Robotic Surgical Procedures Clinical Trial
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.
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 In the last 50 cases of our series (data unpublished) this benchmark was obtained in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.
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