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

10. maj 2026 opdateret af: Esra DOĞAN YILMAZ, PhD, Kırıkkale University
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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

110

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PCNL Group
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.
Enhed: 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.
Aktiv komparator: RIRS Group
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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stone-Free Rate (SFR)
Tidsramme: 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)
3 months postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Operative Duration
Tidsramme: 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
During the surgical procedure (intraoperative)
Change in Hemoglobin Levels
Tidsramme: Within 24 hours postoperatively.
The difference between preoperative and postoperative hemoglobin levels to assess blood loss.
Within 24 hours postoperatively.
Postoperative Complications
Tidsramme: From surgery up to 30 days postoperatively.
The frequency and severity of complications classified according to the Clavien-Dindo classification system
From surgery up to 30 days postoperatively.
Length of Hospital Stay
Tidsramme: 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.
From the day of surgery until hospital discharge (typically 1-3 days).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kırıkkale University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2012

Primær færdiggørelse (Faktiske)

15. september 2013

Studieafslutning (Faktiske)

1. november 2013

Datoer for studieregistrering

Først indsendt

10. maj 2026

Først indsendt, der opfyldte QC-kriterier

10. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12/14-06

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