Mixed Reality Technology in Laparoscopic Partial Nephrectomy

NCT05015179 | Completed

• 1 other identifier: 38/124-25
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Tumor

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control

NO INTERVENTION

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

Experimental

EXPERIMENTAL

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

Procedure: mixed reality technology in laparoscopic partial nephrectomy

Interventions

mixed reality technology in laparoscopic partial nephrectomy PROCEDURE

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able to sign informed consent
• had T1a renal tumors amenable to LPN

You may not qualify if:

• were unwilling to participate

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead
• Saint Petersburg State University, Russia: collaborator

Study Sites (1)

Saint Petersburg State University Hospital

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2021
• First Posted: August 20, 2021
• Study Start: June 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

RU (1)