Study Results
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Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-10-08
2021-09-30
Brief Summary
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Detailed Description
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A total of 60 (sixty) patients, aging between 18 and 65 years, with similar stone size and location are being planned to be enrolled into the study; and will be prospectively randomized into two groups with a 1:1 ratio, thus 30 (thirty) patients will receive ultra-mini PCNL while 30 (thirty) patients will undergo micro PCNL.
Preoperatively, blood and urine Cystatin C levels will be measured. After the surgery, blood and urine Cystatin C levels at postoperative 12th hour will be recorded. Besides these, classical kidney function tests, namely blood urea and creatinine levels, will be measured preoperatively and postoperatively.
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 extracorporeal shock wave lithotripsy (ESWL)/PCNL/ureterorenoscopy (URS)/retrograde intrarenal surgery (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 period
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ultra-mini PCNL
Endoscopic kidney stone surgery: Patients will undergo ultra-mini percutaneous nephrolithotripsy.
Endoscopic kidney stone surgery
Ultra-mini PCNL will be performed.
Micro PCNL
Endoscopic kidney stone surgery: Patients will undergo micro percutaneous nephrolithotripsy.
Endoscopic kidney stone surgery
Micro PCNL will be performed.
Interventions
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Endoscopic kidney stone surgery
Ultra-mini PCNL will be performed.
Endoscopic kidney stone surgery
Micro PCNL will be performed.
Eligibility Criteria
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Inclusion Criteria
* Patients with a kidney stone \< 2 cm
* Patients between 18 and 65 years old
Exclusion Criteria
* Patients with a blood pressure higher than 140/80 mmHg despite use of antihypertensive drug(s) regularly
* Patients with chronic renal failure who need dialysis
* Patients who had prerenal, renal or postrenal acute kidney failure during the last 6 months
* Patients who had acute pyelonephritis during the last 6 months
* Patients younger than 18 years old or older than 65 years old
* Patients who had kidney surgery during the last 3 months and who have abnormal kidney functions
* Patients with ureteral stone who are planned to undergo endoscopic stone treatment at the same time
* Patients with a history of corticosteroid use during enrollment into the study or previous 3 months
* Patients with uncontrolled thyroid disease
* Patients who have a disease with rapid cell turn-over (like leukemia, lymphoma, etc.)
* Patients whose operation terminated or converted to open surgery due to any reason
* Patients with missing data
18 Years
65 Years
ALL
No
Sponsors
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The Scientific and Technological Research Council of Turkey
OTHER
Selcuk University
OTHER
Responsible Party
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Ozcan Kilic
M.D., Assoc. Prof. Dr.
Principal Investigators
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Ozcan Kilic, M.D.
Role: PRINCIPAL_INVESTIGATOR
Selcuk University, School of Medicine, Department of Urology
Locations
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Selcuk University, School of Medicine, Department of Urology
Konya, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Xu S, Shi H, Zhu J, Wang Y, Cao Y, Li K, Wang Y, Sun Z, Xia S. A prospective comparative study of haemodynamic, electrolyte, and metabolic changes during percutaneous nephrolithotomy and minimally invasive percutaneous nephrolithotomy. World J Urol. 2014 Oct;32(5):1275-80. doi: 10.1007/s00345-013-1204-2. Epub 2013 Nov 1.
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.
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.
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.
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.
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.
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.
Karatag T, Tepeler A, Buldu I, Akcay M, Tosun M, Istanbulluoglu MO, Armagan A. Is micro-percutaneous nephrolithotomy surgery technically feasible and efficient under spinal anesthesia? Urolithiasis. 2015 Jun;43(3):249-54. doi: 10.1007/s00240-015-0752-x. Epub 2015 Jan 9.
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.
Shlipak MG, Mattes MD, Peralta CA. Update on cystatin C: incorporation into clinical practice. Am J Kidney Dis. 2013 Sep;62(3):595-603. doi: 10.1053/j.ajkd.2013.03.027. Epub 2013 May 20.
Delanaye P, Cavalier E, Morel J, Mehdi M, Maillard N, Claisse G, Lambermont B, Dubois BE, Damas P, Krzesinski JM, Lautrette A, Mariat C. Detection of decreased glomerular filtration rate in intensive care units: serum cystatin C versus serum creatinine. BMC Nephrol. 2014 Jan 13;15:9. doi: 10.1186/1471-2369-15-9.
Krawczeski CD, Vandevoorde RG, Kathman T, Bennett MR, Woo JG, Wang Y, Griffiths RE, Devarajan P. Serum cystatin C is an early predictive biomarker of acute kidney injury after pediatric cardiopulmonary bypass. Clin J Am Soc Nephrol. 2010 Sep;5(9):1552-7. doi: 10.2215/CJN.02040310. Epub 2010 Jun 10.
Other Identifiers
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SU-PCNL-UMMP-02
Identifier Type: -
Identifier Source: org_study_id
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