Perioperative ComplicationNCT05891535
Stentless Florence Robotic Intracorporeal Neobladder (FloRIN)
A study testing Robot assisted radical cystectomy without mono J ureteral stent placement and Robot assisted radical cystectomy with mono J ureteral stent placement in people with Perioperative Complication, run by University of Florence at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perioperative Complication
- What is being tested?
- Robot assisted radical cystectomy without mono J ureteral stent placement and Robot assisted radical cystectomy with mono J ureteral stent placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Luca Lambertini, Dr contact
Italy1 site, 1 recruiting
- Recruiting
Careggi hospital
Florence, 50134
Luca Lambertini, Dr, 3386483466, l.lambertini7@gmail.com
Luca Lambertini, Dr, 3386483466, luca.lambertni@unifi.it
About this study
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.
Read the 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.
- Conditions
- Perioperative Complication
- Being tested
- Robot assisted radical cystectomy without mono J ureteral stent placement, Robot assisted radical cystectomy with mono J ureteral stent placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted radical cystectomy without mono J ureteral stent placementProcedure or surgery
Robot assisted radical cystectomy with/without ureteral mono J stent placement during uretero-neobladder anastomosis
Robot assisted radical cystectomy with mono J ureteral stent placementProcedure or surgery
Robot assisted radical cystectomy with/without ureteral mono J stent placement during uretero-neobladder anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Stentless FloRIN | Experimental | Florence robotic Intra Corporeal Neobladder configuration was performed without the employement of Mono J ureteral catheters Receives: 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 Receives: Procedure: Robot assisted radical cystectomy with mono J ureteral stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid term complications
Mid term complications rate
Measured: 6 months
Secondary outcomes (1)
Preoperative complications
Perioperative complications rate
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Lambertini, University of Florence
- Investigators
- Andrea Minervini, Prof., Study director, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891535
- Sponsor's protocol ID
- StentlessFloRIN
- Status last verified
- Jun 2023
- First submitted
- 24 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmed K, Khan SA, Hayn MH, Agarwal PK, Badani KK, Balbay MD, Castle EP, Dasgupta P, Ghavamian R, Guru KA, Hemal AK, Hollenbeck BK, Kibel AS, Menon M, Mottrie A, Nepple K, Pattaras JG, Peabody JO, Poulakis V, Pruthi RS, Redorta JP, Rha KH, Richstone L, Saar M, Scherr DS, Siemer S, Stoeckle M, Wallen EM, Weizer AZ, Wiklund P, Wilson T, Woods M, Khan MS. Analysis of intracorporeal compared with extracorporeal urinary diversion after robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. Eur Urol. 2014 Feb;65(2):340-7. doi: 10.1016/j.eururo.2013.09.042. Epub 2013 Oct 9.
PubMed 24183419Dell'Oglio P, Mazzone E, Lambert E, Vollemaere J, Goossens M, Larcher A, Van Der Jeugt J, Devos G, Poelaert F, Uvin P, Collins J, De Naeyer G, Schatteman P, D'Hondt F, Mottrie A. The Effect of Surgical Experience on Perioperative and Oncological Outcomes After Robot-assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Evidence from a Referral Centre with Extensive Experience in Robotic Surgery. Eur Urol Focus. 2021 Mar;7(2):352-358. doi: 10.1016/j.euf.2020.01.016. Epub 2020 Feb 13.
PubMed 32061537McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration; Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8.
PubMed 19782876Minervini A, Vanacore D, Vittori G, Milanesi M, Tuccio A, Siena G, Campi R, Mari A, Gavazzi A, Carini M. Florence robotic intracorporeal neobladder (FloRIN): a new reconfiguration strategy developed following the IDEAL guidelines. BJU Int. 2018 Feb;121(2):313-317. doi: 10.1111/bju.14077. Epub 2017 Dec 11.
PubMed 29140596Di Maida F, Grosso AA, Tasso G, Gemma L, Lambertini L, Nardoni S, Mari A, Tuccio A, Vittori G, Masieri L, Minervini A. Robot assisted radical cystectomy with Florence Robotic Intracorporeal Neobladder (FloRIN): Functional and urodynamic features compared with a contemporary series of open Vescica Ileale Padovana (VIP). Eur J Surg Oncol. 2022 Aug;48(8):1854-1861. doi: 10.1016/j.ejso.2022.04.007. Epub 2022 Apr 20.
PubMed 35484043Minervini A, Di Maida F, Tasso G, Mari A, Bossa R, Sforza S, Grosso AA, Tellini R, Vittori G, Siena G, Tuccio A, Masieri L, Carini M. Robot assisted radical cystectomy with Florence robotic intracorporeal neobladder (FloRIN): Analysis of survival and functional outcomes after first 100 consecutive patients upon accomplishment of phase 3 IDEAL framework. Eur J Surg Oncol. 2021 Oct;47(10):2651-2657. doi: 10.1016/j.ejso.2021.05.007. Epub 2021 May 15.
