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Due to surgeons' unwillingness to randomize patients into different treatments
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| Name | Class |
|---|---|
| The Scientific and Technological Research Council of Turkey | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional PCNL | Active Comparator | Endoscopic kidney stone surgery: Patients will undergo conventional percutaneous nephrolithotripsy. |
|
| Mini PCNL | Active Comparator | Endoscopic kidney stone surgery: Patients will undergo mini percutaneous nephrolithotripsy. |
|
| Ultra-mini PCNL | Active Comparator | Endoscopic kidney stone surgery: Patients will undergo ultra-mini percutaneous nephrolithotripsy. |
|
| Micro PCNL | Active Comparator | Endoscopic kidney stone surgery: Patients will undergo micro percutaneous nephrolithotripsy. |
|
| Retrograde intrarenal surgery | Active Comparator | Endoscopic kidney stone surgery: Patients will undergo retrograde intrarenal surgery. |
|
| Extracorporeal shock wave lithotripsy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic kidney stone surgery | Procedure | Conventional PCNL will be performed. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-free rate | Determination of any residual stone in the collecting system by using one of imaging modalities. | Within the first 30 days after surgery/procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Determination of any complications related to the surgery/procedure. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murat Akand, M.D. | Selcuk University, School of Medicine, Department of Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Selcuk University, School of Medicine, Department of Urology | Konya | 42075 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25454613 | Background | Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrik A, Turk C. Metabolic evaluation and recurrence prevention for urinary stone patients: EAU guidelines. Eur Urol. 2015 Apr;67(4):750-63. doi: 10.1016/j.eururo.2014.10.029. Epub 2014 Nov 20. | |
| 21247286 | Background | de la Rosette J, Assimos D, Desai M, Gutierrez J, Lingeman J, Scarpa R, Tefekli A; CROES PCNL Study Group. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: indications, complications, and outcomes in 5803 patients. J Endourol. 2011 Jan;25(1):11-7. doi: 10.1089/end.2010.0424. |
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| Active Comparator |
Non-invasive kidney stone treatment: Patients will undergo extracorporeal shock wave lithotripsy. |
|
| Endoscopic kidney stone surgery |
| Procedure |
Mini PCNL will be performed. |
|
| Endoscopic kidney stone surgery | Procedure | Ultra-mini PCNL will be performed. |
|
| Endoscopic kidney stone surgery | Procedure | Micro PCNL will be performed. |
|
| Endoscopic kidney stone surgery | Procedure | Retrograde intrarenal surgery will be performed. |
|
| Non-invasive kidney stone treatment | Procedure | Extracorporeal shock wave will be performed. |
|
| 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. | 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. | 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. | 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. | Within the first 24 hours after surgery/procedure |
| 25100624 | Background | Kamphuis GM, Baard J, Westendarp M, de la Rosette JJ. Lessons learned from the CROES percutaneous nephrolithotomy global study. World J Urol. 2015 Feb;33(2):223-33. doi: 10.1007/s00345-014-1367-5. Epub 2014 Aug 7. |
| 21477921 | Background | Bader MJ, Gratzke C, Seitz M, Sharma R, Stief CG, Desai M. The "all-seeing needle": initial results of an optical puncture system confirming access in percutaneous nephrolithotomy. Eur Urol. 2011 Jun;59(6):1054-9. doi: 10.1016/j.eururo.2011.03.026. Epub 2011 Apr 1. |
