Rationale:
Preoperative 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.
Objective:
The 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.
Study design:
The Virtual Renality study is a single-center randomized clinical trial conducted at the St. Antonius Hospital in Nieuwegein.
Study population:
The study population will consist of adult patients (18+) with a suspected RCC who are indicated for (partial) nephrectomy at St. Antonius Hospital Nieuwegein.
Intervention:
For 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.
Main study parameters/endpoints:
The primary study endpoint is the surgical concordance score, which describes the concordance between the actual performed surgery and the preoperatively determined surgical plan.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness:
Participation 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.
18+
Suspected RCC and candidate for (partial) nephrectomy
Signed informed consent
Patients who are not approved to undergo surgery (due to comorbidities or their overall health condition)
Patients who are unable to give informed consent
Parallel
Virtual reality
DeviceIf 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.
Concordance score between actual performed surgery and surgical plan
To assess whether the surgery is performed according to the preoperative plan, a questionnaire regarding the expected surgical steps will be completed during the preoperative planning. Postoperatively, the data will be collected from the surgical notes. The postoperative data will be compared with the preoperatively filled questionnaire and this will result in a concordance score between the actual performed surgery and the preoperatively determined surgical plan. This score of concordance will be the primary study endpoint
Intra-operative parameters: method of clamping
Method of clamping (main renal artery / multiple arteries / no clamping / selective clamping)
Intraoperative parameters: blood loss
blood loss (value in ml)
Intraoperative parameters: clamping time
clamping time (value in mm:ss)
Intraoperative parameters: opening of collecting system
opening of collecting system (yes/no)
Demographic data - age
Age (Years (at time of surgery) )
Demographic data - gender
Gender (Male / Female )
Medical data - BMI
BMI (Kg/m2)
Medical data - ASA-score
ASA-score ( I / II / III / IV / V)
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