Time Efficiency of Intracorporeal Orthotopic Diversion With Robotic Staplers After Robot Assisted Radical Cystectomy

NCT ID: NCT02665156

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-09-30

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 In the last 50 cases of our series (data unpublished) this benchmark was obtained in 60% of patients (p0), while we expect to improve the time efficiency of the procedure with the use of robotic staplers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

Conditions

Cystectomy; Robotic Surgical Procedures; Surgical Staplers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic Stapled orthotopic neobladder

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.

Group Type: EXPERIMENTAL

Intracorporeal stapled neobladder using robotic staplers

Intervention Type: PROCEDURE

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".

Interventions

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".

Intervention Type: PROCEDURE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intuitive Surgical

INDUSTRY

Sponsor Role: collaborator

Regina Elena Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe SImone

Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe Simone, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

"Regina Elena" National Cancer Institute

Locations

"Regina Elena" National Cancer Institute

Rome, , Italy

Countries

Italy

Other Identifiers

1034/15

Identifier Type: -

Identifier Source: org_study_id