Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope
Condition: Kidney Calculi; Ureter Calculi
MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi
Study type: Interventional

Summary: 
      Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases
      including urinary stones. However, they require a long turnover time between procedures
      because of the sterilization process. Moreover, repeated use of a scope ultimately
      deteriorates its image quality which leads to a high maintenance cost in the long-term. A
      disposable digital flexible ureteroscope was released in the United States in January 2016,
      offering an improved image resolution, new scope performance characteristics with every case,
      and no need for sterilization and repair. Preliminary data from our center has demonstrated
      that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope
      and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment
      with disposable scopes may be more effective for patients and facilitate cost management
      within the hospital.

      Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes
      between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.
    

Detailed description: 
      This is a single center, prospective, randomized controlled pragmatic clinical trial designed
      to compare between disposable, reusable fiberoptic, and reusable digital ureteroscopes in
      upper urinary tract stone treatment efficacy. Three hundred subjects with kidney and/or
      ureteral stones are planned to recruit for the study. All subjects will be computer
      sequence-randomized into having their ureteroscopic treatment performed with a disposable
      (LithoVue™), reusable fiberoptic (URF-P6™), or reusable digital (URF-V2™) flexible
      ureteroscope. Patient's demographics, physical, laboratory, and image findings will be
      collected before surgery. These clinical data are already being collected as part of an
      ongoing registry study. Perioperative timing as well as operator's satisfaction and fatigue
      and need for a second ureteroscope during the case will be recorded during the treatment
      course. Other clinical data will be collected at days 7, 30, 90, 180 after surgery. The
      condition of the used ureteroscopes will be tracked and recorded to confirm the repair rate.

      Screening data will be reviewed to determine subject eligibility. Subjects who meet all
      inclusion criteria and none of the exclusion criteria will be entered into the study.

      The following surgical treatment will be used similarly for all three randomized arms and
      represents standard of case therapy:

      Ureteroscopic stone removal Under general anesthesia, the patient is placed in the lithotomy
      position. All procedures are performed under direct videoscopic and fluoroscopic guidance.
      Fluoroscopic screening is utilized using a mobile multidirectional C-arm fluoroscopy unit.
      Initially, a safety guide-wire is placed into the renal pelvis, followed by a ureteral access
      sheath as needed to maintain low intra-renal pressure and to facilitate the procedures. Using
      a flexible ureteroscope, renal or ureteral stones are identified and fragmented with a
      holmium YAG laser. Basket extraction of residual fragments is done until visual complete
      clearance of stone fragments is achieved.

      After ureteroscopy is done and stone clearance is achieved, a ureteral stent is placed at the
      end of the procedure to drain the kidney for 2-21 days if it is clinically indicated.

      The total duration of the study is expected to be one year for subject recruitment and one
      year and six months for final subject follow-up.
    

Intervention name(s): reusable fiberoptic ureteroscope; disposable digital ureteroscope
Intervention type(s): Device; Device
Intervention description(s): We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.; We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be assigned to each 3 type of ureteroscope and receive the flexible ureteroscopy. In each ureteroscopy, only one type of ureteroscope will be used; therefore this study will be parallel model.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ureteroscopy; flexible ureteroscope; randomized controlled trial