Kidney Calculi Nephrolithiasis Urolithiasis Renal Stone
Conditions
Keywords
Kidney Calculi Nephrolithiasis Urolithiasis Renal Stone
Brief summary
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
Detailed description
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.
Interventions
DEVICEPercutaneous Nephrolithotomy (PCNL)
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.
Sponsors
Kırıkkale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients aged 18 years or older. Presence of a single, non-staghorn radiopaque renal stone measuring 10-20 mm in diameter. Stone location in the upper, middle, or lower renal calyx. Patients who provided written informed consent.
Exclusion criteria
Patients with untreated urinary tract infections or urosepsis. Patients with uncorrected bleeding disorders or receiving anticoagulant therapy. Presence of severe skeletal deformities preventing surgical positioning. Patients with morbid obesity (BMI \> 40 kg/m²). Presence of anatomical abnormalities (e.g., horseshoe kidney, ectopic kidney). Pregnancy. Multiple renal stones or stones larger than 20 mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-Free Rate (SFR) | 3 months postoperatively | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Operative Duration | During the surgical procedure (intraoperative) | The time from the initial incision or insertion of the endoscope until the completion of the procedure and dressing, measured in minutes |
| Change in Hemoglobin Levels | Within 24 hours postoperatively. | The difference between preoperative and postoperative hemoglobin levels to assess blood loss. |
| Postoperative Complications | From surgery up to 30 days postoperatively. | The frequency and severity of complications classified according to the Clavien-Dindo classification system |
| Length of Hospital Stay | From the day of surgery until hospital discharge (typically 1-3 days). | The total number of days the patient remained in the hospital following the procedure. |
Outcome results
None listed