Clinical trial NCT03503539: Are the Stone Density and Location Useful Parameters for Small Kidney Stones?
Official title: Are the Stone Density and Location Useful Parameters That Can Determine the Endourological Surgical Technique for Kidney Stones That Are Smaller Than 2 cm? Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Calculi
Kidney Stone
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to evaluate whether these parameters could be guides for us in the selection of RIRS or Mini-PNL procedures in kidney stones that are smaller than 2 cm.

The patients that have kidney stones smaller than two cm and be planned to undergo surgery were randomized into 2 groups prospectively. RIRS was performed in the RIRS group using a 7.5-F fiberoptic flexible ureterorenoscope while Mini-PCNL group was dilated up to 16.5F and mini-PCNL was performed with 12F nephroscopy. Preoperative characteristics, operative and postoperative results were compared in two groups. Thereafter, intra and intergroup comparisons were made to determine the effects of HU value, indicating the stone density, higher or less than 677 and the stone location on stone-free rates.


Eligibility criteria: Inclusion Criteria:

* Patients were evaluated with non-contrast abdominopelvic CT after a detailed anamnesis and physical examination.
* Patients, who had a kidney stone with a maximum diameter of less than 2 cm and who did not prefer to undergo ESWL, were taken into the study.

Exclusion Criteria:

* Patients with anomalous kidneys, skeletal deformities, severe obesity (BMI\> 35) and those underwent ESWL treatment previously for the same stone were excluded from the study.

Primary outcomes:
measure: Stone free rate
timeFrame: 1 year
Secondary outcomes:
measure: Mean fluoroscopy time
timeFrame: İntraoperative duration of flouroscopy
Other outcomes:
Locations:
Study officials:
References:
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citation: Turk C, Petrik A, Sarica K, Seitz C, Skolarikos A, Straub M, Knoll T. EAU Guidelines on Diagnosis and Conservative Management of Urolithiasis. Eur Urol. 2016 Mar;69(3):468-74. doi: 10.1016/j.eururo.2015.07.040. Epub 2015 Aug 28.
citation: Gucuk A, Uyeturk U, Ozturk U, Kemahli E, Yildiz M, Metin A. Does the Hounsfield unit value determined by computed tomography predict the outcome of percutaneous nephrolithotomy? J Endourol. 2012 Jul;26(7):792-6. doi: 10.1089/end.2011.0518. Epub 2012 Feb 10.