Kidney Stones Clinical Trial
Official title:
Comparison of Success Rates, Complication Rates and Injury to Kidneys of Conventional PCNL, Mini PCNL, Ultra-mini PCNL, Micro PCNL, RIRS and ESWL in the Treatment of Lower Pole and Renal Pelvis Stone(s)
It is aimed to evaluate the treatment results, rates of success and complications, and injury given to the kidney by measuring preoperative and postoperative blood urea, creatinine, Cystatin C and Netrin-1 levels and urine Cystatin C and Netrin-1 levels in patients with lower pole or renal pelvis stone(s) undergoing either one of the treatment modalities including conventional percutaneous nephrolithotripsy (PCNL), mini PCNL, ultra-mini PCNL, micro PCNL, retrograde intrarenal surgery (RIRS) and extracorporeal shock wave lithotripsy (ESWL).
In this study, the demographic and preoperative data, imaging data, operative data and
postoperative follow-up data will be prospectively recorded according to the patient
information forms for the patients with lower pole and/or renal pelvis stone(s) who will
undergo either one of the treatment modalities including conventional PCNL, mini PCNL,
ultra-mini PCNL, micro PCNL, RIRS and ESWL.
A total of 300 (three hundred) patients, aging between 18 and 70 years, with similar stone
size and location are being planned to be enrolled into the study; and will be prospectively
randomized into one of six groups with a 1:1 ratio. By this means, conventional PCNL will
performed to 50 (fifty) patients, mini PCNL will be performed to 50 (fifty) patients,
ultra-mini PCNL will be performed to 50 (fifty) patients, micro PCNL will be performed to 50
(fifty) patients, while 50 (fifty) patients will undergo RIRS and 50 (fifty) patients will
undergo ESWL.
Preoperatively, blood Cystatin C and Netrin-1, and urine Neutrophil gelatinase-associated
lipocalin (NGAL), Cystatin C and Netrin-1 levels will be measured. After the treatments,
blood Cystatin C and Netrin-1 levels at postoperative 6th, 12th, 24th and 48th hours will be
recorded. Cystatin C and Netrin-1 levels in urine will be measured at postoperative 12th and
24th hours, while urine NGAL levels will be measured at postoperative 12th and 72nd hours.
Besides these, classical kidney function tests, namely blood urea and creatinine levels, will
be measured preoperatively and postoperatively at 24th and 48th hours.
Parameters listed below will be also recorded and evaluated:
1. Preoperative general evaluation data: Age, height, weight, body-mass index, concomitant
comorbidities, prescriptions used, history of operation(s), American Society of
Anesthesiologists (ASA) score
2. Preoperative urological evaluation data: History of ESWL/PCNL/ureterorenoscopy
(URS)/RIRS/open surgery, whole blood count, kidney function tests, automatic urine test,
urine culture, preoperative imaging modality (KUB, US, CT),
number-dimensions-localization-composition of stone(s), existence of hydronephrosis
3. Operative data: Access fluoroscopy duration, total access duration, total fluoroscopy
duration, operation duration, use of double-J stent, preoperative complications
4. Number of previous ESWL seance, total duration of ESWL, number of shots during ESWL (if
any)
5. Follow-up data: Urethral catheterization time, hospitalization time, need of any other
treatment for being stone-free, time to full stone-free, duration to removal of double-J
stent, existence of residual stone(s), formation of new stone(s), complications in late
time, medical prophylaxis
6. Stone analysis
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