Kidney Calculi Nephrolithiasis Urolithiasis Renal StoneNCT07589153
Which Patinets Benefit More From Percutaneous Nephrolithotomy? A Location-Based Comparative Analysis of PCNL and RIRS for 1-2 cm Renal Stones
A study testing Percutaneous Nephrolithotomy (PCNL) and Retrograde Intrarenal Surgery (RIRS) in people with Kidney Calculi Nephrolithiasis Urolithiasis Renal Stone, run by Kırıkkale University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Calculi Nephrolithiasis Urolithiasis Renal Stone
- What is being tested?
- Percutaneous Nephrolithotomy (PCNL) and Retrograde Intrarenal Surgery (RIRS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2012to 1 Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
Read the 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.
- Being tested
- Percutaneous Nephrolithotomy (PCNL), Retrograde Intrarenal Surgery (RIRS)
- Keywords
- Kidney Calculi Nephrolithiasis Urolithiasis Renal Stone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Retrograde Intrarenal Surgery (RIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months postoperatively
Secondary outcomes (4)
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
Measured: During the surgical procedure (intraoperative)
Change in Hemoglobin Levels
The difference between preoperative and postoperative hemoglobin levels to assess blood loss.
Measured: Within 24 hours postoperatively.
Postoperative Complications
The frequency and severity of complications classified according to the Clavien-Dindo classification system
Measured: 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.
Measured: From the day of surgery until hospital discharge (typically 1-3 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 May 2012
- Primary completion15 Sep 2013
- Study completion1 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Calculi Nephrolithiasis Urolithiasis Renal StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra DOĞAN YILMAZ, PhD, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589153
- Sponsor's protocol ID
- 12/14-06
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Patinets Benefit More From Percutaneous Nephrolithotomy? A Location-Based Comparative Analysis of PCNL and RIRS for 1-2 cm Renal Stones
- ClinicalTrials.gov ID
- NCT07589153
- Acronym / sponsor ID
- 12/14-06
- Keywords
- Kidney Calculi Nephrolithiasis Urolithiasis Renal Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 15 Sep 2013 (actual)
- Study completion
- 1 Nov 2013 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCNL Group | Experimental | Device: Percutaneous Nephrolithotomy (PCNL)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. |
| RIRS Group | Active comparator | Device: Retrograde Intrarenal Surgery (RIRS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous 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. | Device | PCNL Group |
| Retrograde Intrarenal Surgery (RIRS)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. | Device | RIRS Group |
Primary outcome
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)
4 secondary outcomes
Total Operative Duration
Time frame: During the surgical procedure (intraoperative)
Change in Hemoglobin Levels
Time frame: Within 24 hours postoperatively.
Postoperative Complications
Time frame: From surgery up to 30 days postoperatively.
Length of Hospital Stay
Time frame: From the day of surgery until hospital discharge (typically 1-3 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Nephrolithotomy (PCNL) and Retrograde Intrarenal Surgery (RIRS) in people with Kidney Calculi Nephrolithiasis Urolithiasis Renal Stone, run by Kırıkkale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-Free Rate (SFR) (time frame: 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.