Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05891535
Status:
RECRUITING
Last Update Posted:
2023-06-07
First Post:
2023-05-24
Brief Title:
Stentless Florence Robotic Intracorporeal Neobladder FloRIN
Sponsor:
University of Florence
Organization:
University of Florence
Study Overview
Official Title:
Stentless Florence Robotic Intracorporeal Neobladder FloRIN
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 11 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
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 11 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 11 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
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 030 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 oclock 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None