PubMed 34023169Beano H, He J, Hensel C, Worrilow W, Townsend W, Gaston K, Clark PE, Riggs S. Safety of decreasing ureteral stent duration following radical cystectomy. World J Urol. 2021 Feb;39(2):473-479. doi: 10.1007/s00345-020-03191-2. Epub 2020 Apr 17.
PubMed 32303901Scotland KB, Lo J, Grgic T, Lange D. Ureteral stent-associated infection and sepsis: pathogenesis and prevention: a review. Biofouling. 2019 Jan;35(1):117-127. doi: 10.1080/08927014.2018.1562549. Epub 2019 Feb 8.
PubMed 30732463Peng YL, Ning K, Wu ZS, Li ZY, Deng MH, Xiong LB, Yu CP, Zhang ZL, Liu ZW, Lu HM, Zhou FJ. Ureteral stents cannot decrease the incidence of ureteroileal anastomotic stricture and leakage: A systematic review and meta-analysis. Int J Surg. 2021 Sep;93:106058. doi: 10.1016/j.ijsu.2021.106058. Epub 2021 Aug 18.
PubMed 34416355Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716Joyce CR, Zutshi DW, Hrubes V, Mason RM. Comparison of fixed interval and visual analogue scales for rating chronic pain. Eur J Clin Pharmacol. 1975 Aug 14;8(6):415-20. doi: 10.1007/BF00562315.
PubMed 1233242Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Witjes JA, Bruins HM, Cathomas R, Comperat EM, Cowan NC, Gakis G, Hernandez V, Linares Espinos E, Lorch A, Neuzillet Y, Rouanne M, Thalmann GN, Veskimae E, Ribal MJ, van der Heijden AG. European Association of Urology Guidelines on Muscle-invasive and Metastatic Bladder Cancer: Summary of the 2020 Guidelines. Eur Urol. 2021 Jan;79(1):82-104. doi: 10.1016/j.eururo.2020.03.055. Epub 2020 Apr 29.
PubMed 32360052Stangl-Kremser J, Lambertini L, Di Maida F, Martinez-Fundichely A, Ferro M, Pradere B, Soria F, Albisinni S, Wu Z, Del Giudice F, Cacciamani GE, Valerio M, Briganti A, Roupret M, Shariat SF, Lee C, Minervini A, Moschini M, Mari A; European Association of Urology-Young Academic Urologists Urothelial Carcinoma Working Group. Enhancing Recovery After Major Bladder Cancer Surgery: Comprehensive Review and Assessment of Application of the Enhanced Recovery After Surgery Guidelines. Eur Urol Focus. 2022 Nov;8(6):1622-1626. doi: 10.1016/j.euf.2022.06.004. Epub 2022 Jun 27.
PubMed 35773181Hussein AA, Elsayed AS, Aldhaam NA, Jing Z, Peabody JO, Wijburg CJ, Wagner A, Canda AE, Khan MS, Scherr D, Schanne F, Maatman TJ, Kim E, Mottrie A, Aboumohamed A, Gaboardi F, Pini G, Kaouk J, Yuh B, Rha KH, Hemal A, Palou Redorta J, Badani K, Saar M, Stockle M, Richstone L, Roupret M, Balbay D, Dasgupta P, Menon M, Guru KA. A comparative propensity score-matched analysis of perioperative outcomes of intracorporeal vs extracorporeal urinary diversion after robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. BJU Int. 2020 Aug;126(2):265-272. doi: 10.1111/bju.15083. Epub 2020 May 16.
PubMed 32306494
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stentless Florence Robotic Intracorporeal Neobladder (FloRIN)
- ClinicalTrials.gov ID
- NCT05891535
- Acronym / sponsor ID
- StentlessFloRIN
- Conditions
- Perioperative Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stentless FloRIN | Experimental | Procedure: Robot assisted radical cystectomy without mono J ureteral stent placementFlorence robotic Intra Corporeal Neobladder configuration was performed without the employement of Mono J ureteral catheters |
| Stented FloRIN | Active comparator | Procedure: Robot assisted radical cystectomy with mono J ureteral stent placementFlorence robotic Intra Corporeal Neobladder configuration was performed with the employement of Mono J ureteral catheters |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot assisted radical cystectomy without mono J ureteral stent placementRobot assisted radical cystectomy with/without ureteral mono J stent placement during uretero-neobladder anastomosis | Procedure or surgery | Stentless FloRIN |
| Robot assisted radical cystectomy with mono J ureteral stent placementRobot assisted radical cystectomy with/without ureteral mono J stent placement during uretero-neobladder anastomosis | Procedure or surgery | Stented FloRIN |
Primary outcome
Mid term complications
Time frame: 6 months
Mid term complications rate
1 secondary outcome
Preoperative complications
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Background: PubMed 24183419Ahmed K, Khan SA, Hayn MH, Agarwal PK, Badani KK, Balbay MD, Castle EP, Dasgupta P, Ghavamian R, Guru KA, Hemal AK, Hollenbeck BK, Kibel AS, Menon M, Mottrie A, Nepple K, Pattaras JG, Peabody JO, Poulakis V, Pruthi RS, Redorta JP, Rha KH, Richstone L, Saar M, Scherr DS, Siemer S, Stoeckle M, Wallen EM, Weizer AZ, Wiklund P, Wilson T, Woods M, Khan MS. Analysis of intracorporeal compared with extracorporeal urinary diversion after robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. Eur Urol. 2014 Feb;65(2):340-7. doi: 10.1016/j.eururo.2013.09.042. Epub 2013 Oct 9.
