Mixed Reality Technology in Laparoscopic Partial Nephrectomy

Not Applicable

Completed

• Conditions: Kidney Tumor
• Interventions: Procedure: mixed reality technology in laparoscopic partial nephrectomy

• Registration Number: NCT05015179
• Lead Sponsor: St. Petersburg State Pavlov Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-03-01
• Status Verified: 2021-08
• Study First Submitted: 2021-08-07
• Study First Submitted QC: 2021-08-14
• Last Update Submitted: 2021-08-14
• Study First Posted: 2021-08-20
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	mixed reality technology in laparoscopic partial nephrectomy	Underwent Laparoscopic partial nephrectomy with the aid of the mixed reality model

Primary Outcome Measures

Name	Time	Method
time required to get from renal pedicle to tumor during laparoscopic partial nephrectomy	during operation completion, min
time required to expose renal pedicle during laparoscopic partial nephrectomy	during operation completion, min

Trial Locations

Locations (1)

Saint Petersburg State University Hospital; 🇷🇺 Saint Petersburg, Russian Federation