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Virtual Renality: Assessing the Impact of Virtual Reality on Preoperative Planning in Renal Cancer Surgery

Virtual Renality: Assessing the Impact of Virtual Reality on Preoperative Planning in Renal Cancer Surgery

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06960174
Enrollment
70
Registered
2025-05-07
Start date
2025-06-02
Completion date
2026-01-31
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma (Kidney Cancer)

Keywords

Renal Cell Carcinoma, Partial nephrectomy, Radical nephrectomy, Preoperative planning, 3D virtual model, Virtual Reality

Brief summary

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.

Detailed description

The Virtual Renality study is a single-center randomized clinical trial conducted at the St. Antonius Hospital in Nieuwegein. 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, whereas for the control group, only the CT scan will be used for preoperative planning, according to the current standard of care. The flowchart in Figure 1 provides an overview of the study design. The steps covered in the flowchart and the collection of parameters will be further explained later in this protocol. The study is single-blinded, as the 3D virtual model during preoperative planning is the assessed intervention. Participants will be randomly assigned to either the control group or the intervention group to eliminate selection bias and achieve comparability between the two groups. The urologists who perform (partial) nephrectomies at the St. Antonius Hospital will participate in the study. A total of 72 patients suspected of having a renal tumor and indicated for (partial) nephrectomy will be included. The inclusion period for the study will take approximately 7 months.

Interventions

DEVICEVirtual 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.

Sponsors

St. Antonius Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18+ * Suspected RCC and candidate for (partial) nephrectomy * Signed informed consent

Exclusion criteria

* Patients who are not approved to undergo surgery (due to comorbidities or their overall health condition) * Patients who are unable to give informed consent

Design outcomes

Primary

MeasureTime frameDescription
Concordance score between actual performed surgery and surgical planduring preoperative planning (approximately 3 days before surgery) and immediately after surgeryTo 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

Secondary

MeasureTime frameDescription
Intraoperative parameters: clamping timePerioperativeclamping time (value in mm:ss)
Intraoperative parameters: duration of surgeryPerioperativeduration of surgery (value in minutes)
Post-operative parameters: renal functionUp to 1 month post-surgeryRenal function (Creatinine level before surgery, 1 day post-surgery and 4 weeks post-surgery )
Post-operative parameters: 30-day post-surgery complications30 days post-surgery30-day post-surgery complications ( Clavien Dindo score (Grade I / Grade II / Grade IIIa / Grade IIIb / Grade IVa / Grade IVb / Grade V) )
Post-operative parameters: hospital stay30-days post-surgeryhospital stay (days)
Post-operative parameters: readmission (within 30 days)30-days post-surgeryreadmission (within 30 days) (yes/no)
Post-operative parameters: clean resection margin30-days post-surgeryclean resection margin (yes/no)
Post-operative parameters:30-days post-surgerypathological TNM (TxNxMx)
Understanding of anatomy - renal arteriesduring preoperative planning (approximately 3 days before surgery) and immediately after surgeryUnderstanding of renal arteries (Very poor / Poor / Moderate / Good / Excellent)
Understanding of anatomy - renal veinsduring preoperative planning (approximately 3 days before surgery) and immediately after surgeryUnderstanding of renal veins (Very poor / Poor / Moderate / Good / Excellent)
Understanding of anatomy - collecting systemduring preoperative planning (approximately 3 days before surgery) and immediately after surgeryUnderstanding of collecting system (Very poor / Poor / Moderate / Good / Excellent)
Understanding of anatomy - tumorduring preoperative planning (approximately 3 days before surgery) and immediately after surgeryUnderstanding of tumor anatomy (Very poor / Poor / Moderate / Good / Excellent)
Understanding of anatomy - general anatomyduring preoperative planning (approximately 3 days before surgery)Confidence in understanding of general anatomy (Strongly disagree / Disagree / Neutral / Agree / Strongly agree)
Intra-operative parameters: method of clampingPerioperativeMethod of clamping (main renal artery / multiple arteries / no clamping / selective clamping)
Intraoperative parameters: blood lossPerioperativeblood loss (value in ml)
Intraoperative parameters: opening of collecting systemPerioperativeopening of collecting system (yes/no)

Other

MeasureTime frameDescription
Medical data - BMIbefore surgeryBMI (Kg/m2)
Medical data - ASA-scorebefore surgeryASA-score ( I / II / III / IV / V)
Medical data - history of smokingbefore surgeryHistory of smoking (Packyears (or yes/no) )
Medical data - comorbiditiesbefore surgeryComorbidities (Charlson comorbidity index, 0-37))
Medical data - radiological TNMbefore surgeryRadiological TNM classification (TxNxMx )
Medical data - RENALbefore surgeryRENAL score (4-12 a/p/h)
Medical data - tumor sidebefore surgerySide of tumor(Left/right)
Medical data - tumor sizebefore surgerySize of tumor (mm)
Medical data - CT typebefore surgeryType of CT (Contrast enhanced (which phases)/photon counting)
Medical data - surgeonbefore surgerySurgeon (Name / number )
Demographic data - agebefore surgeryAge (Years (at time of surgery) )
Demographic data - genderbefore surgeryGender (Male / Female )

Contacts

Primary ContactEmma Trouw, BSc
e.trouw@antoniusziekenhuis.nl0031616501192

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026