Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHitit University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
Standard Retrograde Intrarenal Surgery
Procedure/SurgeryStandard 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
DrugGentamicin-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
DeviceA 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.
Treatment groups
180 Participants
are divided into 4 treatment groupsGroup A: Standard RIRSExperimental treatment 1 intervention
Group B: Standard RIRS With Gentamicin IrrigationExperimental treatment 2 interventions
Group C: Suction RIRSExperimental treatment 1 intervention
Group D: Suction RIRS With Gentamicin IrrigationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Postoperative Fever
Postoperative fever will be defined as a body temperature greater than 38°C occurring within the first 48 hours after retrograde intrarenal surgery.
Time frame
Within 48 hours after surgery2
Systemic Inflammatory Response Syndrome
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.
Time frame
Within 48 hours after surgery3
Sepsis
Sepsis will be defined as systemic inflammatory response syndrome in the presence of confirmed or suspected infection after retrograde intrarenal surgery.
Time frame
Within 48 hours after surgerySecondary outcomes
1
Stone-Free Rate
Stone-free status will be evaluated using non-contrast computed tomography. Residual fragments of 4 mm or less will be considered clinically insignificant.
Time frame
4 weeks after surgery2
Change in White Blood Cell Count
White blood cell count will be assessed before and after surgery to evaluate postoperative inflammatory response.
Time frame
Baseline and within 48 hours after surgery3
Change in Serum Creatinine
Serum creatinine levels will be assessed before and after surgery to evaluate renal function changes.
Time frame
Baseline and within 48 hours after surgery4
Urine Culture Positivity
Postoperative urine culture results will be evaluated to identify urinary tract infection and causative microorganisms.
Time frame
Within 48 hours after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov