[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659415":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":33,"studyPopulation":24,"armGroups":34,"interventions":47,"overallOfficials":24,"centralContacts":57,"locations":67,"responsibleParty":85,"collaborators":24,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":24,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":24,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":70,"whyStopped":24,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Hitit University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Postoperative Fever","Number and percentage of participants with a recorded body temperature \\>38°C within 48 hours after surgery.","Within 48 hours after surgery",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Incidence of Postoperative Systemic Inflammatory Response Syndrome","Number and percentage of participants meeting at least two of the following criteria: temperature \\>38°C or \\\u003C36°C, heart rate \\>90 beats\u002Fmin, respiratory rate \\>20 breaths\u002Fmin, or white blood cell count \\>12,000\u002Fmm³ or \\\u003C4,000\u002Fmm³.",{"measure":18,"description":19,"timeFrame":12},"Incidence of Postoperative Sepsis","Number and percentage of participants with suspected or confirmed infection who also meet the protocol-defined systemic inflammatory response syndrome criteria.",{"measure":21,"description":22,"timeFrame":23},"Stone-Free Rate","Number and percentage of participants with no residual stone or residual fragments ≤4 mm on non-contrast computed tomography.","4 weeks after surgery",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":31},"SINGLE",[32],"OUTCOMES_ASSESSOR","Retrograde intrarenal surgery (RIRS) is used to treat renal and proximal ureteral stones. During flexible ureterorenoscopy, stone fragments and irrigation fluid may impair visualization, and elevated intrarenal pressure may contribute to postoperative infectious complications. Direct in-scope suction (DISS) permits aspiration through the ureterorenoscope during irrigation and lithotripsy. This study will compare procedural and postoperative outcomes with and without DISS.\n\nThis single-center, prospective, randomized, parallel-group study will enroll 70 adults undergoing RIRS at Erol Olçok Training and Research Hospital. Participants will be assigned in a 1:1 ratio to standard flexible ureterorenoscopy or DISS-equipped flexible ureterorenoscopy using a computer-generated randomization sequence. Each group will include 35 participants. Clinical data will be collected during surgery and postoperative follow-up.\n\nThe standard group will undergo surgery using a 7.5 Fr Storz Flex-X2 flexible ureterorenoscope. The DISS group will undergo surgery using a 7.5 Fr single-use Claritron flexible ureterorenoscope with direct in-scope suction. Both groups will use a 9.5\u002F11.5 Fr ureteral access sheath, guidewire, Holmium:YAG laser lithotripsy, and normal saline irrigation. Procedures will be performed under general anesthesia in the lithotomy position, with the irrigation bag positioned approximately 100 cm above the patient.\n\nEligible patients will be aged 18 years or older and undergo RIRS by the same surgical team for a single renal or proximal ureteral stone. Patients with multiple stones, pregnancy, preoperative urinary tract infection, or bleeding diathesis will be excluded.\n\nDemographic and stone characteristics, operative time, fluoroscopy time, total laser energy, length of hospital stay, and need for reoperation will be recorded. Laboratory results, including white blood cell count, C-reactive protein, and creatinine, as well as urine and blood culture results when obtained, will be collected during follow-up.\n\nThe primary outcomes are postoperative fever, systemic inflammatory response syndrome (SIRS), and sepsis. Fever is defined as a body temperature \\>38°C within 48 hours after surgery. SIRS is defined as the presence of at least two of the following: temperature \\>38°C or \\\u003C36°C, heart rate \\>90 beats\u002Fmin, respiratory rate \\>20 breaths\u002Fmin, or white blood cell count \\>12,000\u002Fmm³ or \\\u003C4,000\u002Fmm³. For this protocol, sepsis is defined as SIRS with suspected or confirmed infection. For patients who develop infectious complications, treatment, intravenous antibiotic use, and intensive care requirements will be recorded.\n\nSecondary outcomes include stone-free status on non-contrast computed tomography approximately four weeks after surgery, postoperative changes in white blood cell count and creatinine, and postoperative culture findings. Residual fragments ≤4 mm will be classified as clinically insignificant for the study's stone-free assessment.