The authors hypothesize that the RIRS using 150-microm Tm-fiber laser is superior than fiber with larger diameters, as 200-microm Tm-fiber laser or 200-microm holmium fiber laser, in such points as follows: * decreasing surgery time and laser-on time due to possibility of 4.3 fold ablation efficacy increase, which has been shown by Andreeva et al.; * increasing the flexible ureteroscope tip deflection lower pole stones availability; * decreased risk of complications and a better irrigation and visualization due to better irrigation with smaller fiber; * increasing of lithotripsy efficacy and laser beam density by lowering of beam focal spot due to using of lesser fiber diameter
RIRS will be performed with SP TFL or Ho:YAG (100 W). The procedure is performed under general anesthesia with the patient in the dorsal lithotomy position. The bladder is entered either with a cystoscope or a semi-rigid ureterorenoscope. Guidewires (0.035") will be used to facilitate access (under fluoroscopic guidance). After access sheath (12/14) will be placed up to the kidney pelvis. Through the access sheath ureteroscope will be introduced. For nephrolithotripsy 145 mcm and 200 mcm fibers will be used. Large fragments could be extracted with nitinol basket. After the surgery ureteral stent (7 Fr.) will be placed inside the ureter for 10 to 14 days. A 10 Fr urethral catheter can be placed in the bladder for the drainage of the bladder during the operation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
retrograde intrarenal surgery
retrograde intrarenal surgery
retrograde intrarenal surgery
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, Russia
RECRUITINGLaser-on time
Time of laser emission during surgery, seconds
Time frame: during surgery
adverse events
Complications according to Clavien-Dindo classification (higher score means more severe complication)
Time frame: during surgery and 6 months after surgery
Operative time
Surgery duration, minutes
Time frame: during surgery
Hemoglobin drop
Change of hemoglobin level 1 day after surgery comparing to pre-operative value, g/L
Time frame: 1 day after surgery
Catheter stay
duration of catheterisation, days
Time frame: 1 week
hospitalization length
Duration of hospital stay after surgery, days
Time frame: 1 week
Radiation exposure
Duration of X-ray exposure, sec.
Time frame: during surgery
Radiation exposure
Effective dose, mSv
Time frame: during surgery
Stone-free rate
Percentage of patients with absence of stones larger 3 mm in maximum size on follow-up CT
Time frame: 3 month
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