Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRS

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Postoperative Fever — 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.
• Systemic Inflammatory Response Syndrome — 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.
• Sepsis — 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.

Trial sites (2)

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