Multi-Center Comparison of Dual Lumen Versus Single Lumen Ureteroscopes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Time
研究概览
简要总结
Urolithiasis (kidney stones) is a common disease process affecting people all across the world. Usually, if the stone size is small, it is able to pass through the urinary system and exit the bladder on its own with no treatment. However, when the size of the stone is bigger, it can get trapped in the kidney or the ureter, causing significant pain for the patient and potentially obstructing urine flow. If this occurs, surgical treatment is necessary for the removal of the stone. The surgical procedure often employed involves the use of a ureteroscope, which is a device that includes a camera and channels for working instruments such as a grasper and laser fiber to be placed during a procedure. Ureteroscopes that are currently in use are flexible and have the ability to treat stones that may otherwise be inaccessible in the kidney. Most flexible ureteroscopes in clinical use currently only have one channel therefore only allowing one instrument to be used at a time. Recently, a new type of ureteroscope has been introduced in the market that offers the advantage of having two working channels where two instruments can be inserted for use during stone treating procedure. This can potentially decrease procedure time for patients affected by kidney stones.
The purpose of this research is to compare the efficacy and safety of the ureteroscopes that have only one channel for instrument insertion with the newer ureteroscope that has two channels for utilization during stone treatment.
详细描述
Study design
This study will be prospective, multi-institutional randomized controlled trial comparing single lumen and dual lumen ureteroscopes. Specifically, a new double-lumen ureteroscope will be compared in a multicenter trial with the currently existing single-lumen ureteroscopes in patients undergoing ureteroscopy for stones in the kidney and ureter.
Patient Recruitment and Randomization
All patients presenting to the Department of Urology at University of California, Irvine, University of Toronto and North Shore-LIJ Health System requiring a flexible ureteroscopy for treatment of their kidney or ureteral stone disease will be approached for enrolment in the study, assuming the inclusion and exclusion criteria detailed below are met. After discussion of the study with potential participants, interested parties will be given a copy of the consent form. The investigator will review and explain the consent form with the potential subject. All information about the study will be provided. Ample time will be given for individuals to ask questions regarding participation and to have questions answered prior to signing the consent form. If so desired, those interested will be given a copy of the consent form to take home so that they may have the opportunity to discuss participation further with family and/or advisors. If an individual chooses to enroll, the consent form will be signed before procedure begins. Once an individual joins the study and informed consent is obtained, the subject will receive a signed copy of the consent form. Individuals may chose not be enrolled in the study or may withdraw from the study at any time without repercussions to subsequent care.
Patients agreeing to participate in the study will be randomized on the day of surgery. Stratified block randomization will be utilized to balance the number of patients with different stone sizes (>1cm, <1cm), kidney, proximal and distal ureteral stones between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients >18 years old.
- •Patients with <2 cm total burden of renal or ureteral stones eligible for flexible ureteroscopic lithotripsy.
排除标准
- •Patients <18 years old.
- •Patients who are not able to give consent for study
- •Patients with active urinary tract infection
- •Pregnant women
- •Patients who have had ureteroscopy, SWL or PCNL for the same stone on the ipsilateral kidney
结局指标
主要结局
Time
时间窗: Day 1 (Day of procedure)
The primary outcome of the proposed study will be the procedure time in minutes measured from the start of the endoscopic access to the end of the procedure including complete fragmentation and stone fragment removal.
次要结局
- Complications(Days 1-30)
- Time(Days 1-30)
- Device efficacy(Procedure day)
研究者
Jaime Landman
Professor of Urology and Radiology
University of California, Irvine