Virtual Renality: Assessing the Impact of Virtual Reality on Preoperative Planning in Renal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Concordance score between actual performed surgery and surgical plan
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected RCC and candidate for (partial) nephrectomy
- •Signed informed consent
排除标准
- •Patients who are not approved to undergo surgery (due to comorbidities or their overall health condition)
- •Patients who are unable to give informed consent
结局指标
主要结局
Concordance score between actual performed surgery and surgical plan
时间窗: 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
次要结局
- 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)
- Post-operative parameters: renal function(Up to 1 month post-surgery)
- Post-operative parameters: 30-day post-surgery complications(30 days post-surgery)
- Post-operative parameters: hospital stay(30-days post-surgery)
- Post-operative parameters: readmission (within 30 days)(30-days post-surgery)
- Post-operative parameters: clean resection margin(30-days post-surgery)
- Post-operative parameters:(30-days post-surgery)
- Understanding of anatomy - renal arteries(during preoperative planning (approximately 3 days before surgery) and immediately after surgery)
- Understanding of anatomy - renal veins(during preoperative planning (approximately 3 days before surgery) and immediately after surgery)
- Understanding of anatomy - collecting system(during preoperative planning (approximately 3 days before surgery) and immediately after surgery)
- Understanding of anatomy - tumor(during preoperative planning (approximately 3 days before surgery) and immediately after surgery)
- Understanding of anatomy - general anatomy(during preoperative planning (approximately 3 days before surgery))
研究者
Hille Torenvlied
Principal Investigator
St. Antonius Hospital