CystectomyNCT02665156
Time Efficiency of Intracorporeal Orthotopic Diversion With Robotic Staplers After Robot Assisted Radical Cystectomy
A study testing Intracorporeal stapled neobladder using robotic staplers in people with Cystectomy and Robotic Surgical Procedures, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
Objectives and Specific Aims Time efficiency of robot assisted radical cystectomy (RARC) with totally intracorporeal stapled orthotopic neobladder remains a main drawback of this procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystectomy, Robotic Surgical Procedures, Surgical Staplers
- What is being tested?
- Intracorporeal stapled neobladder using robotic staplers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Sep 2018
- 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
- Pathologically confirmed muscle invasive bladder cancer or recurrent high grade urothelial carcinoma (BCG failures)
Who cannot join
- All absoulte contraindications to orthotopic neobladder;
- Anesthesiologic contraindications to penumoeperitoneum and steep Trendelenburg position.
- cT4 disease;
- clinical evidence of metastases (cM1) outside the pelvis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Clinical Trial to Assess Time Efficiency of Intracorporeal Orthotopic Diversion With Robotic Staplers After Robot Assisted Radical Cystectomy
Objectives and Specific Aims Time efficiency of robot assisted radical cystectomy (RARC) with totally intracorporeal stapled orthotopic neobladder remains a main drawback of this procedure. According to a recent consensus panel, the benchmark for intracorporeal orthotopic neobladder should be 5 hours in high volume centers .
This prospective single-stage phase 2 trial is designed to assess the time efficiency of using robotic stapler versus the conventional motorized staplers (Linear stapler articulated Endo GIA™, Covidien) in achieving the target outcome (total operative time <5 hr).
Perioperative complications (intraoperative and 30-d postoperative complications according to the Clavien classification system), 30-d/90-d/ 180-d complication and readmission rates, early functional outcomes (time to recovery of urinary continence), 180-d and 360-d neobladder stone formation rates will be analyzed to assess the safety and the cost effectiveness of the procedure.
Read the detailed description
The primary end point by which the sample size was determined was a total operative time <5hr. In the last 50 cases of our series (data unpublished) this benchmark was obtained in 60% of patients (p0), while we expect to improve the time efficiency of the procedure with the use of robotic staplers maintaining the total operative time of the procedure <5hrs in at least 80% (p1) of cases. According to A'Hern, in order to verify the significance of this hypothesis, the estimated sample size is 33 patients with a power of 80% at a significance level of 5%. The trial will be successful if the total operative time will be <5hrs in at least 25 out of 33 patients.
The population of this study will include 35 patients with muscle invasive bladder cancer without contraindications to orthotopic neobladder. The first two cases will be excluded in order to provide the entire surgical team the minimal skill necessary for a proper and time efficient use of the new surgical device (robotic stapler). The following 33 consecutive cases will be enrolled and the outcomes analyzed. The estimated time to complete the enrollment is 9 months.
- Conditions
- Cystectomy, Robotic Surgical Procedures, Surgical Staplers
- Being tested
- Intracorporeal stapled neobladder using robotic staplers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracorporeal stapled neobladder using robotic staplersProcedure or surgery
Robot assisted radical cystecomy. Separate packages extended pelvic lymph node dissection up to aortic bifurcation. Totally intracorporeal orthotopic ileal neobladder with about 45 cm of ileum according to "Vescica Ileal Padovana".
| Study group | Role | What they receive |
|---|---|---|
| Robotic Stapled orthotopic neobladder | Experimental | Intracorporeal stapled neobladder using robotic staplers: Partly stapled orthotopic neobladder: robotic staplers applied to create the neobladder neck and to suture the left side of the posterior aspect of neobladder. Right side of the posterior aspect of neobladder and the anterior aspect of the neobladder hand sewn. Receives: Procedure: Intracorporeal stapled neobladder using robotic staplers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving time efficiency, achieving a total operative <5 hrs in 80% of cases (28/33)
Measured: 1 yr
Secondary outcomes (4)
Perioperative complications
Assessment of perioperative complications 30 days, 90 days and 180 days after surgery
Measured: 6 months
Readmission rate
Incidence of readmission
Measured: 6 months
Neobladder stone formation
Incidence of neobladder stone formation
Measured: 1-yr
Cost analysis
Measured: 1-yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystectomyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Surgical
- Responsible party
- Principal investigator, Giuseppe SImone, Regina Elena Cancer Institute
- Investigators
- Giuseppe Simone, Ph.D., Principal investigator, "Regina Elena" National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665156
- Sponsor's protocol ID
- 1034/15
- Status last verified
- Mar 2019
- First submitted
- 19 Jan 2016
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Trial to Assess Time Efficiency of Intracorporeal Orthotopic Diversion With Robotic Staplers After Robot Assisted Radical Cystectomy
- ClinicalTrials.gov ID
- NCT02665156
- Acronym / sponsor ID
- 1034/15
- Conditions
- Cystectomy, Robotic Surgical Procedures, Surgical Staplers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Intuitive Surgical
- Study start
- Jan 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 27 Jan 2016 (estimated)
- 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.
