Robot-assisted Partial Nephrectomy With and Without Mixed Reality (REALITATEM Study)

Kidney cancer has had a raising diagnostic incidence and partial nephrectomy (PN) is the standard of care for renal masses stage cT1a and a possible treatment choice for cT1b/T2; PN may be associated to a variety of tools, such as three-dimensional (3D) models, which can be used as printed models or through VR (virtual reality) and/or AR (augmented reality). Virtual reality is defined as an artificial 3D visual environment and AR, as virtual objects superimposed on the real world; mixed reality (MIXREAL) is the association between VR and AR. The first clinical experience using AR in a PN was in 2008, and since then, clinical trials of 3D assisted minimally invasive PN have been developed, such as the first trial evaluating both AR and VR in videolaparoscopic PN, a prospective cohort, and the first randomized clinical trial evaluating 3D model in robot assisted PN (RAPN), but using only VR; posteriorly, Porpiglia et al. and Li et al. published clinical trials of RAPN using AR. The investigators aimed to establish the improvements that use of MIXREAL can provide in perioperatory and functional outcomes of RAPN. Although previous studies have been showing positive results on behalf of 3D virtual models, besides this being the first study in Latin America to employ MIXREAL in minimally invasive PN, it is the first randomized clinical trial to employ both AR and VR in the context of RAPN. To analyze the efficacy of MIXREAL, the investigators intended to allocate forty-five patients with renal lesions to RAPN with, Realitatem Group (RG), or without, Control Group (CG), use of MIXREAL.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* patients above 18 years old with solid renal masses or complex renal cysts Bosniak III/IV requiring partial nephrectomy

Exclusion Criteria:

* solid renal masses or complex renal cysts Bosniak III/IV with initial indication of radical nephrectomy

• RESULTPalumbo C, Pecoraro A, Knipper S, Rosiello G, Luzzago S, Deuker M, Tian Z, Shariat SF, Simeone C, Briganti A, Saad F, Berruti A, Antonelli A, Karakiewicz PI. Contemporary Age-adjusted Incidence and Mortality Rates of Renal Cell Carcinoma: Analysis According to Gender, Race, Stage, Grade, and Histology. Eur Urol Focus. 2021 May;7(3):644-652. doi: 10.1016/j.euf.2020.05.003. Epub 2020 May 23. PMID 32456993
• RESULTBukavina L, Bensalah K, Bray F, Carlo M, Challacombe B, Karam JA, Kassouf W, Mitchell T, Montironi R, O'Brien T, Panebianco V, Scelo G, Shuch B, van Poppel H, Blosser CD, Psutka SP. Epidemiology of Renal Cell Carcinoma: 2022 Update. Eur Urol. 2022 Nov;82(5):529-542. doi: 10.1016/j.eururo.2022.08.019. Epub 2022 Sep 10. PMID 36100483
• RESULTMotzer RJ, Jonasch E, Boyle S, Carlo MI, Manley B, Agarwal N, Alva A, Beckermann K, Choueiri TK, Costello BA, Derweesh IH, Desai A, George S, Gore JL, Haas N, Hancock SL, Kyriakopoulos C, Lam ET, Lau C, Lewis B, Madoff DC, McCreery B, Michaelson MD, Mortazavi A, Nandagopal L, Pierorazio PM, Plimack ER, Ponsky L, Ramalingam S, Shuch B, Smith ZL, Somer B, Sosman J, Dwyer MA, Motter AD. NCCN Guidelines Insights: Kidney Cancer, Version 1.2021. J Natl Compr Canc Netw. 2020 Sep;18(9):1160-1170. doi: 10.6004/jnccn.2020.0043. PMID 32886895
• RESULTWake N, Nussbaum JE, Elias MI, Nikas CV, Bjurlin MA. 3D Printing, Augmented Reality, and Virtual Reality for the Assessment and Management of Kidney and Prostate Cancer: A Systematic Review. Urology. 2020 Sep;143:20-32. doi: 10.1016/j.urology.2020.03.066. Epub 2020 Jun 12. PMID 32535076
• RESULTDetmer FJ, Hettig J, Schindele D, Schostak M, Hansen C. Virtual and Augmented Reality Systems for Renal Interventions: A Systematic Review. IEEE Rev Biomed Eng. 2017;10:78-94. doi: 10.1109/RBME.2017.2749527. Epub 2017 Sep 6. PMID 28885161
• RESULTUkimura O, Gill IS. Imaging-assisted endoscopic surgery: Cleveland Clinic experience. J Endourol. 2008 Apr;22(4):803-10. doi: 10.1089/end.2007.9823.