NCT04346485

Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers

Prospective Randomized Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers for the Management of Lower Pole Kidney Stones: Single-center Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: I.M. Sechenov First Moscow State Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Kidney Stone
• Nephrolithiasis
• Urolithiasis

Interventions

Type	Name	Description
PROCEDURE	SP TFL RIRS with 145 mcm fiber	retrograde intrarenal surgery
PROCEDURE	SP TFL RIRS with 200 mcm fiber	retrograde intrarenal surgery
PROCEDURE	Ho:YAG RIRS with 200 mcm fiber	retrograde intrarenal surgery

Timeline

• Start date: 2020-03-13
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2020-04-15
• Last updated: 2021-07-22

Locations

1 site across 1 country: Russia