| 21575966 | Background | Desai MR, Sharma R, Mishra S, Sabnis RB, Stief C, Bader M. Single-step percutaneous nephrolithotomy (microperc): the initial clinical report. J Urol. 2011 Jul;186(1):140-5. doi: 10.1016/j.juro.2011.03.029. Epub 2011 May 14. |
| 24337646 | Background | Hatipoglu NK, Tepeler A, Buldu I, Atis G, Bodakci MN, Sancaktutar AA, Silay MS, Daggulli M, Istanbulluoglu MO, Karatag T, Gurbuz C, Armagan A, Caskurlu T. Initial experience of micro-percutaneous nephrolithotomy in the treatment of renal calculi in 140 renal units. Urolithiasis. 2014 Apr;42(2):159-64. doi: 10.1007/s00240-013-0631-2. Epub 2013 Dec 13. |
| 23841665 | Background | Desai J, Solanki R. Ultra-mini percutaneous nephrolithotomy (UMP): one more armamentarium. BJU Int. 2013 Nov;112(7):1046-9. doi: 10.1111/bju.12193. Epub 2013 Jul 11. |
| 22840867 | Background | Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the "resorlu-unsal stone score". Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26. |
| 24881777 | Background | Cepeda M, Amon JH, Mainez JA, Rodriguez V, Alonso D, Martinez-Sagarra JM. Flexible ureteroscopy for renal stones. Actas Urol Esp. 2014 Nov;38(9):571-5. doi: 10.1016/j.acuro.2014.03.014. Epub 2014 Jun 2. English, Spanish. |
| 24892920 | Background | Gao X, Peng Y, Shi X, Li L, Zhou T, Xu B, Sun Y. Safety and efficacy of retrograde intrarenal surgery for renal stones in patients with a solitary kidney: a single-center experience. J Endourol. 2014 Nov;28(11):1290-4. doi: 10.1089/end.2014.0295. Epub 2014 Aug 6. |
| 24892394 | Background | Palmero JL, Miralles J, Garau C, Nuno de la Rosa I, Amoros A, Benedicto A. Retrograde intrarenal surgery (RIRS) in the treatment of calyceal diverticulum with lithiasis. Arch Esp Urol. 2014 May;67(4):331-6. English, Spanish. |
| 22642568 | Background | Aboumarzouk OM, Monga M, Kata SG, Traxer O, Somani BK. Flexible ureteroscopy and laser lithotripsy for stones >2 cm: a systematic review and meta-analysis. J Endourol. 2012 Oct;26(10):1257-63. doi: 10.1089/end.2012.0217. Epub 2012 Jul 30. |
| 23958507 | Result | Wong KA, Sahai A, Patel A, Thomas K, Bultitude M, Glass J. Is percutaneous nephrolithotomy in solitary kidneys safe? Urology. 2013 Nov;82(5):1013-6. doi: 10.1016/j.urology.2013.06.034. Epub 2013 Aug 16. |
| 25064687 | Result | De S, Autorino R, Kim FJ, Zargar H, Laydner H, Balsamo R, Torricelli FC, Di Palma C, Molina WR, Monga M, De Sio M. Percutaneous nephrolithotomy versus retrograde intrarenal surgery: a systematic review and meta-analysis. Eur Urol. 2015 Jan;67(1):125-137. doi: 10.1016/j.eururo.2014.07.003. Epub 2014 Jul 23. |
| 24162954 | Result | Bas O, Bakirtas H, Sener NC, Ozturk U, Tuygun C, Goktug HN, Imamoglu MA. Comparison of shock wave lithotripsy, flexible ureterorenoscopy and percutaneous nephrolithotripsy on moderate size renal pelvis stones. Urolithiasis. 2014 Apr;42(2):115-20. doi: 10.1007/s00240-013-0615-2. Epub 2013 Oct 27. |
| 23179732 | Result | Resorlu B, Unsal A, Ziypak T, Diri A, Atis G, Guven S, Sancaktutar AA, Tepeler A, Bozkurt OF, Oztuna D. Comparison of retrograde intrarenal surgery, shockwave lithotripsy, and percutaneous nephrolithotomy for treatment of medium-sized radiolucent renal stones. World J Urol. 2013 Dec;31(6):1581-6. doi: 10.1007/s00345-012-0991-1. Epub 2012 Nov 22. |
| 23816573 | Result | Ozturk U, Sener NC, Goktug HN, Nalbant I, Gucuk A, Imamoglu MA. Comparison of percutaneous nephrolithotomy, shock wave lithotripsy, and retrograde intrarenal surgery for lower pole renal calculi 10-20 mm. Urol Int. 2013;91(3):345-9. doi: 10.1159/000351136. Epub 2013 Jun 28. |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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