Robotic surgery for bladder cancer using a stentless technique
Stentless Florence Robotic Intracorporeal Neobladder (FloRIN)
This study is testing a new robotic surgery technique for bladder cancer that doesn't use stents to see if it works as well as the standard method for patients needing bladder removal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Sex | All |
| Sponsor | University of Florence Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Florence) |
| Trial ID | NCT05891535 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the perioperative and mid-term functional outcomes of a stentless robotic intracorporeal neobladder reconfiguration technique, known as FloRIN, compared to the standard method that involves ureteral mono J stent placement. The study includes patients diagnosed with bladder cancer who are eligible for radical cystectomy and aims to gather clinical and surgical data from procedures performed at a single institution. The surgical approach utilizes the Da Vinci Si robotic system and involves a specific technique for creating the neobladder. The trial is designed as a randomized, non-inferiority study to evaluate the effectiveness of the new technique.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with bladder cancer at clinical stages T1-T4N0-N1M0 who are eligible for radical cystectomy with curative intent.
Not a fit: Patients with metastatic bladder cancer or those requiring palliative treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced complications for patients undergoing bladder cancer surgery.
How similar studies have performed: While the specific stentless FloRIN technique may be novel, similar robotic surgical approaches have shown promise in improving outcomes in bladder cancer surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Florence
- Careggi hospital — Florence, Italy (Recruiting)
Study contacts
- Study coordinator: Andrea Minervini, Prof.
- Email: andreamine@libero.it
- Phone: 3386483466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.