Comparison Of Postoperative Infection Rates With Multiple-,Single-,Zerodose Of Ciprofloxacin Prophylaxis In Retrograde Intrarenal Surgery: A Prospective Randomized Controlled Study

Background:Retrograde intrarenal surgery(RIRS)was a well established procedure in management of renal stones.With the advantage of minimalinvasiveness,safety and effectivity,RIRS has been widely used and become one of the important methods for the treatment of upper urinary tract stones.Although the efficacy and safety of RIRS have increased with the development of endoscopic instrumentsand technique in the last decade,postoperative infection is still one of the most common complications after RIRS with an incidence reported upto25.0%.Infections can not only increase postoperative length of stay,hospitalreadmission rates,and the use of antimicrobial agents,but also serious threat to patient safety.Therefore,the prevention of postoperative infections has always been an importantclinical goal in RIRS surgery.Perioperativeantibiotic prophylaxisiswidely used inurologicprocedures and is an acknowledged strategyto preventpostoperative infectious complications,while abuse of antibiotics will concomitantlyincrease theprevalence of bacterial resistance.The principleof antibiotic prophylaxisisnot only toensure individualpatient's safety with minimizedantibiotics,but also to reducetheriskof emergingresistantbacteriaandmedical costs.Without the consistency of the duration of antibiotic prophylaxis,several studies have demonstrated the necessity and effectiveness of perioperativeantibiotic prophylaxis in declining postoperative infections during percutaneous nephrolithotomy.Guidelinesacknowledge that little recommend exists for the systematic antibioticprophylaxis of patients undergoing RIRSand theirrecommendations for prophylaxisregarding the choice of antibiotic,dose and duration are based on low evidence.To explore theoptimalantibiotic prophylaxisapproach forRIRS,a single-center prospective randomize trialcomparingthe zero-dose,single-dose andtwo-dosesof prophylactic antibiotics wasconductedin low-risk patients with preoperative sterile urine,andthe outcomes were reported.We mean to detect an appropriate prophylactic drug regimen for RIRS to reduce the abuse and resistance of antibiotic.Objective:To present a prospective randomize trail in comparison of multiple-,single-,zero-dose antibiotic prophylaxis in RIRS,and investigate the ideal protocol for antibiotic prophylaxis in RIRS.Materials and MethodsA prospective randomized trialwas conducted between August 2014 and November 2016.300 consecutive patients with preoperative sterile urine undergoing RIRSwere randomized into three groups and received ciprofloxacin-based different ABP regimes(group 1,zero-dose;group 2,single dose,30 min before the surgery;group 3,two doses,first doseat 30 min before the surgeryandadditional dose within 6 hoursafter surgery).Data for the three groups patients demographic characteristics,stones characteristics(size,location,density,composition),hydronephrosis,pre-and post-operative WBC,hemoglobin and creatinine,operation time,irrigation,duration of postoperative hospital stay,stone free rate and complicationsare recorded and compared.The primary endpoint wasthe systemic inflammatory response syndrome(SIRS).Results1.Three hundred patients were randomized into the three groups.After randomization,35 patients were excluded from the study because of either turbid pelvic urine,purulent stone surface observed intra-operatively,ureteral stricture,conversion of PCNLdue to the failure of reaching the stones,thus,a total of 265 patients(zero-dose group: 88,single-dose group: 88,multiple-dose group:89)were eligible for final analysis.2.The baseline of the patients and stones related characteristics were comparable among the three groups.No significant differences were observed among the groups in age,sex,body mass index,hypertension,history of surgery,stone size,location,density and composition,hydronephrosis,pre-and post-operative WBC,hemoglobin and creatinine,operation time,irrigation,duration of postoperative hospital stay,stone free rate(p>0.05).3.Overall postoperative SIRS was noted in 12(4.5%)of all patients.Identified SIRS was recorded in 8(9.1%),3(3.4%)and 1(1.2%)patients in zero-,single-,multiple-dose group,respectively(p>0.05).In subgroup analysis according the stone area,SIRS occurred respectively in 5.0%,5.1% and 0% of patients with stones ? 200 mm2,without significant difference between any of two groups(p=0.257);for stones >200 mm2,a higher SIRS rate(17.9%)were developed in zero-dose group,which is significant higher thansingle-and multiple-dose group(p=0.011).All of these 12 patients were cured and no urosepsis was developed in any groups.Conclusion:1.RIRS without antibiotic prophylaxis is safe for patients with preoperative sterile urine andstones ?200 mm2,and prophylactic antibiotics are not recommended for those patients.2.However,single dose prophylaxis seems necessary andsufficientfor patients with stones>200 mm2.3.Multi-centers trialwith a larger sample size should be conducted to verify our experimental results again.