Which Patinets Benefit More From Percutaneous Nephrolithotomy? A Location-Based Comparative Analysis of PCNL and RIRS for 1-2 cm Renal Stones
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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).
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 12/14-06
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