Stentless Florence Robotic Intracorporeal Neobladder (FloRIN)

Sponsor

University of Florence (Other)

Overall Status

Recruiting

CT.gov ID

NCT05891535

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perioperative Complication	Procedure: Robot assisted radical cystectomy without mono J ureteral stent placement Procedure: Robot assisted radical cystectomy with mono J ureteral stent placement	N/A

Detailed Description

Surgical technique All robotic surgical procedures were performed by a single highly experienced robotic surgeon (AM) alternated with the other fellow-members. The Da Vinci Si system, (Intuitive Surgical, Sunnyvale, CA, USA), in a four-arm conﬁguration with a 0/30° laparoscope was used for all cases. As previously described (4), patients are positioned in 30° Trendelenburg with a standard six-port transperitoneal approach for the demolitive part and then reduced to 20° to facilitate bowel handling and urethro-neobladder anastomosis. After the isolation of 45-50 cm of ileum, the urethro-ileal anastomosis is performed obtaining an asymmetrical 'U'-shape (25-30 cm distally and 20 cm proximally to anastomosis). Ileum is then sectioned by endo- GIA 60 mm Echelon Powered Endopath Stapler (Ethicon Inc., Cincinnati, OH, USA) and the intestinal continuity is then restored with an intracorporeal side-to-side anastomosis with one longitudinal fire. The two transversal holes are closed by a double layer 3-0 Stratafix running suture. The asymmetrical 'U'-shape segment is then detubularized and the posterior plate is reconfigured as an "Γ", by suturing the span of the arms of the 'U' aligned in parallel, and by placing the extending portion of the loop distally to the right, forming the short arm of the "Γ". Neobladder neck configuration was performed by suturing a tract of 2-5 cm longitudinally from the 12 o'clock position of the anastomosis. Then, the posterior plate was folded anteriorly, distal to proximally, roughly 5 cm right from the proximal edge of the posterior closure with the goal of creating two symmetrical segments.

Ureteral reimplantation After a careful isolation of the ureters avoiding iatrogenic blood supply damages, the ureteric stumps were sectioned and adequately spatulated. Bilateral ureteral reimplantation was then performed orthotopically and directly with no anti-reflux mechanisms on the lateral side of each anterior segment with mucosa-mucosa inverted sutures. In case of stentless procedure the anastomosis was performed directly while mono J ureteral catheters were employed in case of stent placement. The anterior plate was therefore closed by an "∧" -shaped suture. Both mono J stents were passed through the closing of the two anterior plates in the stent group.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Stentless Florence Robotic Intracorporeal Neobladder (FloRIN)

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stentless FloRIN 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 Robot assisted radical cystectomy with/without ureteral mono J stent placement during uretero-neobladder anastomosis
Active Comparator: Stented FloRIN 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 Robot assisted radical cystectomy with/without ureteral mono J stent placement during uretero-neobladder anastomosis

Arm

Intervention/Treatment

Experimental: Stentless FloRIN

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

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

Active Comparator: Stented FloRIN

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

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

Outcome Measures

Primary Outcome Measures

Mid term complications [6 months]
Mid term complications rate

Secondary Outcome Measures

Preoperative complications [7 days]
Perioperative complications rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Careggi hospital	Florence		Italy	50134

Sponsors and Collaborators

University of Florence

Investigators

Study Director: Andrea Minervini, Prof., University of Florence

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Luca Lambertini, Professor, University of Florence

ClinicalTrials.gov Identifier:

NCT05891535

Other Study ID Numbers:

StentlessFloRIN

First Posted:

Jun 7, 2023

Last Update Posted:

Jun 7, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 7, 2023