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

NCT02665156 · Regina Elena Cancer Institute · Updated 28 March 2019

What is being tested
Intracorporeal stapled neobladder using robotic staplers
For
Cystectomy; Robotic Surgical Procedures; Surgical Staplers
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages Not stated. About 33 people. The full rules are on the registry page.
Where
Italy
When
Starts or started Jan 2016, ends Sept 2018. Registered 27 Jan 2016.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT02665156

Sites

  • "Regina Elena" National Cancer InstituteRome, Italy