This prospective randomized controlled trial aims to compare the clinical efficacy and safety of Percutaneous Nephrolithotomy (PCNL) and Retrograde Intrarenal Surgery (RIRS) for renal stones measuring 10-20 mm. The study specifically investigates whether the anatomical location of the stone (upper, middle, or lower calyx) influences the success rates and stone-free outcomes of these two surgical modalities. A total of 110 patients were randomized into two equal groups to evaluate primary endpoints, including stone-free rates at the 3-month follow-up, and secondary endpoints such as operative time and complication rates
n this prospective randomized controlled trial, 110 adult patients diagnosed with a single non-staghorn renal stone measuring 10-20 mm were enrolled. The study was conducted at Kırıkkale High Specialization Hospital between the specified study dates. Participants were randomized in a 1:1 ratio into two treatment arms: Percutaneous Nephrolithotomy (PCNL) and Retrograde Intrarenal Surgery (RIRS). Randomization was implemented using a computer-generated sequence to ensure unbiased allocation. The primary objective is to compare the stone-free rates (SFR) between the two surgical techniques at the 3-month postoperative mark, as confirmed by non-contrast computed tomography. A secondary and key focus of the study is the impact of stone localization (upper, middle, and lower calyx) on the success of each procedure. Additional outcomes evaluated include total operative time, hospital stay duration, hemoglobin level changes, and postoperative complication rates according to the Clavien-Dindo classification system. The results aim to provide a location-based surgical selection framework for mid-sized renal stones.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
A standard percutaneous approach was used. Under general anesthesia, a nephrostomy tract was established, and the stone was fragmented using a pneumatic or ultrasonic lithotripter.
The procedure was performed using a flexible ureterorenoscope. Stones were fragmented using a Holmium:YAG laser fiber after reaching the renal pelvis and calyces retrogradely.
Stone-Free Rate (SFR)
The percentage of patients who are completely free of stones or have only clinically insignificant residual fragments (less than 3 mm). This will be evaluated using non-contrast computed tomography (NCCT)
Time frame: 3 months postoperatively
Total Operative Duration
The time from the initial incision or insertion of the endoscope until the completion of the procedure and dressing, measured in minutes
Time frame: During the surgical procedure (intraoperative)
Change in Hemoglobin Levels
The difference between preoperative and postoperative hemoglobin levels to assess blood loss.
Time frame: Within 24 hours postoperatively.
Postoperative Complications
The frequency and severity of complications classified according to the Clavien-Dindo classification system
Time frame: From surgery up to 30 days postoperatively.
Length of Hospital Stay
The total number of days the patient remained in the hospital following the procedure.
Time frame: From the day of surgery until hospital discharge (typically 1-3 days).
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