A Phase 3 Prospective Randomized Trial to Evaluate the Impact of Augmented Reality During Robot-assisted Radical Prostatectomy on the Rates of Postoperative Surgical Margins: A Clinical Trial Protocol

Gennaro Musi; Francesco A Mistretta; Ottavio de Cobelli; Andrea Bellin; Gianluca Gaetano Vago; Gabriella Pravettoni; Danilo Bottero; Mattia Luca Piccinelli; Matteo Ferro; Mariia Ivanova; Giuseppe Petralia; Giulia Marvaso; Barbara A Jereczek-Fossa; Vincenzo Bagnardi; Giuseppe Renne; Nicola Fusco; Stefano Luzzago

doi:10.1016/j.euros.2024.01.006

A Phase 3 Prospective Randomized Trial to Evaluate the Impact of Augmented Reality During Robot-assisted Radical Prostatectomy on the Rates of Postoperative Surgical Margins: A Clinical Trial Protocol

Eur Urol Open Sci. 2024 Feb 3:61:1-9. doi: 10.1016/j.euros.2024.01.006. eCollection 2024 Mar.

Authors

Gennaro Musi^{1

2}, Francesco A Mistretta^{1

2}, Ottavio de Cobelli^{1

2}, Andrea Bellin¹, Gianluca Gaetano Vago², Gabriella Pravettoni^{2

3}, Danilo Bottero¹, Mattia Luca Piccinelli¹, Matteo Ferro¹, Mariia Ivanova⁴, Giuseppe Petralia^{2

5}, Giulia Marvaso^{2

6}, Barbara A Jereczek-Fossa^{2

6}, Vincenzo Bagnardi⁷, Giuseppe Renne⁴, Nicola Fusco^{2

4}, Stefano Luzzago^{1

2}

Affiliations

¹ Department of Urology, European Institute of Oncology (IEO) IRCCS, Milan, Italy.
² Department of Oncology and Hematology-Oncology, University of Milan, Milan, Italy.
³ Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.
⁴ Division of Pathology, IEO European Institute of Oncology, IRCCS, Milan, Italy.
⁵ Precision Imaging and Research Unit, Department of Medical Imaging and Radiation Sciences, European Institute of Oncology (IEO), IRCCS, Milan, Italy.
⁶ Division of Radiotherapy, IEO European Institute of Oncology, IRCCS, Milan, Italy.
⁷ Department of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy.

Abstract

We designed a phase 3, prospective, randomized trial to evaluate the impact of augmented reality and augmented reality frozen section analysis in reducing the rates of positive surgical margins after robot-assisted radical prostatectomy.