MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy

Bladder Cancer Clinical Trial

— MOSAIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04391790
• Other study ID #: MOSAIC
• Secondary ID: DaBlaCa-16
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 27, 2020
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2023
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Bladder cancer with the indication for robot assisted radical cystectomy

• Ileal conduit ad modum Bricker as planned urinary diversion

• Ability to understand the participant information orally and in writing

• Signed consent form

Exclusion Criteria:

• Previous abdominal or pelvic radiotherapy

• Previous major abdominal surgery involving resection of bowel or construction of an enteric stoma

• Urostomy planned on the left side of the abdomen

• Single kidney

• Complete ureteral duplication (either uni- or bilaterally), known at time of inclusion

• Pregnancy

Related Conditions & MeSH terms

• Bladder Cancer
• Constriction, Pathologic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Urology, Aalborg University Hospital	Aalborg
Denmark	Department of Urology, Aarhus University Hospital	Aarhus
Denmark	Department of Urology, Herlev and Gentofte Hospital	Herlev
Denmark	Department of Urology, Rigshospitalet	København
Denmark	Department of Urology, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Jørgen Bjerggaard Jensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strictures	Number of participants with benign strictures in the left ureter	Within 2 years after cystectomy