An interventional study of Intracorporeal stapled neobladder using robotic staplers in Cystectomy, Robotic Surgical Procedures and Surgical Staplers, sponsored by Regina Elena Cancer Institute. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2019-03-28.
Sponsored by Regina Elena Cancer Institute · Not applicable, Interventional, and Treatment
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 In the last 50 cases of our series (data unpublished) this benchmark was obtained in 60% of patients (p0), while we expect to improve the time efficiency of the procedure with the use of robotic staplers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.
Regina Elena Cancer Institute is the lead sponsor of 92 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Intracorporeal stapled neobladder using robotic staplers
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".
Improving time efficiency, achieving a total operative <5 hrs in 80% of cases (28/33)
Time frame: 1 yr
Perioperative complications
Assessment of perioperative complications 30 days, 90 days and 180 days after surgery
Time frame: 6 months
Readmission rate
Incidence of readmission
Time frame: 6 months
Neobladder stone formation
Incidence of neobladder stone formation
Time frame: 1-yr
Cost analysis
Time frame: 1-yr
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Regina Elena Cancer Institute