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Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion.

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ClinicalTrials.gov Identifier: NCT03434132
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
Ministero della Salute, Italy
Information provided by (Responsible Party):
Giuseppe SImone, Regina Elena Cancer Institute

Brief Summary:
This prospective randomized study is designed to provide high level of evidence supporting superiority of robot assisted (RA) versus open (O) radical cystectomy (RC). The primary endpoint is a 50% reduction of transfusion rate, several perioperative outcomes potentially linked to a reduced invasiveness are considered as secondary endpoints. Investigators hypothesis is that the reduced invasiveness of RARC might turn into a higher adherence to enhanced recovery after surgery (ERAS) protocols (early bowel recovery, reduced need for painkillers and insertion of nasogastric tube) and consequently to shorter hospital stay and to faster return to daily activities. These data will be taken into account in a matched cost analysis between arms. Secondary aims include a between arm matched comparison of perioperative complications, oncologic outcomes (2-yr disease free survival is an accepted surrogate of long term oncologic effectiveness of RC) and functional outcomes (daytime and nighttime continence).

Condition or disease Intervention/treatment Phase
Bladder Cancer Procedure: Open or robotic radical cystectomy Not Applicable

Detailed Description:

Despite encouraging data deriving from colorectal surgery, evidences in favor to ERAS protocols following RARC are poor. Moreover, according to a recent survey of surgeons with a specialist interest in RC, the adherence to ERAS protocols is <20% [1].

Retrospective and preliminary data from the robotic consortium have supported oncologic effectiveness of RARC; however in the only prospective randomized trial comparing RARC and ORC urinary diversions were performed extracorporeally, potentially impairing the benefits of minimally invasive surgery [2].

Robot assisted radical cystectomy (RARC) has the aim of providing adequate cancer control while minimizing invasiveness of open radical cystectomy (ORC). The primary end-point of this trial is to demonstrate a reduction of perioperative transfusion rate in RARC arm by 50% compared to ORC arm.

ERAS protocols may significantly contribute to shortening length of hospital stay, a key outcome in this clinical setting of patients receiving RC, being the mean length of hospital stay around 14 days in Italy. Investigators' hypothesis is that the reduced invasiveness of RARC might contribute to an increased adoption of ERAS protocols (reduced need for reinsertion of nasogastric tube, shorter time to first flatus, to mobilization, to regular diet and finally shorter duration of hospital stay).

Assessment of oncologic outcomes of RARC, although not the primary endpoint of the present study, is certainly an outcome of interest. The expected duration of enrollment (18 mo) should provide 2-yr oncologic outcomes for about 66% of patients. Two-year recurrence free survival has been reported as a valid surrogate marker of long term oncologic survival after RC.

Specific Aim 1:To demonstrate superiority of RARC versus ORC in terms of 50% reduction of perioperative transfusion rates.

Specific Aim 2:

To evaluate invasiveness of both surgical approaches by assessing the adherence to ERAS protocols in both and the incidence of perioperative and 30-d, 90d, 180d complications, readmission rates (30d, 90d). Cost analysis will assess the potential impact of shorter hospital stay on overall costs of robotic procedures.

Specific Aim 3:

To assess quality of life at 6-mo, 12-mo and 24-mo follow-up evaluation and to perform a matched comparison of oncologic and functional outcomes between two arms.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion. Single Centre Prospective Randomized Trial.
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Open Radical Cystectomy
Open Radical Cystectomy, pelvic lymph node dissection, urinary diversion (neobladder or ileal conduit)
Procedure: Open or robotic radical cystectomy

ORC and orthotopic ileal neobladder is performed as previously described. A separate package PLND is performed as in open as in robotic surgery. RARC is performed replicating open surgical procedure.

The orthotopic ileal neobladder model used is the 'vescica ileale padovana' as previously described. An ileal segment, approximately 42 cm long, is chosen at a minimum distance of 20cm far from ileo-cecal valve. A latero-lateral ileal anastomosis is performed with staplers to restore bowel continuity.

For ileal conduit, a 20cm ileal segment (approximately 20 cm long) at a minimum distance of 20 cm from ileo-cecal valve is isolated and transected with staplers. Bowel continuity is restored as previously described. The ileal loop on its distal edge is extracted through abdomen wall at the previously identified stoma point and fixed to abdomen fascia. The ureters are spatulated and a latero-lateral anastomosis according to Wallace 1 technique is performed.


Experimental: Robot assisted radical cystectomy
Robot assisted radical cystectomy, pelvic lymph node dissection, intracorporeal urinary diversion (neobladder or ileal conduit)
Procedure: Open or robotic radical cystectomy

ORC and orthotopic ileal neobladder is performed as previously described. A separate package PLND is performed as in open as in robotic surgery. RARC is performed replicating open surgical procedure.