\n\nThe two groups will be compared using tests appropriate for the distribution and type of each variable. Categorical data will be reported as counts and percentages. A p value \\\u003C0.05 will be considered statistically significant.",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Standard Flexible Ureterorenoscopy","ACTIVE_COMPARATOR","Participants randomized to this arm will undergo retrograde intrarenal surgery using a 7.5 Fr Storz Flex-X2 flexible ureterorenoscope without direct in-scope suction. A 9.5\u002F11.5 Fr ureteral access sheath, Holmium:YAG laser lithotripsy, and normal saline irrigation will be used.",[40],"Device: Standard flexible ureterorenoscope",{"label":42,"type":43,"description":44,"interventionNames":45},"Direct In-Scope Suction Flexible Ureterorenoscopy","EXPERIMENTAL","Participants randomized to this arm will undergo retrograde intrarenal surgery using a 7.5 Fr single-use Claritron flexible ureterorenoscope equipped with direct in-scope suction. A 9.5\u002F11.5 Fr ureteral access sheath, Holmium:YAG laser lithotripsy, and normal saline irrigation will be used.",[46],"Device: Flexible ureterorenoscope with direct in-scope suction",[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":24},"DEVICE","Standard flexible ureterorenoscope","A 7.5 Fr reusable Storz Flex-X2 flexible ureterorenoscope without direct in-scope suction will be used for retrograde intrarenal surgery. Stone fragmentation will be performed with a Holmium:YAG laser through a 9.5\u002F11.5 Fr ureteral access sheath.",[36],{"type":49,"name":54,"description":55,"armGroupLabels":56,"otherNames":24},"Flexible ureterorenoscope with direct in-scope suction","A 7.5 Fr single-use Claritron flexible ureterorenoscope equipped with direct in-scope suction will be used for retrograde intrarenal surgery. Suction through the scope will be available during irrigation and Holmium:YAG laser lithotripsy. A 9.5\u002F11.5 Fr ureteral access sheath will be used.",[42],[58,63],{"name":59,"role":60,"phone":61,"phoneExt":24,"email":62},"MUSTAFA SERDAR ÇAĞLAYAN","CONTACT","+90 507 431 1951","serdar.09.09@hotmail.com",{"name":64,"role":60,"phone":65,"phoneExt":24,"email":66},"AHMET TAŞCI","+905531596690","ahmettasci400@gmail.com",[68],{"facility":69,"status":70,"city":71,"state":71,"zip":72,"country":73,"countryCode":24,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye","RECRUITING","Çorum","19040","Turkey (Türkiye)",{"type":75,"coordinates":76},"Point",[77,78],34.95333,40.54889,{"lat":78,"lon":77},[81,83],{"name":64,"role":60,"phone":82,"phoneExt":24,"email":66},"05531596690",{"name":64,"role":84,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Mustafa Serdar CAGLAYAN","Research Assistant Doctor","100659415","direct-in-scope-suction-versus-standard-flexible-ureterorenoscopy-100659415",false,"NCT07864194","Direct In-Scope Suction Versus Standard Flexible Ureterorenoscopy","Flexible Ureterorenoscope With Suction: An Innovative Approach","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* A single stone located in the kidney or proximal ureter.\n* Scheduled to undergo retrograde intrarenal surgery (RIRS) by the study's surgical team.\n\nExclusion Criteria:\n\n* Multiple renal or proximal ureteral stones.\n* Age younger than 18 years.\n* Pregnancy.\n* Preoperative urinary tract infection.\n* Bleeding diathesis.","ALL","18 Years","75 Years",{"count":100,"type":101},70,"ESTIMATED","INTERVENTIONAL",[104],"NA","This prospective study aims to compare the clinical, perioperative, and postoperative outcomes of flexible ureterorenoscopy using a direct in-scope suction system (DISS) with standard flexible ureterorenoscopy in patients undergoing retrograde intrarenal surgery for renal or proximal ureteral stones. A total of 70 patients will be enrolled, with 35 patients in each group. The study will assess postoperative infectious complications, including fever, systemic inflammatory response syndrome (SIRS), and sepsis, as well as operative parameters, length of hospital stay, reoperation, and stone-free status. Stone-free status will be assessed by non-contrast computed tomography four weeks after surgery.",[107],"Renal Stone Disease",[109,110,111,112,113],"Retrograde intrarenal surgery (RIRS)","Kidney stone","Infectious complications","Urinary tract infection","Sepsis","2026-10-04",{"date":116,"type":117},"2026-10-07","ACTUAL",{"date":119,"type":117},"2026-07-07",{"date":121,"type":101},"2026-11-15",{"name":5,"class":6},1]