Clinical trial NCT06960174: Virtual Renality: Assessing the Impact of Virtual Reality on Preoperative Planning in Renal Cancer Surgery
Official title: Virtual Renality: Assessing the Impact of Virtual Reality on Preoperative Planning in Renal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Renal Cell Carcinoma (Kidney Cancer)
Keywords: Renal Cell Carcinoma
Partial nephrectomy
Radical nephrectomy
Preoperative planning
3D virtual model
Virtual Reality
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concordance score between actual performed surgery and surgical plan
timeFrame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Secondary outcomes:
measure: Intra-operative parameters: method of clamping
timeFrame: Perioperative
measure: Intraoperative parameters: blood loss
timeFrame: Perioperative
measure: Intraoperative parameters: clamping time
timeFrame: Perioperative
measure: Intraoperative parameters: opening of collecting system
timeFrame: Perioperative
measure: Intraoperative parameters: duration of surgery
timeFrame: Perioperative
measure: Post-operative parameters: renal function
timeFrame: Up to 1 month post-surgery
measure: Post-operative parameters: 30-day post-surgery complications
timeFrame: 30 days post-surgery
measure: Post-operative parameters: hospital stay
timeFrame: 30-days post-surgery
measure: Post-operative parameters: readmission (within 30 days)
timeFrame: 30-days post-surgery
measure: Post-operative parameters: clean resection margin
timeFrame: 30-days post-surgery
measure: Post-operative parameters:
timeFrame: 30-days post-surgery
measure: Understanding of anatomy - renal arteries
timeFrame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
measure: Understanding of anatomy - renal veins
timeFrame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
measure: Understanding of anatomy - collecting system
timeFrame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
measure: Understanding of anatomy - tumor
timeFrame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
measure: Understanding of anatomy - general anatomy
timeFrame: during preoperative planning (approximately 3 days before surgery)
Other outcomes:
measure: Demographic data - age
timeFrame: before surgery
measure: Demographic data - gender
timeFrame: before surgery
measure: Medical data - BMI
timeFrame: before surgery
measure: Medical data - ASA-score
timeFrame: before surgery
measure: Medical data - history of smoking
timeFrame: before surgery
measure: Medical data - comorbidities
timeFrame: before surgery
measure: Medical data - radiological TNM
timeFrame: before surgery
measure: Medical data - RENAL
timeFrame: before surgery
measure: Medical data - tumor side
timeFrame: before surgery
measure: Medical data - tumor size
timeFrame: before surgery
measure: Medical data - CT type
timeFrame: before surgery
measure: Medical data - surgeon
timeFrame: before surgery
Locations:
Study officials:
References: