An interventional study of Endoscopic kidney stone surgery and Endoscopic kidney stone surgery in Kidney Stones, sponsored by Selcuk University. Suspended at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by Selcuk University · Not applicable, Interventional, and Treatment
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:
597 studies on the registry are indexed under Kidney Calculi; 162 are open to participants now.
This study's planned enrollment of 300 is above the median of 90 across 460 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Selcuk University is the lead sponsor of 248 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Endoscopic kidney stone surgery: Patients will undergo conventional percutaneous nephrolithotripsy.
Procedure: Endoscopic kidney stone surgery
Endoscopic kidney stone surgery: Patients will undergo mini percutaneous nephrolithotripsy.
Procedure: Endoscopic kidney stone surgery
Endoscopic kidney stone surgery: Patients will undergo ultra-mini percutaneous nephrolithotripsy.
Procedure: Endoscopic kidney stone surgery
Endoscopic kidney stone surgery: Patients will undergo micro percutaneous nephrolithotripsy.
Procedure: Endoscopic kidney stone surgery
Endoscopic kidney stone surgery: Patients will undergo retrograde intrarenal surgery.
Procedure: Endoscopic kidney stone surgery
Non-invasive kidney stone treatment: Patients will undergo extracorporeal shock wave lithotripsy.
Procedure: Non-invasive kidney stone treatment
Conventional PCNL will be performed.
Mini PCNL will be performed.
Ultra-mini PCNL will be performed.
Micro PCNL will be performed.
Retrograde intrarenal surgery will be performed.
Extracorporeal shock wave will be performed.
Stone-free rate
Determination of any residual stone in the collecting system by using one of imaging modalities.
Time frame: Within the first 30 days after surgery/procedure
Complication rate
Determination of any complications related to the surgery/procedure.
Time frame: Within the first 30 days after surgery/procedure
Blood Cystatin C level (mg/L)
Determination of any impairment in renal function after the surgery/procedure by measuring blood Cystatin C level.
Time frame: Within the first 48 hours after surgery/procedure
Blood Netrin-1 level (pg/mL)
Determination of any impairment in renal function after the surgery/procedure by measuring blood Netrin-1 level.
Time frame: Within the first 48 hours after surgery/procedure
Urine NGAL level (ng/mL)
Determination of any impairment in renal function after the surgery/procedure by measuring urine NGAL level.
Time frame: Within the first 72 hours after surgery/procedure
Urine Cystatin C level (mg/L)
Determination of any impairment in renal function after the surgery/procedure by measuring urine Cystatin C level.
Time frame: Within the first 24 hours after surgery/procedure
Urine Netrin-1 level (pg/mL)
Determination of any impairment in renal function after the surgery/procedure by measuring urine Netrin-1 level.
Time frame: Within the first 24 hours after surgery/procedure
Plan to share: Undecided
This study is suspended, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Selcuk University