- Background: PubMed 32061537Dell'Oglio P, Mazzone E, Lambert E, Vollemaere J, Goossens M, Larcher A, Van Der Jeugt J, Devos G, Poelaert F, Uvin P, Collins J, De Naeyer G, Schatteman P, D'Hondt F, Mottrie A. The Effect of Surgical Experience on Perioperative and Oncological Outcomes After Robot-assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Evidence from a Referral Centre with Extensive Experience in Robotic Surgery. Eur Urol Focus. 2021 Mar;7(2):352-358. doi: 10.1016/j.euf.2020.01.016. Epub 2020 Feb 13.
- Background: PubMed 19782876McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration; Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8.
- Background: PubMed 29140596Minervini A, Vanacore D, Vittori G, Milanesi M, Tuccio A, Siena G, Campi R, Mari A, Gavazzi A, Carini M. Florence robotic intracorporeal neobladder (FloRIN): a new reconfiguration strategy developed following the IDEAL guidelines. BJU Int. 2018 Feb;121(2):313-317. doi: 10.1111/bju.14077. Epub 2017 Dec 11.
- Background: PubMed 35484043Di Maida F, Grosso AA, Tasso G, Gemma L, Lambertini L, Nardoni S, Mari A, Tuccio A, Vittori G, Masieri L, Minervini A. Robot assisted radical cystectomy with Florence Robotic Intracorporeal Neobladder (FloRIN): Functional and urodynamic features compared with a contemporary series of open Vescica Ileale Padovana (VIP). Eur J Surg Oncol. 2022 Aug;48(8):1854-1861. doi: 10.1016/j.ejso.2022.04.007. Epub 2022 Apr 20.
- Background: PubMed 34023169Minervini A, Di Maida F, Tasso G, Mari A, Bossa R, Sforza S, Grosso AA, Tellini R, Vittori G, Siena G, Tuccio A, Masieri L, Carini M. Robot assisted radical cystectomy with Florence robotic intracorporeal neobladder (FloRIN): Analysis of survival and functional outcomes after first 100 consecutive patients upon accomplishment of phase 3 IDEAL framework. Eur J Surg Oncol. 2021 Oct;47(10):2651-2657. doi: 10.1016/j.ejso.2021.05.007. Epub 2021 May 15.
- Background: PubMed 32303901Beano H, He J, Hensel C, Worrilow W, Townsend W, Gaston K, Clark PE, Riggs S. Safety of decreasing ureteral stent duration following radical cystectomy. World J Urol. 2021 Feb;39(2):473-479. doi: 10.1007/s00345-020-03191-2. Epub 2020 Apr 17.
- Background: PubMed 30732463Scotland KB, Lo J, Grgic T, Lange D. Ureteral stent-associated infection and sepsis: pathogenesis and prevention: a review. Biofouling. 2019 Jan;35(1):117-127. doi: 10.1080/08927014.2018.1562549. Epub 2019 Feb 8.
- Background: PubMed 34416355Peng YL, Ning K, Wu ZS, Li ZY, Deng MH, Xiong LB, Yu CP, Zhang ZL, Liu ZW, Lu HM, Zhou FJ. Ureteral stents cannot decrease the incidence of ureteroileal anastomotic stricture and leakage: A systematic review and meta-analysis. Int J Surg. 2021 Sep;93:106058. doi: 10.1016/j.ijsu.2021.106058. Epub 2021 Aug 18.
- Background: PubMed 3558716Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
- Background: PubMed 1233242Joyce CR, Zutshi DW, Hrubes V, Mason RM. Comparison of fixed interval and visual analogue scales for rating chronic pain. Eur J Clin Pharmacol. 1975 Aug 14;8(6):415-20. doi: 10.1007/BF00562315.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Lambertini, Dr contact
Andrea Minervini, Prof. study director
University of Florence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot assisted radical cystectomy without mono J ureteral stent placement and Robot assisted radical cystectomy with mono J ureteral stent placement in people with Perioperative Complication, run by University of Florence at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Minervini, Prof. (3386483466, andreamine@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mid term complications (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05891535, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.