Mixed Reality Technology in Laparoscopic Partial Nephrectomy

NCT ID: NCT05015179

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental

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

Group Type: EXPERIMENTAL

mixed reality technology in laparoscopic partial nephrectomy

Intervention Type: 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

Interventions

mixed reality technology in laparoscopic partial nephrectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• were unwilling to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Petersburg State University, Russia

OTHER

Sponsor Role: collaborator

St. Petersburg State Pavlov Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Saint Petersburg State University Hospital

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

38/124-25

Identifier Type: -

Identifier Source: org_study_id