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

NCT02665156 | Completed

• 1 other identifier: 1034/15
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystectomy; Robotic Surgical Procedures; Surgical Staplers

Outcome Measures

Primary Outcomes (1)

• Improving time efficiency, achieving a total operative <5 hrs in 80% of cases (28/33)

  1 yr

Secondary Outcomes (4)

• Perioperative complications

  6 months

• Readmission rate

  6 months

• Neobladder stone formation

  1-yr

• Cost analysis

  1-yr

Study Arms (1)

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.

Procedure: Intracorporeal stapled neobladder using robotic staplers

Interventions

Intracorporeal stapled neobladder using robotic staplers 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".

Robotic Stapled orthotopic neobladder

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Intuitive Surgical: collaborator

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

Location

Study Officials

• Giuseppe Simone, Ph.D.

  "Regina Elena" National Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 27, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: September 1, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

IT (1)