The orthotopic ileal neobladder model used is the 'vescica ileale padovana' as previously described. An ileal segment, approximately 42 cm long, is chosen at a minimum distance of 20cm far from ileo-cecal valve. A latero-lateral ileal anastomosis is performed with staplers to restore bowel continuity.

For ileal conduit, a 20cm ileal segment (approximately 20 cm long) at a minimum distance of 20 cm from ileo-cecal valve is isolated and transected with staplers. Bowel continuity is restored as previously described. The ileal loop on its distal edge is extracted through abdomen wall at the previously identified stoma point and fixed to abdomen fascia. The ureters are spatulated and a latero-lateral anastomosis according to Wallace 1 technique is performed.





Primary Outcome Measures :
  1. Number of participants requiring perioperative transfusions. [ Time Frame: 30 days ]
    50% reduction of perioperative transfusion rates in robotic arm.


Secondary Outcome Measures :
  1. Number of participants requiring insertion of nasogastric tube [ Time Frame: 30 days ]
    Comparison between open and robotic arms.

  2. Incidence of Clavien grade 1-2 perioperative complications at 30-d evaluation. [ Time Frame: 30 days ]
    Comparison between open and robotic arms.

  3. Incidence of Clavien grade 1-2 perioperative complications at 90-d evaluation. [ Time Frame: 90 days ]
    Comparison between open and robotic arms.

  4. Incidence of Clavien grade 1-2 perioperative complications at 180-d evaluation. [ Time Frame: 180 days ]
    Comparison between open and robotic arms.

  5. Incidence of patients requiring readmission. [ Time Frame: 90 days ]
    Comparison between open and robotic arms.

  6. Cost analysis. [ Time Frame: 30 days ]
    Comparison between open and robotic arms.


Other Outcome Measures:
  1. Assessment of quality of life at 6-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire [ Time Frame: 6 months ]
    Comparison between open and robotic arms.

  2. Assessment of quality of life at 6-mo follow-up with self-administered EORTC QLQ-C30 questionnaire [ Time Frame: 6 months ]
    Comparison between open and robotic arms.

  3. Assessment of quality of life at 12-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire [ Time Frame: 12 months ]
    Comparison between open and robotic arms.

  4. Assessment of quality of life at 12-mo follow-up with self-administered EORTC QLQ-C30 questionnaire [ Time Frame: 12 months ]
    Comparison between open and robotic arms.

  5. Assessment of quality of life at 24-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire [ Time Frame: 24 months ]
    Comparison between open and robotic arms.

  6. Assessment of quality of life at 24-mo follow-up with self-administered EORTC QLQ-C30 questionnaire [ Time Frame: 24 months ]
    Comparison between open and robotic arms.

  7. Disease free survival [ Time Frame: 24 months ]
    Comparison between open and robitic arms

  8. Cancer specific survival [ Time Frame: 24 months ]
    Comparison between open and robitic arms

  9. Overall survival [ Time Frame: 24 months ]
    Comparison between open and robitic arms

  10. Assessment of urinary continence with pad test. [ Time Frame: 12 months ]
    Comparison between open and robotic arms

  11. Assessment of urinary continence with pad test. [ Time Frame: 24 months ]
    Comparison between open and robotic arms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with muscle invasive high grade urothelial carcinoma (and variant histologies) of the bladder or high grade non muscle invasive BCG recurrent/refractory disease.

Exclusion Criteria:

  • Cystectomy without curative intent (palliative, salvage).
  • Patients unfit for robotic cystectomy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434132


Contacts
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Contact: Anna D'ambrosio +390652662719 anna.dambrosio@ifo.gov.it
Contact: Michele Gallucci, MD +390652665005 michele.gallucci@ifo.gov.it

Locations
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Italy
Regina Elena NCI Recruiting
Rome, Lazio, Italy, 00144
Contact: Anna D'Ambrosio    +390652662719    anna.dambrosio@ifo.gov.it   
Sponsors and Collaborators
Regina Elena Cancer Institute
Ministero della Salute, Italy
Investigators
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Principal Investigator: Giuseppe Simone, PhD "Regina Elena" National Cancer Institute, Dept of Urology
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Responsible Party: Giuseppe SImone, MD, PhD, COnsultant Urologist, Regina Elena Cancer Institute
ClinicalTrials.gov Identifier: NCT03434132    
Other Study ID Numbers: GR2016-02364306
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giuseppe SImone, Regina Elena Cancer Institute:
Open Radical Cystectomy
Robotic Radical cystectomy
Intracorporeal urinary diversion
Prospective randdomized trial
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases