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Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRS

NCT07655050 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-06-24

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

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.

DRUG

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.

DEVICE

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.

Sponsors & Collaborators

  • Hitit University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-02-08
Completion
2027-05-08

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07655050 on ClinicalTrials.gov