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Trial record 1 of 4 for:    mosaic | Bladder Cancer
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MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy (MOSAIC)

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ClinicalTrials.gov Identifier: NCT04391790
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
Jørgen Bjerggaard Jensen, Aarhus University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Bladder Cancer Procedure: Cystectomy and modified urinary conduit Procedure: Cystectomy and standard urinary conduit ad modum Bricker Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, multicenter, randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial With a MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy - MOSAIC
Actual Study Start Date : May 27, 2020
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Study subject will cohere to current national guidlines with a cystectomy and standard urinary conduit ad modum Bricker
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.
Other Name: Conventional ileal conduit

Experimental: Intervention
Subject in the interventional arm, will be treated with a cystectomy and modified retrosigmoid conduit
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.
Other Name: Retrosigmoid conduit




Primary Outcome Measures :
  1. Strictures [ Time Frame: Within 2 years after cystectomy ]
    Number of participants with benign strictures in the left ureter



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391790


Contacts
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Contact: Jørgen Bjerggaard Jensen, Professor, DMSc +45 78452617 Bjerggaard@skejby.rm.dk
Contact: Simone Brandt, MD simbra@rm.dk

Locations
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Denmark
Department of Urology, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9100
Contact: Knud Fabrin, MD         
Sub-Investigator: Astrid Helene Livbjerg, MD         
Department of Urology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Simone Brandt, MD         
Department of Urology, Herlev and Gentofte Hospital Recruiting
Herlev, Denmark, 2730
Contact: Gitte Wrist Lam, MD         
Sub-Investigator: Michael Vangedal, MD         
Department of Urology, Rigshospitalet Recruiting
København, Denmark, 2100
Contact: Ulla Nordström Joensen, MD, PhD Assoc. Professor         
Department of Urology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Thor Knak Jensen, MD         
Sponsors and Collaborators
Jørgen Bjerggaard Jensen
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Responsible Party: Jørgen Bjerggaard Jensen, Professor, Consultant, MD, DMSc, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04391790    
Other Study ID Numbers: MOSAIC
DaBlaCa-16 ( Other Identifier: Danish Bladder Cancer Group )
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jørgen Bjerggaard Jensen, Aarhus University Hospital:
ureteral strictures
urinary diversion
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical