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

NCT07589153 | Completed

• 1 other identifier: 12/14-06
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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

Conditions

Kidney Calculi Nephrolithiasis Urolithiasis Renal Stone

Keywords

Kidney Calculi Nephrolithiasis Urolithiasis Renal Stone

Outcome Measures

Primary Outcomes (1)

• 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)

  3 months postoperatively

Secondary Outcomes (4)

• Total Operative Duration

  During the surgical procedure (intraoperative)

• Change in Hemoglobin Levels

  Within 24 hours postoperatively.

• Postoperative Complications

  From surgery up to 30 days postoperatively.

• Length of Hospital Stay

  From the day of surgery until hospital discharge (typically 1-3 days).

Study Arms (2)

PCNL Group

EXPERIMENTAL

Patients in this group underwent Percutaneous Nephrolithotomy (PCNL) for the treatment of renal stones measuring 10-20 mm. The procedure was performed in the prone or lithotomy position under general anesthesia.

Device: Percutaneous Nephrolithotomy (PCNL)

RIRS Group

ACTIVE COMPARATOR

Patients in this group underwent Retrograde Intrarenal Surgery (RIRS) using a flexible ureterorenoscope and laser lithotripsy for the treatment of renal stones measuring 10-20 mm.

Device: Retrograde Intrarenal Surgery (RIRS)

Interventions

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.

PCNL Group

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.

RIRS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırıkkale University: lead

MeSH Terms

Interventions

Nephrolithotomy, Percutaneous

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Faculty of Health Sciences, Department of Nursing

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 15, 2026
• Study Start: May 1, 2012
• Primary Completion: September 15, 2013
• Study Completion: November 1, 2013
• Last Updated: May 15, 2026

Record last verified: 2026-05