Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery
The Impact of Two Different Ureteral Access Sheaths on Success and Complications in Endoscopic Kidney Stone Surgery
This prospective, randomized, comparative study aims to evaluate the impact of aspirating and non-aspirating ureteral access sheaths on success rates and complications in patients undergoing retrograde intrarenal surgery (RIRS) for kidney stones. A total of 70 patients with renal stones smaller than 2 cm will be enrolled and randomly assigned to two groups. One group will undergo RIRS using a non-aspirating ureteral access sheath, while the other group will be treated using an aspirating ureteral access sheath.
The primary outcome of the study is the stone-free rate, which will be assessed at postoperative follow-up. Secondary outcomes include operative time, fluoroscopy time, length of hospital stay, postoperative complications according to the Clavien-Dindo classification, infection-related parameters, and the need for ureteral stenting.
The study aims to determine whether the use of an aspirating access sheath improves surgical outcomes by reducing intrarenal pressure, enhancing visualization, and decreasing complication rates. The findings are expected to contribute to optimizing device selection and improving clinical outcomes in endoscopic kidney stone surgery.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study is designed as a prospective, randomized, comparative clinical trial to evaluate the effectiveness and safety of aspirating versus non-aspirating ureteral access sheaths in patients undergoing retrograde intrarenal surgery (RIRS) for kidney stones.
Ureteral access sheaths are commonly used during RIRS to facilitate repeated access to the collecting system, maintain low intrarenal pressure, and improve visualization. While conventional non-aspirating sheaths allow passive outflow of irrigation fluid, aspirating sheaths provide active suction, which may enhance fragment evacuation, reduce intrarenal pressure, and potentially decrease infectious complications. However, comparative clinical data between these two approaches remain limited.
In this study, a total of 70 patients aged 18 to 75 years with renal stones smaller than 2 cm will be enrolled after providing informed consent. Patients will be randomized into two groups using a computer-generated block randomization method. The first group will undergo RIRS using a non-aspirating ureteral access sheath, while the second group will undergo RIRS using an aspirating ureteral access sheath. All procedures will be performed using a standardized surgical technique.
Demographic characteristics, stone-related parameters, and perioperative variables will be recorded. Postoperative follow-up will include clinical and radiological evaluation. Stone-free status will be assessed during postoperative follow-up. Complications will be classified according to the Clavien-Dindo classification. Additional parameters, including operative time, fluoroscopy time, length of hospital stay, infection-related laboratory findings, and the need for auxiliary procedures, will also be evaluated.
The aim of this study is to determine whether the use of an aspirating ureteral access sheath improves surgical efficiency and safety compared with a conventional sheath. The results are expected to provide evidence to guide clinical decision-making in endoscopic kidney stone surgery.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: AHMET TAŞCI
- Numero di telefono: +905531596690
- Email: ahmettasci400@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Patients aged between 18 and 75 years
- Patients diagnosed with kidney stones smaller than 2 cm
- Patients scheduled for retrograde intrarenal surgery (RIRS)
- Patients who provide written informed consent
Exclusion Criteria:
- Patients with active urinary tract infection
- Patients with coagulopathy
- Pregnant patients
- Patients unable to tolerate the lithotomy position
- Patients with incomplete clinical or laboratory data
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: Non-aspirating ureteral access sheath
Patients undergoing retrograde intrarenal surgery (RIRS) using a non-aspirating ureteral access sheath.
|
A conventional ureteral access sheath that allows passive outflow of irrigation fluid during RIRS.
|
|
Sperimentale: Aspirating ureteral access sheath
Patients undergoing retrograde intrarenal surgery (RIRS) using an aspirating ureteral access sheath.
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A ureteral access sheath with an active suction system that facilitates removal of irrigation fluid and stone fragments during RIRS.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Stone-free status
Lasso di tempo: At 3 weeks postoperatively
|
Stone-free status is defined as the absence of residual stones on low-dose non-contrast computed tomography or plain urinary system radiography at 3 weeks postoperatively.
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At 3 weeks postoperatively
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Operation time
Lasso di tempo: Measured during surgery, from incision to closure (intraoperative period)
|
Operative time is defined as the duration from the start of the operation to its completion.
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Measured during surgery, from incision to closure (intraoperative period)
|
|
Length of hospital stay
Lasso di tempo: From postoperative admission to hospital discharge, assessed up to 30 days
|
Length of hospital stay is defined as the time from postoperative hospital admission to hospital discharge, measured in days.
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From postoperative admission to hospital discharge, assessed up to 30 days
|
|
Intraoperative complications
Lasso di tempo: From start to completion of surgery (intraoperative period)
|
Intraoperative complications are defined as any adverse events occurring during the surgical procedure, including but not limited to bleeding, ureteral injury, or technical difficulties.
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From start to completion of surgery (intraoperative period)
|
|
Postoperative infectious complications
Lasso di tempo: From end of surgery to 7 days postoperatively
|
Postoperative infectious complications are defined as infection-related adverse events occurring after surgery, including fever, urinary tract infection, and sepsis.
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From end of surgery to 7 days postoperatively
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Gauhar V, Traxer O, Castellani D, Sietz C, Chew BH, Fong KY, Hamri SB, Gokce MI, Gadzhiev N, Galosi AB, Yuen SKK, El Hajj A, Ko R, Zawadzki M, Sridharan V, Lakmichi MA, Corrales M, Malkhasyan V, Ragoori D, Soebhali B, Tan K, Chai CA, Tursunkulov AN, Tanidir Y, Persaud S, Elshazly M, Kamal W, Tefik T, Shrestha A, Tiong HC, Somani BK. Could Use of a Flexible and Navigable Suction Ureteral Access Sheath Be a Potential Game-changer in Retrograde Intrarenal Surgery? Outcomes at 30 Days from a Large, Prospective, Multicenter, Real-world Study by the European Association of Urology Urolithiasis Section. Eur Urol Focus. 2024 Dec;10(6):975-982. doi: 10.1016/j.euf.2024.05.010. Epub 2024 May 24.
- Kwok JL, Somani B, Sarica K, Yuen SKK, Zawadzki M, Castellani D, Persaud S, Chai CA, Kamal W, Tefik T, Tursunkulov AN, Soebhali B, Hajj AE, Ko R, Fong KY, Dragos L, Tanidir Y, Angerri O, Traxer O, Gauhar V. Multicenter outcome analysis of different sheath sizes for Flexible and Navigable Suction ureteral access sheath (FANS) ureteroscopy: an EAU Endourology collaboration with the global FANS study group. Urolithiasis. 2024 Nov 15;52(1):162. doi: 10.1007/s00240-024-01662-4.
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Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
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
- Malattie urogenitali
- Malattie urogenitali maschili
- Calcoli
- Condizioni patologiche, anatomiche
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Urolitiasi
- Calcoli urinari
- Nefrolitiasi
- Condizioni patologiche, segni e sintomi
- Calcoli renali
Altri numeri di identificazione dello studio
- ETIK-2026-01
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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