MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy (MOSAIC)

April 26, 2023 updated by: Jørgen Bjerggaard Jensen

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Aalborg, Denmark, 9100
        • Department of Urology, Aalborg University Hospital
      • Aarhus, Denmark, 8200
        • Department of Urology, Aarhus University Hospital
      • Herlev, Denmark, 2730
        • Department of Urology, Herlev and Gentofte Hospital
      • København, Denmark, 2100
        • Department of Urology, Rigshospitalet
      • Odense, Denmark, 5000
        • Department of Urology, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Study subject will cohere to current national guidlines with a 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.
Other Names:
  • Conventional ileal conduit
Experimental: Intervention
Subject in the interventional arm, will be treated with a cystectomy and modified retrosigmoid 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.
Other Names:
  • Retrosigmoid conduit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strictures
Time Frame: Within 2 years after cystectomy
Number of participants with benign strictures in the left ureter
Within 2 years after cystectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2020

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 13, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Mosaic (ArQule)
  • DaBlaCa-16 (Other Identifier: Danish Bladder Cancer Group)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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