None listed
Conditions
Brief summary
Gentamicin-Saline irrigation during retrograde intra-renal surgery (RIRS) is a relatively novel approach thought to reduce post-operative infections in specific cohorts. Systemic (IV or oral) antibiotic prophylaxis is well documented, however evidence assessing gentamicin irrigation is small. There is no evidence base assessing Gentamicin irrigation in RIRS in New Zealand cohorts. The study aims to show if Gentamicin-saline irrigation during RIRS yields lower post-operative infection rates than saline alone, which is what current RIRS guidelines recommend.
Interventions
During retrograde intra-renal surgery:
• 80 mg Gentamicin in 2 L 0.9% NaCl (~40 mg/L) irrigation fluid started at laser lithotripsy.
• Gravity irrigation (non-pressurised) 80 cm above pubic symphysis
• Standard rate of 33.3 mL/min (60 min per bag).
• If longer is required remainder of laser operative time 0.9% NaCl Irrigation will be used. Maximum laser operative time is 60 min total.
• Only antibiotics given will be standard preoperative prophylactic antibiotics (e.g. cefazolin 2g)
Surgery
During retrograde intra-renal surgery: • 80 mg Gentamicin in 2 L 0.9% NaCl (~40 mg/L) irrigation fluid started at laser lithotripsy. • Gravity irrigation (non-pressurised) 80 cm above pubic symphysis • Standard rate of 33.3 mL/min (60 min per bag). • If longer is required remainder of laser operative time 0.9% NaCl Irrigation will be used. Maximum laser operative time is 60 min total. • Only antibiotics given will be standard preoperative prophylactic antibiotics (e.g. cefazolin 2g) Surgery will be completed by the Urology operating team assigned to the case. If completed acutely, will be completed by the allocated on-call registrar and consultant. If booked onto an elective theatre list, will be completed by the allocated theatre registrar and consultant. Operating surgeons will not be blinded to the patient selection in intervention/control in the trial. Patients will be randomised by block randomisation, those selected for the intervention will have Gentamicin added to the irrigation bag by the theatre nursing staff. Patients will be consented for the study and the procedure, and will sign a consent form as part of this process. This form will be reviewed as part of the WHO checklist to ensure adherence to the intervention/control.
Sponsors
Te Whatu Ora
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
· Adults (18–80 years) undergoing flexible ureterorenoscopy (RIRS) for intrarenal stone burden less than or equal to 20 mm. Standard practice to consider operative management via percutaneous nephrolithotomy (PCNL) when stone burden is greater than or equal to 20mm. The majority of patients receiving this procedure are in this age range and at this age all patients can provide consent. · Negative pre-operative urine culture, or positive urine cultures treated with greater than or equal to 48 hours of appropriate antibiotics – Sterile urine is required in urology procedures where there is the risk of breaking mucosal lining, in order to reduce the risk of infection. · Any heavy or mixed growth to be treated with Quinolones – Broad-spectrum antibiotic covering both Gram-negative and gram-positive with good urine concentrates. Treatment necessary prior to operation as sterile urine is required in urology procedures where there is the risk of breaking mucosal lining.
Exclusion criteria
· Active urinary tract infection (UTI) - Sterile urine is required in urology procedures where there is the risk of breaking mucosal lining. · Pregnancy or lactation – Gentamicin is contra-indicated during pregnancy and lactation · Known allergy to Gentamicin – High risk of an allergic reaction · eGFR <30 mL/min/1.73 m² - Risk of nephrotoxicity from Gentamicin
Outcome results
None listed