NCT03385798: EGIAES

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

Completed NA Last updated 31 May 2023

What this trial tests

NA trial testing Endowrist in Bladder Cancer in 90 participants. Completed in 1 January 2023.

Timeline

1 January 2018

Primary endpoint
1 January 2020

1 January 2023

Quick facts

Lead sponsor	Jørgen Bjerggaard Jensen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	1 January 2018
Primary completion	1 January 2020
Estimated completion	1 January 2023
Sites	1 location across Denmark

Drugs / interventions tested

• Endowrist
• Endo-GIA

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

Jørgen Bjerggaard Jensen — full company profile →

Who can join

18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of the EndoGIA versus the Endowrist stapler in intracorporeal urinary diversion in robotic assisted radical cystectomy (EGIAES) - a randomized multicentre trial.
   Bak R, Fabrin K, Jensen TK, Olsen KØ, et al · · 2025 · PMID 41335393 · DOI 10.1007/s11701-025-03009-6