Mixed Reality Technology in Laparoscopic Partial Nephrectomy

Study Overview
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Brief Summary
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The aim of our study was: a) to evaluate the usefulness of the MR model for renal pedicle exposure and identification of the tumor's exact location during LPN, and b) to evaluate the subjective utility of the MR model as an intraoperative reference tool. Investigators prospectively enrolled 47 patients with LPN between June 2020 and February 2021. Patients were randomly assigned into two groups: the control group (24 patients), who underwent operation with an intraoperative ultrasound (US) control and the experimental group (23 patients), who underwent operation with the aid of the MR model. Randomization was performed using a computerized randomization program and sealed envelopes. Patients were included in the study if they were 18 years of age or older, were able to sign informed consent, and had T1a renal tumors amenable to LPN. Patients were excluded if they were unwilling to participate or did not meet the inclusion criteria. For each patient, investigators prospectively collected demographic data including age, body mass index, clinical tumor size, side, location, and complexity score according to the PADUA scoring system; perioperative data (including time for renal pedicle exposure and time for renal tumor detection and duration of ischemia); pathological data; data on postoperative functional outcome and complications, classified according to the Clavien-Dindo system.

Official Title
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Using Mixed Reality Technology to Facilitate Laparoscopic Partial Nephrectomy

Conditions
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Kidney Tumor

Intervention / Treatment
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* Procedure: mixed reality technology in laparoscopic partial nephrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: able to sign informed consent had T1a renal tumors amenable to LPN Exclusion Criteria: were unwilling to participate did not meet the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Laparoscopic partial nephrectomy is performed with an intraoperative ultrasound (US) control | |
| Experimental: Experimental<br>Underwent Laparoscopic partial nephrectomy with the aid of the mixed reality model | Procedure: mixed reality technology in laparoscopic partial nephrectomy<br>* All patients undergo contrast-enhanced computed tomography before surgery. DICOM files are converted to a 3D model. This model is then sent to HoloLens 2 smart glasses using HLOIA software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time required to expose renal pedicle during laparoscopic partial nephrectomy |  | during operation completion, min | 
| time required to get from renal pedicle to tumor during laparoscopic partial nephrectomy |  | during operation completion, min |