Clinical trial NCT02665156: Time Efficiency of Intracorporeal Orthotopic Diversion With Robotic Staplers After Robot Assisted Radical Cystectomy
Official title: Phase 2 Clinical Trial to Assess Time Efficiency of Intracorporeal Orthotopic Diversion With Robotic Staplers After Robot Assisted Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystectomy
Robotic Surgical Procedures
Surgical Staplers
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Intuitive Surgical
First posted: 2016-01-27
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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 In the last 50 cases of our series (data unpublished) this benchmark was obtained in 60% of patients (p0), while we expect to improve the time efficiency of the procedure with the use of robotic staplers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.

Eligibility criteria: Inclusion Criteria:

- Pathologically confirmed muscle invasive bladder cancer or recurrent high grade urothelial carcinoma (BCG failures)

Exclusion Criteria:

* All absoulte contraindications to orthotopic neobladder;
* Anesthesiologic contraindications to penumoeperitoneum and steep Trendelenburg position.
* cT4 disease;
* clinical evidence of metastases (cM1) outside the pelvis.

Primary outcomes:
measure: Improving time efficiency, achieving a total operative <5 hrs in 80% of cases (28/33)
timeFrame: 1 yr
Secondary outcomes:
measure: Perioperative complications
timeFrame: 6 months
measure: Readmission rate
timeFrame: 6 months
measure: Neobladder stone formation
timeFrame: 1-yr
measure: Cost analysis
timeFrame: 1-yr
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
affiliation: "Regina Elena" National Cancer Institute
name: Giuseppe Simone, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: