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Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRS

15. června 2026 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

180

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

    • Çorum
      • Çorum, Çorum, Turecko (Türkiye), 19040
        • Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
        • Kontakt:
        • Dílčí vyšetřovatel:
          • AHMET TAŞCI

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Ostatní jména:
  • Standard RIRS Flexible Ureteroscopy
Experimentální: 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.
Ostatní jména:
  • 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.
Ostatní jména:
  • Gentamicin-Containing Irrigation Local Antibiotic Irrigation Intervention Description:
Experimentální: 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.
Ostatní jména:
  • Suction UAS Aspiration Ureteral Access Sheath Suction-Assisted Ureteral Access Sheath
Experimentální: 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.
Ostatní jména:
  • 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.
Ostatní jména:
  • Suction UAS Aspiration Ureteral Access Sheath Suction-Assisted Ureteral Access Sheath

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Postoperative Fever
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Stone-Free Rate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. června 2026

Primární dokončení (Odhadovaný)

8. února 2027

Dokončení studie (Odhadovaný)

8. května 2027

Termíny zápisu do studia

První předloženo

8. června 2026

První předloženo, které splnilo kritéria kontroly kvality

15. června 2026

První zveřejněno (Aktuální)

17. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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