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Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRS

15 giugno 2026 aggiornato da: Mustafa Serdar CAGLAYAN, Hitit University

The Combined Effect of Antibiotic Irrigation and Aspiration Ureteral Access Sheath on Infectious Complications in Retrograde Intrarenal Surgery: A Prospective Randomized Factorial Study

Retrograde intrarenal surgery (RIRS) is a widely used treatment for kidney stones; however, postoperative infectious complications remain a significant concern. This prospective randomized factorial trial aims to evaluate whether gentamicin-containing irrigation fluid and the use of a suction ureteral access sheath can reduce postoperative fever, systemic inflammatory response syndrome (SIRS), and sepsis after RIRS. The study will also investigate the independent and combined effects of these two interventions on infectious outcomes.

Panoramica dello studio

Descrizione dettagliata

Subject:

The present study aims to investigate the effects of gentamicin-containing irrigation and the use of a suction ureteral access sheath during retrograde intrarenal surgery (RIRS) on postoperative infectious complications.

Objective:

The aim of this study is to evaluate the independent and combined effects of gentamicin irrigation and a suction ureteral access sheath on postoperative infectious complications following RIRS.

Retrograde intrarenal surgery (RIRS) is a commonly used minimally invasive treatment modality for renal stones, particularly for stones up to 20 mm. Although RIRS is generally considered safe and effective, postoperative infectious complications remain an important clinical concern. Fever, urinary tract infection, systemic inflammatory response syndrome (SIRS), and sepsis may occur even in patients with negative preoperative urine cultures and appropriate perioperative antibiotic prophylaxis.

A potential mechanism for infectious complications after RIRS is increased intrarenal pressure during endoscopic lithotripsy. Elevated intrarenal pressure may promote pyelovenous and pyelolymphatic backflow, allowing bacteria, endotoxins, and inflammatory mediators from the collecting system or stone surface to enter the systemic circulation. Therefore, strategies that reduce bacterial contamination within the renal collecting system and improve intrarenal drainage may help decrease postoperative infectious morbidity.

This study is designed to evaluate two intraoperative strategies intended to reduce infectious complications during RIRS. The first strategy is local antibiotic irrigation using gentamicin-containing saline solution. Gentamicin will be added to the irrigation fluid as a local intraoperative measure rather than as a systemic treatment. This approach is intended to reduce bacterial contamination within the collecting system during lithotripsy. All patients will also receive standard systemic antibiotic prophylaxis according to routine clinical practice.

The second strategy is the use of a suction-enabled ureteral access sheath. This device is intended to improve fluid evacuation, reduce intrarenal pressure, and facilitate the removal of stone dust, debris, and potentially contaminated fluid during the procedure. By improving drainage from the collecting system, suction-assisted RIRS may theoretically reduce pyelovenous backflow and the risk of postoperative systemic inflammatory or infectious events.

The study uses a 2×2 factorial design, which allows simultaneous evaluation of the independent effects of gentamicin irrigation and suction-enabled ureteral access sheath use, as well as their combined effect. This design is useful because both interventions target different mechanisms that may contribute to infectious complications: local bacterial contamination and elevated intrarenal pressure. The factorial structure will also allow assessment of whether the combination of these two approaches provides an additive or synergistic benefit compared with either intervention alone.

All procedures will be performed under general anesthesia in the lithotomy position using standard endourological techniques. Irrigation will be performed with normal saline under low-pressure conditions. In the gentamicin irrigation groups, 80 mg gentamicin will be added to each 3 L bag of normal saline. In the suction groups, a suction-enabled ureteral access sheath will be used during flexible ureteroscopy. Stone fragmentation will be performed with a holmium:YAG laser using a dusting technique, and a double-J ureteral stent will be placed at the end of the procedure according to the study protocol.

This trial may provide clinically relevant evidence regarding infection-prevention strategies in RIRS. If gentamicin irrigation, suction-assisted access sheath use, or their combination is shown to reduce postoperative infectious complications without compromising surgical success, these approaches may contribute to safer perioperative management in endourological stone surgery.

Tipo di studio

Interventistico

Iscrizione (Stimato)

180

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Çorum
      • Çorum, Çorum, Turchia (Türkiye), 19040
        • Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
        • Contatto:
        • Sub-investigatore:
          • AHMET TAŞCI

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Patients scheduled for retrograde intrarenal surgery (RIRS) due to kidney stones
  • Male and female patients aged 18 years or older
  • Patients who voluntarily sign the informed consent form
  • Patients with sterile urine culture or whose preoperative infection has been treated and urine culture has become sterile

Exclusion Criteria:

  • Patients with active urinary tract infection before surgery
  • Patients with chronic kidney disease
  • Pregnant patients
  • Patients with allergy to aminoglycoside-group drugs used in the study protocol, specifically gentamicin
  • Cases in which the ureter cannot be accessed and the procedure is postponed by placing a double-J stent instead of performing dilation

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Standard RIRS
Participants in this arm will undergo standard retrograde intrarenal surgery using standard saline irrigation and a standard ureteral access sheath. This arm will serve as the control group for comparison with gentamicin irrigation, suction-enabled ureteral access sheath use, and the combined intervention.
Standard retrograde intrarenal surgery will be performed under general anesthesia in the lithotomy position. A guidewire will be advanced to the renal pelvis under fluoroscopic guidance, and a ureteral access sheath will be placed when appropriate. Flexible ureteroscopy will be performed, and stones will be fragmented using a holmium laser with the dusting technique. Standard saline irrigation will be used during the procedure.
Altri nomi:
  • Standard RIRS Flexible Ureteroscopy
Sperimentale: Standard RIRS With Gentamicin Irrigation

Arm Description:

Participants in this arm will undergo standard retrograde intrarenal surgery using gentamicin-containing irrigation fluid. Gentamicin will be added to normal saline irrigation solution during the procedure. A standard ureteral access sheath will be used without suction assistance.

