The investigators plan to compare three different devices that are used to break up large kidney stones during surgery for removal to see if one is faster or more efficient than the others.
Large kidney stones can be removed by a surgical procedure where a small puncture is made through the back into the kidney (percutaneous nephrolithotomy or PNL) but the stones usually need to be broken into smaller pieces before they can be removed through the small surgical incision. There are a number of FDA approved devices commercially available used to break up the stones including pneumatic, ultrasonic, and a combination of the two. Each technology has advantages and disadvantages. In the last few years there have been new, improved versions of these devices introduced. These improved versions have addressed previous issues of probes clogging or breaking and cumbersome handpiece design. These include the Cyberwand (Cybersonics, Erie, PA), a dual probe ultrasonic device, Swiss Lithoclast Select (EMS, Switzerland) combining the pneumatic and ultrasonic modalities, and a novel device by LMA (Gland, Switzerland) called the StoneBreakerTM, a portable pneumatic device powered by CO2 cartridges. We propose to compare each of these devices in a randomized study to see if one is better than another at removing kidney stones quickly and efficiently.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
270
Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.
Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented
Mayo Clinic Scottsdale
Phoenix, Arizona, United States
Northwestern University
Chicago, Illinois, United States
IU Health Physicians Urology
Indianapolis, Indiana, United States
Stone Clearance Time in mm2/Min
Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)
Time frame: collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket
Stone-free After First Procedure
Number of participants deemed stone-free after initial stone-removal surgery
Time frame: Post-operative Day 1
Secondary Procedure Required
Number of participants who required a secondary kidney stone removal procedure
Time frame: Within three days of initial procedure
Ureteral Stent Placed
Participants requiring a ureteral stent to be placed after initial stone removal procedure
Time frame: Intra-operatively
Nephrostomy Tube Placed
Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure
Time frame: Intra-operatively
Use of Other Device
Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite
Time frame: Intra-operatively
EBL>400mL
Number of participants with an estimated blood loss greater than 400mL
Time frame: Intra-operatively
RBC Transfusion
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Johns Hopkins
Baltimore, Maryland, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Duke University
Durham, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Wisconsin
Madison, Wisconsin, United States
University of British Columbia
Vancouver, British Columbia, Canada
The University of Western Ontario
London, Ontario, Canada
Number of participants who required a blood transfusion post-operatively
Time frame: Post-operatively <24 hours
Length of Stay
Number of days participants were in hospital. Operative day is Day 1.
Time frame: Post-operatively
Post-operative Complications
Number of participants who experienced surgery-related post-op complications
Time frame: Post-operative Days 2 and 3