fluoroscopy use, ureteral trauma, postoperative stenting, pain, complications, emergency department visits, need for additional procedures, hospital stay, and cost-effectiveness. The results of this study are expected to provide high-quality evidence to guide the selection of mini-flexible ureteroscopes and improve the quality, safety, and value of surgical care for patients with kidney stones.
详细描述
Renal stone disease is a common condition with an increasing global incidence. Flexible ureteroscopy has become one of the standard treatments for renal stones because it provides excellent stone clearance with a minimally invasive approach. Recent technological advances have led to the development of mini-flexible ureteroscopes with smaller diameters, which may facilitate easier access to the kidney while reducing ureteral trauma and the need for preoperative ureteral stenting.
Although both 6.3Fr and 7.5Fr mini-flexible ureteroscopes are currently available for clinical use, there is limited high-level evidence comparing their clinical performance and cost-effectiveness. This prospective, randomized, single-blinded, non-inferiority trial aims to compare these two ureteroscope sizes in adult patients undergoing flexible ureteroscopy for renal stones.
Eligible participants will be randomized in a 1:1 ratio to undergo flexible ureteroscopy using either a 6.3Fr or a 7.5Fr mini-flexible ureteroscope. All procedures will be performed using standardized surgical techniques by experienced endourologists.
The primary outcomes are stone-free rate at one month after surgery and successful primary renal access without preoperative ureteral stenting. Secondary outcomes include operative time, fluoroscopy utilization, intraoperative ureteral trauma, postoperative ureteral stenting, postoperative pain, complications classified using the Clavien-Dindo system, emergency department visits, hospital length of stay, need for secondary procedures, and cost-effectiveness from the hospital payer perspective.
The investigators hypothesize that the 6.3Fr mini-flexible ureteroscope will improve primary renal access while reducing ureteral trauma, fluoroscopy exposure, postoperative stenting, and overall healthcare costs without compromising stone-free rates. The findings of this study may help establish evidence-based recommendations for selecting mini-flexible ureteroscopes and optimize the surgical management of patients with renal stone disease.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors, including staff collecting postoperative outcomes and radiologists evaluating imaging studies, will be blinded to treatment allocation. Operating surgeons and operating room personnel will not be blinded because they must know which ureteroscope is being used during the procedure
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 18 years or older.
- •Scheduled to undergo flexible ureteroscopy for renal stones.
- •Renal stone size ≤15 mm in the greatest dimension.
- •No indwelling ureteral stent at the time of surgery.
- •Able and willing to provide written informed consent.
排除标准
- •* Active urinary tract infection.
- •Anatomical abnormalities of the urinary tract (e.g., ureteral stricture, horseshoe kidney, ectopic kidney).
- •Solitary kidney.
- •Pregnancy.
- •Stones located within a calyceal diverticulum.
- •Any condition that, in the opinion of the investigator, would interfere with study participation or follow-up.
研究组 & 干预措施
6.3Fr Mini-Flexible Ureteroscope
Participants randomized to this arm will undergo flexible ureteroscopy using a 6.3Fr mini-flexible ureteroscope for the treatment of renal stones according to the study protocol
干预措施: 6.3Fr Mini-Flexible Ureteroscope (Device)
7.5Fr Mini-Flexible Ureteroscope
Participants randomized to this arm will undergo flexible ureteroscopy using a 7.5Fr mini-flexible ureteroscope for the treatment of renal stones according to the study protocol
干预措施: 7.5Fr Mini-Flexible Ureteroscope (Device)
结局指标
主要结局
Stone Free Rate
时间窗: 1 month after surgery
Stone-free status defined as the absence of residual stone fragments greater than 2 mm on non-contrast CT KUB
Primary Renal Access Success Rate
时间窗: Perioperative/Periprocedural
Successful passage of the flexible ureteroscope into the renal collecting system without the need for preoperative ureteral stenting
次要结局
- Operative Time(During surgery)
- Intraoperative Fluoroscopy Use(During surgery)
- Intraoperative Ureteral Trauma as Assessed by the Traxer Ureteral Injury Scale(Perioperative/Periprocedural)
- Postoperative Ureteral Stenting Rate(Immediately after surgery)
- Postoperative Pain as Assessed by the Visual Analog Scale(6, 24, and 48 hours after surgery)
- Postoperative Complications(Up to 30 days after surgery)
- Emergency Department Visits(Within 2 weeks after surgery)
- Hospital Length of Stay(Perioperative/Periprocedural period (from admission to discharge))
- Need for Secondary Procedures(Up to 1 month after surgery)
- Incremental Cost-Effectiveness Ratio Comparing 6.3Fr and 7.5Fr Mini-Flexible Ureteroscopes(From surgery through 30 days after surgery)
- Hospital Length of Stay(Perioperative/Periprocedural)