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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP TFL RIRS with 145 mcm fiber | Experimental | Superpulse thulium fiber laser RIRS with 145 mcm laser fiber |
|
| SP TFL RIRS with 200 mcm fiber | Experimental | Superpulse thulium fiber laser RIRS with 200 mcm laser fiber |
|
| Ho:YAG RIRS with 200 mcm fiber | Active Comparator | Ho:YAG laser RIRS with 200 mcm laser fiber |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP TFL RIRS with 145 mcm fiber | Procedure | retrograde intrarenal surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Laser-on time | Time of laser emission during surgery, seconds | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | Complications according to Clavien-Dindo classification (higher score means more severe complication) | during surgery and 6 months after surgery |
| Operative time | Surgery duration, minutes |
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Inclusion Criteria:
Exclusion Criteria:
• Multiple (more than 3) kidney stones > 5 mm
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Urology and Reproductive Health, Sechenov University. | Recruiting | Moscow | 119991 | Russia |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| SP TFL RIRS with 200 mcm fiber |
| Procedure |
retrograde intrarenal surgery |
|
| Ho:YAG RIRS with 200 mcm fiber | Procedure | retrograde intrarenal surgery |
|
| during surgery |
| Hemoglobin drop | Change of hemoglobin level 1 day after surgery comparing to pre-operative value, g/L | 1 day after surgery |
| Catheter stay | duration of catheterisation, days | 1 week |
| hospitalization length | Duration of hospital stay after surgery, days | 1 week |
| Radiation exposure | Duration of X-ray exposure, sec. | during surgery |
| Radiation exposure | Effective dose, mSv | during surgery |
| Stone-free rate | Percentage of patients with absence of stones larger 3 mm in maximum size on follow-up CT | 3 month |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |