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NCT Number: NCT06960174

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

Device

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.

Primary outcomes

  1. Concordance score between actual performed surgery and surgical plan

    Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery

    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

Secondary outcomes

  1. Intra-operative parameters: method of clamping

    Time frame: Perioperative

    Method of clamping (main renal artery / multiple arteries / no clamping / selective clamping)

  2. Intraoperative parameters: blood loss

    Time frame: Perioperative

    blood loss (value in ml)

  3. Intraoperative parameters: clamping time

    Time frame: Perioperative

    clamping time (value in mm:ss)

  4. Intraoperative parameters: opening of collecting system

    Time frame: Perioperative

    opening of collecting system (yes/no)

  5. Intraoperative parameters: duration of surgery

    Time frame: Perioperative

    duration of surgery (value in minutes)

  6. Post-operative parameters: renal function

    Time frame: Up to 1 month post-surgery

    Renal function (Creatinine level before surgery, 1 day post-surgery and 4 weeks post-surgery )

  7. Post-operative parameters: 30-day post-surgery complications

    Time frame: 30 days post-surgery

    30-day post-surgery complications ( Clavien Dindo score (Grade I / Grade II / Grade IIIa / Grade IIIb / Grade IVa / Grade IVb / Grade V) )

  8. Post-operative parameters: hospital stay

    Time frame: 30-days post-surgery

    hospital stay (days)

  9. Post-operative parameters: readmission (within 30 days)

    Time frame: 30-days post-surgery

    readmission (within 30 days) (yes/no)

  10. Post-operative parameters: clean resection margin

    Time frame: 30-days post-surgery

    clean resection margin (yes/no)

  11. Post-operative parameters:

    Time frame: 30-days post-surgery

    pathological TNM (TxNxMx)

  12. Understanding of anatomy - renal arteries

    Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery

    Understanding of renal arteries (Very poor / Poor / Moderate / Good / Excellent)

  13. Understanding of anatomy - renal veins

    Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery

    Understanding of renal veins (Very poor / Poor / Moderate / Good / Excellent)

  14. Understanding of anatomy - collecting system

    Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery

    Understanding of collecting system (Very poor / Poor / Moderate / Good / Excellent)

  15. Understanding of anatomy - tumor

    Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery

    Understanding of tumor anatomy (Very poor / Poor / Moderate / Good / Excellent)

  16. Understanding of anatomy - general anatomy

    Time frame: during preoperative planning (approximately 3 days before surgery)

    Confidence in understanding of general anatomy (Strongly disagree / Disagree / Neutral / Agree / Strongly agree)

Other outcomes

  1. Demographic data - age

    Time frame: before surgery

    Age (Years (at time of surgery) )

  2. Demographic data - gender

    Time frame: before surgery

    Gender (Male / Female )

  3. Medical data - BMI

    Time frame: before surgery

    BMI (Kg/m2)

  4. Medical data - ASA-score

    Time frame: before surgery

    ASA-score ( I / II / III / IV / V)

  5. Medical data - history of smoking

    Time frame: before surgery

    History of smoking (Packyears (or yes/no) )

  6. Medical data - comorbidities

    Time frame: before surgery

    Comorbidities (Charlson comorbidity index, 0-37))

  7. Medical data - radiological TNM

    Time frame: before surgery

    Radiological TNM classification (TxNxMx )

  8. Medical data - RENAL

    Time frame: before surgery

    RENAL score (4-12 a/p/h)

  9. Medical data - tumor side

    Time frame: before surgery

    Side of tumor(Left/right)

  10. Medical data - tumor size

    Time frame: before surgery

    Size of tumor (mm)

  11. Medical data - CT type

    Time frame: before surgery

    Type of CT (Contrast enhanced (which phases)/photon counting)

  12. Medical data - surgeon

    Time frame: before surgery

    Surgeon (Name / number )

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Trouw, BSc

CONTACT

[email protected]

0031616501192

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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