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.
NCT Number: NCT06960174
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: Perioperative
Method of clamping (main renal artery / multiple arteries / no clamping / selective clamping)
Time frame: Perioperative
blood loss (value in ml)
Time frame: Perioperative
clamping time (value in mm:ss)
Time frame: Perioperative
opening of collecting system (yes/no)
Time frame: Perioperative
duration of surgery (value in minutes)
Time frame: Up to 1 month post-surgery
Renal function (Creatinine level before surgery, 1 day post-surgery and 4 weeks post-surgery )
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) )
Time frame: 30-days post-surgery
hospital stay (days)
Time frame: 30-days post-surgery
readmission (within 30 days) (yes/no)
Time frame: 30-days post-surgery
clean resection margin (yes/no)
Time frame: 30-days post-surgery
pathological TNM (TxNxMx)
Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Understanding of renal arteries (Very poor / Poor / Moderate / Good / Excellent)
Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Understanding of renal veins (Very poor / Poor / Moderate / Good / Excellent)
Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Understanding of collecting system (Very poor / Poor / Moderate / Good / Excellent)
Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Understanding of tumor anatomy (Very poor / Poor / Moderate / Good / Excellent)
Time frame: during preoperative planning (approximately 3 days before surgery)
Confidence in understanding of general anatomy (Strongly disagree / Disagree / Neutral / Agree / Strongly agree)
Time frame: before surgery
Age (Years (at time of surgery) )
Time frame: before surgery
Gender (Male / Female )
Time frame: before surgery
BMI (Kg/m2)
Time frame: before surgery
ASA-score ( I / II / III / IV / V)
Time frame: before surgery
History of smoking (Packyears (or yes/no) )
Time frame: before surgery
Comorbidities (Charlson comorbidity index, 0-37))
Time frame: before surgery
Radiological TNM classification (TxNxMx )
Time frame: before surgery
RENAL score (4-12 a/p/h)
Time frame: before surgery
Side of tumor(Left/right)
Time frame: before surgery
Size of tumor (mm)
Time frame: before surgery
Type of CT (Contrast enhanced (which phases)/photon counting)
Time frame: before surgery
Surgeon (Name / number )
Contact information is provided by the study sponsor or research team.
St. Antonius Hospital
Other
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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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