Mixed Reality Technology in Laparoscopic Partial Nephrectomy

St. Petersburg State Pavlov Medical University

Status: Completed

Conditions: Kidney Tumor

Treatments: Procedure: mixed reality technology in laparoscopic partial nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05015179

38/124-25

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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47 participants in 2 patient groups

Control

No Intervention group

Description:

Laparoscopic partial nephrectomy is performed with an intraoperative ultrasound (US) control

Experimental

Experimental group

Description:

Underwent Laparoscopic partial nephrectomy with the aid of the mixed reality model

Treatment:

Procedure: mixed reality technology in laparoscopic partial nephrectomy