An interventional study of SP TFL RIRS with 145 mcm fiber and SP TFL RIRS with 200 mcm fiber in Kidney Stone, Nephrolithiasis and Urolithiasis, sponsored by I.M. Sechenov First Moscow State Medical University. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-22.
Sponsored by I.M. Sechenov First Moscow State Medical University · Not applicable, Interventional, and Treatment
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:
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.
598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.
This study's planned enrollment of 105 is above the median of 90 across 461 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 133 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Superpulse thulium fiber laser RIRS with 145 mcm laser fiber
Procedure: SP TFL RIRS with 145 mcm fiber
Superpulse thulium fiber laser RIRS with 200 mcm laser fiber
Procedure: SP TFL RIRS with 200 mcm fiber
Ho:YAG laser RIRS with 200 mcm laser fiber
Procedure: Ho:YAG RIRS with 200 mcm fiber
retrograde intrarenal surgery
retrograde intrarenal surgery
retrograde intrarenal surgery
Laser-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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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I.M. Sechenov First Moscow State Medical University