Stentless florence robotic intracorporeal neobladder (FloRIN), a feasibility prospective randomized clinical trial

Luca Lambertini; Fabrizio Di Maida; Anna Cadenar; Samuele Nardoni; Antonio Andrea Grosso; Francesca Valastro; Pietro Spinelli; Riccardo Fantechi; Agostino Tuccio; Gianni Vittori; Andrea Mari; Lorenzo Masieri; Andrea Minervini

doi:10.1016/j.ejso.2023.107259

Stentless florence robotic intracorporeal neobladder (FloRIN), a feasibility prospective randomized clinical trial

Eur J Surg Oncol. 2024 Jan;50(1):107259. doi: 10.1016/j.ejso.2023.107259. Epub 2023 Nov 8.

Affiliations

¹ Department of Experimental and Clinical Medicine, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital, Florence, Italy.
² Department of Experimental and Clinical Medicine, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital, Florence, Italy. Electronic address: andrea.minervini@unifi.it.

PMID: 38011784
DOI: 10.1016/j.ejso.2023.107259

Abstract

Introduction: Aim of the study was to evaluate perioperative, postoperative and mid-term functional outcomes of Florence intracorporeal neobladder (FloRIN) configuration technique performed with stentless procedure.

Materials and methods: This single institution randomized 1:1 prospective series included consecutive patients treated with Robot-Assisted Radical Cystectomy (RARC) and FloRIN reconfiguration from January 2021 to February 2022. Postoperative complications were graded according to Clavien Dindo classification and divided in early (<30 days from discharge) and delayed (>30 days).

Results: Overall, 63 patients were included in the analysis. Among these 32 (50.8 %) were treated with RARC + stentless FloRIN while 31 (49.2 %) underwent stent placement procedure. No differences were found in terms of baseline characteristics between the two groups. Stentless procedure was associated with significant shorter console time 328 vs 374 min (p = 0.04) and lower estimated blood loss (EBL) 330 vs 350 ml (p = 0.04) comparing to stent group. As regards perioperative features, no significant differences were recorded in terms of canalization (p = 0.58) and time to drainage removal (p = 0.11) while a shorter length of hospital stay was found in case of stentless procedure (p = 0.04). Early postoperative complications Clavien ≥ 3a occurred in 9.3 % and 12.9 % of patients while delayed major complications were recorded in the 3.1 % and 9.6 % of patients treated with stentless and stent FloRIN, respectively (p = 0.09). As regards the mid-term functional outcomes, no differences were found in terms of kidney function loss in both 3rd and 6th month assessment (p = 0.13 and p = 0.14, respectively).

Conclusions: In conclusion, Stentless FloRIN is a feasible and safe IntraCorporeal Neobladder technique, as confirmed by the worthy functional and perioperative outcomes achieved in comparison with the standard FloRIN ureteral management strategy.

Keywords: Bladder cancer; IntraCorporeal neobladder; Robot assisted radical cystectomy; Stentless; Ureteral stent.

Publication types

Randomized Controlled Trial

MeSH terms

Cystectomy / methods
Feasibility Studies
Humans
Postoperative Complications / etiology
Robotic Surgical Procedures* / methods
Robotics*
Treatment Outcome
Urinary Bladder Neoplasms* / complications
Urinary Bladder Neoplasms* / surgery
Urinary Diversion* / methods