Which Patinets Benefit More From Percutaneous Nephrolithotomy? A Location-Based Comparative Analysis of PCNL and RIRS for 1-2 cm Renal Stones
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Stone-Free Rate (SFR)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Total Operative Duration
Lasso di tempo: 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
Lasso di tempo: Within 24 hours postoperatively.
|
The difference between preoperative and postoperative hemoglobin levels to assess blood loss.
|
Within 24 hours postoperatively.
|
|
Postoperative Complications
Lasso di tempo: 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
Lasso di tempo: 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).
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 12/14-06
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Percutaneous Nephrolithotomy (PCNL)
-
The First Affiliated Hospital of Guangzhou Medical...Non ancora reclutamento
-
Mahidol UniversityNon ancora reclutamentoProblemi di sicurezza | Chirurgia-complicanze | Nefrolitiasi Calcolo di StaghornTailandia
-
The First Affiliated Hospital of Guangzhou Medical...Massachusetts General Hospital; University College London Hospitals; University... e altri collaboratoriSconosciutoChirurgia | Pietra, Rene | Litiasi renale
-
Foundation EndourologyThe International Alliance of UrolithiasisReclutamento
-
Assiut UniversityNon ancora reclutamentoCalcoli di Staghorn
-
The Cleveland ClinicMassachusetts General Hospital; University of British Columbia; Columbia University e altri collaboratoriCompletatoMalattie renali | Calcoli renali | Urolitiasi | Calcoli ureterali | Calcolo renaleStati Uniti
-
Assiut UniversityAttivo, non reclutante
-
Mansoura UniversitySconosciutoComplicanza della procedura chirurgica | Posizione prona | Nefrolitotomia percutanea (PCNL) | Posizione prona-flessaEgitto
-
Tianjin Medical University Second HospitalThe First Affiliated Hospital with Nanjing Medical University; Peking University... e altri collaboratoriNon ancora reclutamento