[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589881":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":12,"responsibleParty":31,"collaborators":12,"id":35,"slug":12,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":12,"eligibilityCriteria":39,"healthyVolunteers":36,"sex":40,"minAge":41,"maxAge":12,"enrollmentInfo":42,"targetDuration":12,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":58,"whyStopped":12,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":12},{"fullName":5,"class":6},"St. Antonius Hospital","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Preoperative planning based on CT","NO_INTERVENTION","For the control group the preoperative planning will be according to the current standard of care using only the CT scan.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Preoperative planning based on CT + VR","EXPERIMENTAL","For the intervention group, the urologist will review a 3D virtual model of the renal anatomy in addition to the CT scan during preoperative planning",[18],"Device: Virtual reality",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Virtual reality","If the participant is assigned to the intervention group a 3D virtual model will be constructed. For the intervention group the CT + VR will be reviewed during preoperative planning.",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Emma Trouw, BSc","CONTACT","0031616501192","e.trouw@antoniusziekenhuis.nl",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Hille Torenvlied","Principal Investigator","100589881",false,"NCT06960174","Virtual Renality: Assessing the Impact of Virtual Reality on Preoperative Planning in Renal Cancer Surgery","Inclusion Criteria:\n\n* 18+\n* Suspected RCC and candidate for (partial) nephrectomy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients who are not approved to undergo surgery (due to comorbidities or their overall health condition)\n* Patients who are unable to give informed consent","ALL","18 Years",{"count":43,"type":44},70,"ESTIMATED","INTERVENTIONAL",[47],"NA","Rationale:\n\nPreoperative planning for both partial and radical nephrectomies using conventional CT imaging can be challenging due to complex renal anatomy and vascularization. 3D models in virtual reality (VR) may enhance anatomical understanding and improve preoperative planning. This study aims to prospectively evaluate the clinical impact of the use of 3D models in VR in the preoperative planning of partial and radical nephrectomies.\n\nObjective:\n\nThe primary objective is to assess the impact of VR on preoperative planning and thereby on the agreement between the preoperative plan and the performed surgery in renal surgery (both partial and radical nephrectomies). The secondary objectives focus on the urologist's understanding of the anatomy and how the intraoperative and postoperative outcomes are influenced by the use of VR in the preoperative planning.\n\nStudy design:\n\nThe Virtual Renality study is a single-center randomized clinical trial conducted at the St. Antonius Hospital in Nieuwegein.\n\nStudy population:\n\nThe study population will consist of adult patients (18+) with a suspected RCC who are indicated for (partial) nephrectomy at St. Antonius Hospital Nieuwegein.\n\nIntervention:\n\nFor the intervention group, the urologist will review a 3D virtual model of the renal anatomy in addition to the original CT scan during preoperative planning. For the control group, only the CT scan will be used for preoperative planning, according to the current standard of care.\n\nMain study parameters\u002Fendpoints:\n\nThe primary study endpoint is the surgical concordance score, which describes the concordance between the actual performed surgery and the preoperatively determined surgical plan.\n\nNature and extent of the burden and risks associated with participation, benefit, and group relatedness:\n\nParticipation in this study will not require any additional physical examinations, blood samples, hospital visits, or questionnaires beyond standard clinical care. The only difference for participants in the intervention group is that a 3D model will be created from the existing CT scan and reviewed in VR during preoperative planning by the urologist.",[50],"Renal Cell Carcinoma (Kidney Cancer)",[52,53,54,55,56,57],"Renal Cell Carcinoma","Partial nephrectomy","Radical nephrectomy","Preoperative planning","3D virtual model","Virtual Reality","NOT_YET_RECRUITING","2025-04-28",{"date":61,"type":62},"2025-05-07","ACTUAL",{"date":64,"type":44},"2025-06-02",{"date":66,"type":44},"2026-01-31",{"name":5,"class":6}]