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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.
Sites
- "Regina Elena" National Cancer InstituteRome, Italy
