NCT04391790

MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy

Randomized Controlled Trial With a MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy - MOSAIC

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Jørgen Bjerggaard Jensen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cystectomy is the chosen treatment of bladder cancer in 400 cases every year in DK. In replacement of the removed bladder, a urinary diversion is constructed using 15cm of terminal ilium (Ad Modum Bricker). Ureteral strictures are diagnosed in 15% of the cystectomized patients, and these patients are at increased risk of infections, loss of renal function and repeated interventions. The left ureter is diagnosed with 70% of all strictures, presumably due to the construction of the urinary diversion. A modified urinary diversion have been tested in two small studies. The modified diversion is prolonged with 5cm compared to the conventional urinary diversion. The prolongation permits the urinary diversion to reach both the left and the right side of the abdomen, resulting in greater resection of non-viably distal ureter and less mobilization of the left ureter, lowering the rates of strictures.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
PROCEDURE	Cystectomy and modified urinary conduit	The modified retrosigmoid conduit is extended aorund 5 cm, so the left ureter does not have to cross under the mesentery wheras the presumed more robust ileal segment does.
PROCEDURE	Cystectomy and standard urinary conduit ad modum Bricker	The conduit is constructed using approximately 15 cm of terminal ileum and placed in the right side of the abdomen. In order for the left ureter to reach the conduit, it is mobilized behind the sigmoideum to the conduit.

Timeline

• Start date: 2020-05-27
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2020-05-18
• Last updated: 2023-04-27

Locations

5 sites across 1 country: Denmark