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Completed

NCT Number: NCT07589153

Which Patinets Benefit More From Percutaneous Nephrolithotomy? A Location-Based Comparative Analysis of PCNL and RIRS for 1-2 cm Renal Stones

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

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Key information

Conditions

Kidney Calculi Nephrolithiasis Urolithiasis Renal Stone

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Nephrolithotomy (PCNL)

Device

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.

Retrograde Intrarenal Surgery (RIRS)

Device

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.

Primary outcomes

  1. Stone-Free Rate (SFR)

    Time frame: 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 outcomes

  1. Total Operative Duration

    Time frame: 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

  2. Change in Hemoglobin Levels

    Time frame: Within 24 hours postoperatively.

    The difference between preoperative and postoperative hemoglobin levels to assess blood loss.

  3. Postoperative Complications

    Time frame: From surgery up to 30 days postoperatively.

    The frequency and severity of complications classified according to the Clavien-Dindo classification system

  4. Length of Hospital Stay

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.