[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641920":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":50,"centralContacts":51,"locations":61,"responsibleParty":93,"collaborators":50,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":50,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":50,"enrollmentInfo":105,"targetDuration":50,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":82,"whyStopped":50,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Hitit University","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard RIRS","EXPERIMENTAL","Participants in this arm will undergo standard retrograde intrarenal surgery using standard saline irrigation and a standard ureteral access sheath. This arm will serve as the control group for comparison with gentamicin irrigation, suction-enabled ureteral access sheath use, and the combined intervention.",[13],"Procedure: Standard Retrograde Intrarenal Surgery",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard RIRS With Gentamicin Irrigation","Arm Description:\n\nParticipants in this arm will undergo standard retrograde intrarenal surgery using gentamicin-containing irrigation fluid. Gentamicin will be added to normal saline irrigation solution during the procedure. A standard ureteral access sheath will be used without suction assistance.",[13,18],"Drug: Gentamicin Irrigation",{"label":20,"type":10,"description":21,"interventionNames":22},"Suction RIRS","Participants in this arm will undergo retrograde intrarenal surgery using a suction-enabled ureteral access sheath. The suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure. Standard saline irrigation will be used without gentamicin.",[23],"Device: Suction-Enabled Ureteral Access Sheath",{"label":25,"type":10,"description":26,"interventionNames":27},"Suction RIRS With Gentamicin Irrigation","Participants in this arm will undergo retrograde intrarenal surgery using both gentamicin-containing irrigation fluid and a suction-enabled ureteral access sheath. Gentamicin will be added to normal saline irrigation solution, and the suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure.",[18,23],[29,36,43],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"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.",[9,15],[35],"Standard RIRS Flexible Ureteroscopy",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"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.",[15,25],[42],"Gentamicin-Containing Irrigation Local Antibiotic Irrigation Intervention Description:",{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"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.",[20,25],[49],"Suction UAS Aspiration Ureteral Access Sheath Suction-Assisted Ureteral Access Sheath",null,[52,57],{"name":53,"role":54,"phone":55,"phoneExt":50,"email":56},"MUSTAFA SERDAR ÇAĞLAYAN","CONTACT","+90 507 431 1951","serdar.09.09@hotmail.com",{"name":58,"role":54,"phone":59,"phoneExt":50,"email":60},"AHMET TAŞCI","+905531596690","ahmettasci400@gmail.com",[62,81],{"facility":63,"status":64,"city":65,"state":65,"zip":66,"country":67,"countryCode":50,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye","NOT_YET_RECRUITING","Çorum","19040","Turkey (Türkiye)",{"type":69,"coordinates":70},"Point",[71,72],34.95333,40.54889,{"lat":72,"lon":71},[75,79],{"name":76,"role":54,"phone":77,"phoneExt":50,"email":78},"MUSA EKİCİ","+90364 222 11 02","tipfak@hitit.edu.tr",{"name":58,"role":80,"phone":50,"phoneExt":50,"email":50},"SUB_INVESTIGATOR",{"facility":63,"status":82,"city":65,"state":65,"zip":66,"country":67,"countryCode":50,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},"RECRUITING",{"type":69,"coordinates":84},[71,72],{"lat":72,"lon":71},[87,90,92],{"name":76,"role":54,"phone":88,"phoneExt":50,"email":89},"+90 505 751 63 41","musaekici@hitit.edu.tr",{"name":53,"role":91,"phone":50,"phoneExt":50,"email":50},"PRINCIPAL_INVESTIGATOR",{"name":58,"role":80,"phone":50,"phoneExt":50,"email":50},{"type":91,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Mustafa Serdar CAGLAYAN","Assistant Professor","100641920","antibiotic-irrigation-and-suction-ureteral-access-sheath-in-rirs-100641920",false,"NCT07655050","Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRS","The Combined Effect of Antibiotic Irrigation and Aspiration Ureteral Access Sheath on Infectious Complications in Retrograde Intrarenal Surgery: A Prospective Randomized Factorial Study","Inclusion Criteria:\n\n* Patients scheduled for retrograde intrarenal surgery (RIRS) due to kidney stones\n* Male and female patients aged 18 years or older\n* Patients who voluntarily sign the informed consent form\n* Patients with sterile urine culture or whose preoperative infection has been treated and urine culture has become sterile\n\nExclusion Criteria:\n\n* Patients with active urinary tract infection before surgery\n* Patients with chronic kidney disease\n* Pregnant patients\n* Patients with allergy to aminoglycoside-group drugs used in the study protocol, specifically gentamicin\n* Cases in which the ureter cannot be accessed and the procedure is postponed by placing a double-J stent instead of performing dilation","ALL","18 Years",{"count":106,"type":107},180,"ESTIMATED","INTERVENTIONAL",[110],"NA","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.",[113,114,115],"Kidney Calculi","Urolithiasis","Urinary Tract Infections",[117,118,119,120,121,122,123],"Retrograde intrarenal surgery","Kidney stone","Gentamicin","Irrigation fluid","Infectious complications","Urinary tract infection","SEPSİS","2026-06-21",{"date":126,"type":127},"2026-06-24","ACTUAL",{"date":129,"type":127},"2026-06-15",{"date":131,"type":107},"2027-05-08",{"name":5,"class":6},2]