VR simulation study of robot-assisted partial nephrectomy (RAPN)

JRCT ID: jRCT1042220055

Registered date:17/08/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Renal tumor
• Date of first enrollment: 17/08/2022
• Target sample size: 80
• Study type: Interventional

Intervention(s)

[VR group]
1) The DICOM image created from the preoperative contrast-enhanced CT is read into the medical imaging software Ziostation, and the radiological technologist (co-researcher Ohashi) builds an STL (Stereolithography) file for each anatomical part. Patient personal information is de-anonymized at this point.
2) Create a patient-specific VR image by uploading these data to the medical VR creation site Holoeyes (https://xr.holoeyes.jp/).
3) Using immersive VR goggles, place a virtual port line from the positional relationship of the bone, renal parenchyma, renal tumor, resection margin, renal artery and vein, renal pelvis, etc. in the VR space, and place the rib and the point where this line passes through the skin. Measure the distance from the ilium in VR space.
4) Under general anesthesia, mark the position of the skin port measured by VR on the body. Using that position as a guide, construct a port. At this time, if the operator determines that the port position determined by the VR is not appropriate in the actual surgical field, the port position determined by the VR is not always adhered to. However, in this case as well, the VR group is used because the port is created by grasping the positional relationship of the tumor and the anatomical organs of each patient using VR.

[Control group]
1) Perform RAPN under general anesthesia with reference only to preoperative contrast-enhanced CT image information. As for the port position, select the most suitable site based on the operator's experience.

Outcome(s)

• Primary Outcome: Trifecta achievement rate ((1) Negative margins, (2) WIT within 25 minutes, (3) No perioperative complications)

Secondary Outcome

Change in Cre, change in hemoglobin, change in CRP, change in urinary red blood cell count/white blood cell count
Comparison of operation time, console time, console time, time from robot operation start to artery/tumor identification, and bleeding volume
Trends in responses from surgeons using questionnaire items regarding the usefulness of VR

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

(1) Patients diagnosed with cT1 renal tumor (tumor diameter less than 70mm) considered suitable for RAPN surgery
(2) Age between 20 and 80 on the date of obtaining consent
(3) ECOG Performance Status (PS) is 0, 1 or less
(4) Patients who have given informed consent in writing

Exclude criteria

(1) Patients for whom preoperative contrast-enhanced CT is difficult due to allergies or decreased renal function
(2) In addition, patients who are judged to be inappropriate as research subjects by the research director (co-investigator)

Related Information

• Primary Sponsor: Okada Atsushi
• Source(s) of Monetary Support: Japanese Society of Endourology and Robotics