Bladder CancerNCT03434132
Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion.
A study testing Open or robotic radical cystectomy in people with Bladder Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Open or robotic radical cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jan 2018to 30 Sep 2022
- 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 muscle invasive high grade urothelial carcinoma (and variant histologies) of the bladder or high grade non muscle invasive BCG recurrent/refractory disease.
Who cannot join
- Cystectomy without curative intent (palliative, salvage).
- Patients unfit for robotic cystectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion. Single Centre Prospective Randomized Trial.
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).
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Open or robotic radical cystectomy
- Keywords
- Open Radical Cystectomy, Robotic Radical cystectomy, Intracorporeal urinary diversion, Prospective randdomized trial
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open or robotic radical cystectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Open Radical Cystectomy | Active comparator | Open Radical Cystectomy, pelvic lymph node dissection, urinary diversion (neobladder or ileal conduit) Receives: Procedure: Open or robotic radical cystectomy |
| Robot assisted radical cystectomy | Experimental | Robot assisted radical cystectomy, pelvic lymph node dissection, intracorporeal urinary diversion (neobladder or ileal conduit) Receives: Procedure: Open or robotic radical cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants requiring perioperative transfusions.
50% reduction of perioperative transfusion rates in robotic arm.
Measured: 30 days
Secondary outcomes (6)
Number of participants requiring insertion of nasogastric tube
Comparison between open and robotic arms.
Measured: 30 days
Incidence of Clavien grade 1-2 perioperative complications at 30-d evaluation.
Comparison between open and robotic arms.
Measured: 30 days
Incidence of Clavien grade 1-2 perioperative complications at 90-d evaluation.
Comparison between open and robotic arms.
Measured: 90 days
Incidence of Clavien grade 1-2 perioperative complications at 180-d evaluation.
Comparison between open and robotic arms.
Measured: 180 days
Incidence of patients requiring readmission.
Comparison between open and robotic arms.
Measured: 90 days
Cost analysis.
Comparison between open and robotic arms.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start29 Jan 2018
- Primary completion30 Oct 2020
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ministero della Salute, Italy
- Responsible party
- Principal investigator, Giuseppe SImone, Regina Elena Cancer Institute
- Investigators
- Giuseppe Simone, PhD, Principal investigator, "Regina Elena" National Cancer Institute, Dept of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434132
- Sponsor's protocol ID
- GR2016-02364306
- Status last verified
- Jan 2023
- First submitted
- 26 Jan 2018
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mastroianni R, Tuderti G, Anceschi U, Bove AM, Brassetti A, Ferriero M, Zampa A, Giannarelli D, Guaglianone S, Gallucci M, Simone G. Comparison of Patient-reported Health-related Quality of Life Between Open Radical Cystectomy and Robot-assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Interim Analysis of a Randomised Controlled Trial. Eur Urol Focus. 2022 Mar;8(2):465-471. doi: 10.1016/j.euf.2021.03.002. Epub 2021 Mar 10.
PubMed 33712389
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion. Single Centre Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT03434132
- Acronym / sponsor ID
- GR2016-02364306
- Conditions
- Bladder Cancer
- Keywords
- Open Radical Cystectomy, Robotic Radical cystectomy, Intracorporeal urinary diversion, Prospective randdomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Ministero della Salute, Italy
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 15 Feb 2018 (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.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Radical Cystectomy | Active comparator | Procedure: Open or robotic radical cystectomyOpen Radical Cystectomy, pelvic lymph node dissection, urinary diversion (neobladder or ileal conduit) |
| Robot assisted radical cystectomy | Experimental | Procedure: Open or robotic radical cystectomyRobot assisted radical cystectomy, pelvic lymph node dissection, intracorporeal urinary diversion (neobladder or ileal conduit) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with muscle invasive high grade urothelial carcinoma (and variant histologies) of the bladder or high grade non muscle invasive BCG recurrent/refractory disease.
Key exclusion criteria (2 listed)
- Cystectomy without curative intent (palliative, salvage).
- Patients unfit for robotic cystectomy.
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 |
|---|---|---|
| Open or robotic radical cystectomyORC 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. | Procedure or surgery | Open Radical Cystectomy, Robot assisted radical cystectomy |
Primary outcome
Number of participants requiring perioperative transfusions.
Time frame: 30 days
50% reduction of perioperative transfusion rates in robotic arm.
6 secondary outcomes
Number of participants requiring insertion of nasogastric tube
Time frame: 30 days
Incidence of Clavien grade 1-2 perioperative complications at 30-d evaluation.
Time frame: 30 days
Incidence of Clavien grade 1-2 perioperative complications at 90-d evaluation.
Time frame: 90 days
Incidence of Clavien grade 1-2 perioperative complications at 180-d evaluation.
Time frame: 180 days
Incidence of patients requiring readmission.
Time frame: 90 days
Cost analysis.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Derived from this study: PubMed 33712389Mastroianni R, Tuderti G, Anceschi U, Bove AM, Brassetti A, Ferriero M, Zampa A, Giannarelli D, Guaglianone S, Gallucci M, Simone G. Comparison of Patient-reported Health-related Quality of Life Between Open Radical Cystectomy and Robot-assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Interim Analysis of a Randomised Controlled Trial. Eur Urol Focus. 2022 Mar;8(2):465-471. doi: 10.1016/j.euf.2021.03.002. Epub 2021 Mar 10.
- 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.
Giuseppe Simone, PhD principal investigator
"Regina Elena" National Cancer Institute, Dept of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open or robotic radical cystectomy in people with Bladder Cancer, run by Regina Elena Cancer Institute 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 19 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants requiring perioperative transfusions. (time frame: 30 days). 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 NCT03434132, which also lists 1 linked publication.
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 19 Jan 2023.