Standard retrograde intrarenal surgery will be performed under general anesthesia in the lithotomy position. A guidewire will be advanced to the renal pelvis under fluoroscopic guidance, and a ureteral access sheath will be placed when appropriate. Flexible ureteroscopy will be performed, and stones will be fragmented using a holmium laser with the dusting technique. Standard saline irrigation will be used during the procedure.
Altri nomi:
  • Standard RIRS Flexible Ureteroscopy
Gentamicin-containing irrigation fluid will be used during retrograde intrarenal surgery. In the gentamicin irrigation groups, 80 mg gentamicin will be added to each 3 L bag of normal saline irrigation solution. This intervention will be used as a local intraoperative irrigation strategy to reduce bacterial contamination within the renal collecting system and is not intended as systemic antibiotic treatment.
Altri nomi:
  • Gentamicin-Containing Irrigation Local Antibiotic Irrigation Intervention Description:
Sperimentale: Suction RIRS
Participants in this arm will undergo retrograde intrarenal surgery using a suction-enabled ureteral access sheath. The suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure. Standard saline irrigation will be used without gentamicin.
A suction-enabled ureteral access sheath will be used during retrograde intrarenal surgery in the suction groups. The device is intended to improve fluid evacuation from the renal collecting system, reduce intrarenal pressure, and facilitate removal of irrigation fluid, stone dust, and debris during flexible ureteroscopy.
Altri nomi:
  • Suction UAS Aspiration Ureteral Access Sheath Suction-Assisted Ureteral Access Sheath
Sperimentale: Suction RIRS With Gentamicin Irrigation
Participants in this arm will undergo retrograde intrarenal surgery using both gentamicin-containing irrigation fluid and a suction-enabled ureteral access sheath. Gentamicin will be added to normal saline irrigation solution, and the suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure.
Gentamicin-containing irrigation fluid will be used during retrograde intrarenal surgery. In the gentamicin irrigation groups, 80 mg gentamicin will be added to each 3 L bag of normal saline irrigation solution. This intervention will be used as a local intraoperative irrigation strategy to reduce bacterial contamination within the renal collecting system and is not intended as systemic antibiotic treatment.
Altri nomi:
  • Gentamicin-Containing Irrigation Local Antibiotic Irrigation Intervention Description:
A suction-enabled ureteral access sheath will be used during retrograde intrarenal surgery in the suction groups. The device is intended to improve fluid evacuation from the renal collecting system, reduce intrarenal pressure, and facilitate removal of irrigation fluid, stone dust, and debris during flexible ureteroscopy.
Altri nomi:
  • Suction UAS Aspiration Ureteral Access Sheath Suction-Assisted Ureteral Access Sheath

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative Fever
Lasso di tempo: Within 48 hours after surgery
Postoperative fever will be defined as a body temperature greater than 38°C occurring within the first 48 hours after retrograde intrarenal surgery.
Within 48 hours after surgery
Systemic Inflammatory Response Syndrome
Lasso di tempo: Within 48 hours after surgery
Systemic inflammatory response syndrome will be defined as the presence of at least two of the following criteria: body temperature greater than 38°C or less than 36°C, heart rate greater than 90 beats/min, respiratory rate greater than 20 breaths/min, or white blood cell count greater than 12,000/mm³ or less than 4,000/mm³.
Within 48 hours after surgery
Sepsis
Lasso di tempo: Within 48 hours after surgery
Sepsis will be defined as systemic inflammatory response syndrome in the presence of confirmed or suspected infection after retrograde intrarenal surgery.
Within 48 hours after surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Stone-Free Rate
Lasso di tempo: 4 weeks after surgery
Stone-free status will be evaluated using non-contrast computed tomography. Residual fragments of 4 mm or less will be considered clinically insignificant.
4 weeks after surgery
Change in White Blood Cell Count
Lasso di tempo: Baseline and within 48 hours after surgery
White blood cell count will be assessed before and after surgery to evaluate postoperative inflammatory response.
Baseline and within 48 hours after surgery
Change in Serum Creatinine
Lasso di tempo: Baseline and within 48 hours after surgery
Serum creatinine levels will be assessed before and after surgery to evaluate renal function changes.
Baseline and within 48 hours after surgery
Urine Culture Positivity
Lasso di tempo: Within 48 hours after surgery
Postoperative urine culture results will be evaluated to identify urinary tract infection and causative microorganisms.
Within 48 hours after surgery
Blood Culture Positivity
Lasso di tempo: Within 48 hours after surgery
Postoperative blood culture results will be evaluated in patients with suspected systemic infection to identify bloodstream infection and causative microorganisms.
Within 48 hours after surgery

Collaboratori e investigatori

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Pubblicazioni e link utili

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Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 giugno 2026

Completamento primario (Stimato)

8 febbraio 2027

Completamento dello studio (Stimato)

8 maggio 2027

Date di iscrizione allo studio

Primo inviato

8 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

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