Objectives and Specific Aims Time efficiency of robot assisted radical cystectomy (RARC) with totally intracorporeal stapled orthotopic neobladder remains a main drawback of this procedure. According to a recent consensus panel, the benchmark for intracorporeal orthotopic neobladder should be 5 hours in high volume centers .
This prospective single-stage phase 2 trial is designed to assess the time efficiency of using robotic stapler versus the conventional motorized staplers (Linear stapler articulated Endo GIA™, Covidien) in achieving the target outcome (total operative time <5 hr).
Perioperative complications (intraoperative and 30-d postoperative complications according to the Clavien classification system), 30-d/90-d/ 180-d complication and readmission rates, early functional outcomes (time to recovery of urinary continence), 180-d and 360-d neobladder stone formation rates will be analyzed to assess the safety and the cost effectiveness of the procedure.
Detailed description
The primary end point by which the sample size was determined was a total operative time <5hr. In the last 50 cases of our series (data unpublished) this benchmark was obtained in 60% of patients (p0), while we expect to improve the time efficiency of the procedure with the use of robotic staplers maintaining the total operative time of the procedure <5hrs in at least 80% (p1) of cases. According to A'Hern, in order to verify the significance of this hypothesis, the estimated sample size is 33 patients with a power of 80% at a significance level of 5%. The trial will be successful if the total operative time will be <5hrs in at least 25 out of 33 patients.
The population of this study will include 35 patients with muscle invasive bladder cancer without contraindications to orthotopic neobladder. The first two cases will be excluded in order to provide the entire surgical team the minimal skill necessary for a proper and time efficient use of the new surgical device (robotic stapler). The following 33 consecutive cases will be enrolled and the outcomes analyzed. The estimated time to complete the enrollment is 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Stapled orthotopic neobladder | Experimental | Procedure: Intracorporeal stapled neobladder using robotic staplersIntracorporeal stapled neobladder using robotic staplers: Partly stapled orthotopic neobladder: robotic staplers applied to create the neobladder neck and to suture the left side of the posterior aspect of neobladder. Right side of the posterior aspect of neobladder and the anterior aspect of the neobladder hand sewn. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pathologically confirmed muscle invasive bladder cancer or recurrent high grade urothelial carcinoma (BCG failures)
Key exclusion criteria (4 listed)
- All absoulte contraindications to orthotopic neobladder;
- Anesthesiologic contraindications to penumoeperitoneum and steep Trendelenburg position.
- cT4 disease;
- clinical evidence of metastases (cM1) outside the pelvis.
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 |
|---|---|---|
| Intracorporeal stapled neobladder using robotic staplersRobot assisted radical cystecomy. Separate packages extended pelvic lymph node dissection up to aortic bifurcation. Totally intracorporeal orthotopic ileal neobladder with about 45 cm of ileum according to "Vescica Ileal Padovana". | Procedure or surgery | Robotic Stapled orthotopic neobladder |
Primary outcome
Improving time efficiency, achieving a total operative <5 hrs in 80% of cases (28/33)
Time frame: 1 yr
4 secondary outcomes
Perioperative complications
Time frame: 6 months
Readmission rate
Time frame: 6 months
Neobladder stone formation
Time frame: 1-yr
Cost analysis
Time frame: 1-yr
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 28 Mar 2019.
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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, Ph.D. principal investigator
"Regina Elena" National Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracorporeal stapled neobladder using robotic staplers in people with Cystectomy and Robotic Surgical Procedures, 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 4 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 28 Mar 2019. 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?
Improving time efficiency, achieving a total operative <5 hrs in 80% of cases (28/33) (time frame: 1 yr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2019.