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Stentless Florence Robotic Intracorporeal Neobladder (FloRIN)

NCT05891535 · University of Florence · Updated 7 June 2023

What is being tested
Robot assisted radical cystectomy without mono J ureteral stent placement; Robot assisted radical cystectomy with mono J ureteral stent placement
For
Perioperative Complication
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages Not stated. About 63 people. The full rules are on the registry page.
Where
Italy
When
Starts or started 1 Jan 2021, ends 1 Jan 2024. Registered 7 June 2023.
Results
None posted yet.

In the researchers' words

Objective: To investigate perioperative and mid-term functional outcomes of stentless FloRIN reconfiguration as compared to standard technique performed with ureteral mono J placement. Patient and dataset Clinical and surgical data of all consecutive patients treated at our Institution from January 2021 to February 2022 with RARC, lymph node dissection (LND) and FloRIN reconfiguration were gathered in this single institution randomized 1:1 prospective series. All patients with clinical stage T1-T4N0-N1M0 amenable to radical cystectomy with curative intent and FloRIN reconfiguration were included. The sample size for a non-inferiority trial was calculated for different endpoints. Preoperative work-up included chest and abdomen contrast-enhanced computed tomography (CT) scan. Main exclusion criteria were: 1) presence of one or multiple tumor metastases at preoperative staging; 2) histopathological confirmation of bladder tumor at the level of prostatic urethra; 3) treatment without curative intent (cT4b, salvage or palliative cystectomies); 4) presence of urethral stricture. After preliminary multidisciplinary evaluation, patients were randomly assigned with 1:1 ratio to the mono-J stent placement or the stentless group. For the present study, only patients with a minimum 6 month-follow up were evaluated. Patient demographics, including ASA score and Charlson Comorbidity Index…
ClinicalTrials.gov, NCT05891535

Sites

  • Careggi hospitalFlorence, Italy