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Endo-GIA Versus Endowrist Stapler in Intracorporeal Urinary Diversion in Robotic Assisted Radical Cystectomy

NCT03385798 · Jørgen Bjerggaard Jensen · Updated 31 May 2023

What is being tested
Endowrist; Endo-GIA
For
Bladder Cancer
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 90 people. The full rules are on the registry page.
Where
Denmark
When
Starts or started 1 Jan 2018, ends 1 Jan 2023. Registered 29 Dec 2017.
Results
None posted yet.

In the researchers' words

The study is a randomized clinical trial (RCT) including patients undergoing robotic assisted cystectomy with intracorporeal ileal conduit at four large university hospitals in Denmark. If included, the patients will be randomized 1:1 to two study arms: 1) Standard arm with current procedure where intracorporeal bowel anastomosis is performed with the 60 mm EndoGIA stapler, or 2) Experimental arm where the bowel anastomosis will be performed totally robotic with the Endowrist Intuitive robotic stapler with 2 subsequent elongated 45 mm magazines for the side-to-side anastomosis. Primary outcome will be postoperative bowel function where a better bowel recovery is anticipated in the experimental Endowrist arm whereas serious complications are expected to be non-inferior to the current standard.
ClinicalTrials.gov, NCT03385798

Sites

  • Aarhus University HospitalAarhus, Denmark