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Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRS
Sponsor: Hitit University
Summary
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.
Official title: The Combined Effect of Antibiotic Irrigation and Aspiration Ureteral Access Sheath on Infectious Complications in Retrograde Intrarenal Surgery: A Prospective Randomized Factorial Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-06-15
Completion Date
2027-05-08
Last Updated
2026-06-17
Healthy Volunteers
No
Interventions
Standard Retrograde Intrarenal Surgery
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.
Gentamicin Irrigation
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.
Suction-Enabled Ureteral Access Sheath
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.
Locations (1)
Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
Çorum, Çorum, Turkey (Türkiye)