Stentless Florence Robotic Intracorporeal Neobladder (FloRIN)

NCT05891535 | Unknown

• 1 other identifier: StentlessFloRIN
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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 (CCI), peri- and postoperative features including operative time, conversion rate, estimated blood loss (EBL), Visual Analogue Scale (VAS) pain intensity scale, length of hospital stay (LOS) early (≤30 days) and delayed (\>30 days) complications rate, and pathological data were thoroughly gathered. Follow-up schedule included blood analysis and CT scan performed three months after surgery, then every 6 months from the first to the third postoperative year, followed by annual imaging assessment according to individual risk profile, as postulated by the EAU guidelines. In case of newly diagnosed postoperative hydronephrosis, only patients with grade \> 2 or symptomatic were assessed as functional failure. All eligible patients were offered the possibility to undergo neoadjuvant cisplatin-based chemotherapy before RARC. Patients with non-muscle invasive bladder cancer, cN+ disease and those presenting with severe cardiovascular morbidity or high preoperative creatinine levels, strongly contraindicating cisplatin administration, underwent immediate radical cystectomy. The enhanced recovery after surgery protocol (ERAS) was regularly applied. Suitable patients underwent a nutritional assessment with a specific immune-nutrition, 7 days preoperatively.

Conditions

Perioperative Complication

Outcome Measures

Primary Outcomes (1)

• Mid term complications

  Mid term complications rate

  6 months

Secondary Outcomes (1)

• Preoperative complications

  7 days

Study Arms (2)

Stentless FloRIN

EXPERIMENTAL

Florence robotic Intra Corporeal Neobladder configuration was performed without the employement of Mono J ureteral catheters

Procedure: Robot assisted radical cystectomy without mono J ureteral stent placement

Stented FloRIN

ACTIVE COMPARATOR

Florence robotic Intra Corporeal Neobladder configuration was performed with the employement of Mono J ureteral catheters

Procedure: Robot assisted radical cystectomy with mono J ureteral stent placement

Interventions

Robot assisted radical cystectomy without mono J ureteral stent placement PROCEDURE

Robot assisted radical cystectomy with/without ureteral mono J stent placement during uretero-neobladder anastomosis

Stentless FloRIN

Robot assisted radical cystectomy with mono J ureteral stent placement PROCEDURE

Robot assisted radical cystectomy with/without ureteral mono J stent placement during uretero-neobladder anastomosis

Stented FloRIN

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosed Bladder Cancer with clinical stage T1-T4N0-N1M0
• Patients amenable to radical cystectomy with eligible to orthotopic neobladder reconfiguration curative intent and FloRIN reconfiguration were included.

You may not qualify if:

• Presence of one or multiple tumor metastases at preoperative staging
• Histopathological confirmation of bladder tumor at the level of prostatic urethra; - Treatment without curative intent (cT4b, salvage or palliative cystectomies)
• Presence of urethral stricture

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

Careggi hospital

Florence, 50134, Italy

RECRUITING

Related Publications (26)

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Study Officials

• Andrea Minervini, Prof.

  University of Florence

  STUDY DIRECTOR

Central Study Contacts

Andrea Minervini, Prof.

CONTACT

3386483466; andreamine@libero.it

Luca Lambertini, Dr

CONTACT

l.lambertini7@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 7, 2023
• Study Start: January 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)