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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Virtual 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.

Первичные конечные точки

• Concordance score between actual performed surgery and surgical plan [Срок оценки: during preoperative planning (approximately 3 days before surgery) and immediately after surgery]

Вторичные конечные точки (12)

• Intra-operative parameters: method of clamping [Срок оценки: Perioperative]
• Intraoperative parameters: blood loss [Срок оценки: Perioperative]
• Intraoperative parameters: clamping time [Срок оценки: Perioperative]
• Intraoperative parameters: opening of collecting system [Срок оценки: Perioperative]
• Intraoperative parameters: duration of surgery [Срок оценки: Perioperative]
• Post-operative parameters: renal function [Срок оценки: Up to 1 month post-surgery]
• Post-operative parameters: 30-day post-surgery complications [Срок оценки: 30 days post-surgery]
• Post-operative parameters: hospital stay [Срок оценки: 30-days post-surgery]
• Post-operative parameters: readmission (within 30 days) [Срок оценки: 30-days post-surgery]
• Post-operative parameters: clean resection margin [Срок оценки: 30-days post-surgery]
• Post-operative parameters: [Срок оценки: 30-days post-surgery]
• Understanding of anatomy - renal arteries [Срок оценки: during preoperative planning (approximately 3 days before surgery) and immediately after surgery]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06960174 · NL-009626

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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