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

NCT06960174 | Not Yet Recruiting

• 1 other identifier: NL-009626
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Cell Carcinoma (Kidney Cancer)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (16)

• Intra-operative parameters: method of clamping

  Perioperative

• Intraoperative parameters: blood loss

  Perioperative

• Intraoperative parameters: clamping time

  Perioperative

• Intraoperative parameters: opening of collecting system

  Perioperative

• Intraoperative parameters: duration of surgery

  Perioperative

Other Outcomes (12)

• Demographic data - age

  before surgery

• Demographic data - gender

  before surgery

• Medical data - BMI

  before surgery

Study Arms (2)

Preoperative planning based on CT

NO INTERVENTION

For the control group the preoperative planning will be according to the current standard of care using only the CT scan.

Preoperative planning based on CT + VR

EXPERIMENTAL

For the intervention group, the urologist will review a 3D virtual model of the renal anatomy in addition to the CT scan during preoperative planning

Device: Virtual reality

Interventions

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.

Preoperative planning based on CT + VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected RCC and candidate for (partial) nephrectomy
• Signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

• St. Antonius Hospital: lead

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Emma Trouw, BSc

CONTACT

0031616501192; e.trouw@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 7, 2025
• Study Start: June 2, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-04