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

Primary Purpose

Bladder Cancer

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cystectomy and modified urinary conduit
Cystectomy and standard urinary conduit ad modum Bricker
Sponsored by
Jørgen Bjerggaard Jensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bladder Cancer focused on measuring ureteral strictures, urinary diversion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Urology, Aalborg University Hospital
  • Department of Urology, Aarhus University Hospital
  • Department of Urology, Herlev and Gentofte Hospital
  • Department of Urology, Rigshospitalet
  • Department of Urology, Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

Study subject will cohere to current national guidlines with a cystectomy and standard urinary conduit ad modum Bricker

Subject in the interventional arm, will be treated with a cystectomy and modified retrosigmoid conduit

Outcomes

Primary Outcome Measures

Strictures
Number of participants with benign strictures in the left ureter

Secondary Outcome Measures

Full Information

First Posted
May 13, 2020
Last Updated
April 26, 2023
Sponsor
Jørgen Bjerggaard Jensen
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1. Study Identification

Unique Protocol Identification Number
NCT04391790
Brief Title
MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy
Acronym
MOSAIC
Official Title
Randomized Controlled Trial With a MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy - MOSAIC
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jørgen Bjerggaard Jensen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
ureteral strictures, urinary diversion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, multicenter, randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Study subject will cohere to current national guidlines with a cystectomy and standard urinary conduit ad modum Bricker
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Subject in the interventional arm, will be treated with a cystectomy and modified retrosigmoid conduit
Intervention Type
Procedure
Intervention Name(s)
Cystectomy and modified urinary conduit
Other Intervention Name(s)
Retrosigmoid conduit
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cystectomy and standard urinary conduit ad modum Bricker
Other Intervention Name(s)
Conventional ileal conduit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Strictures
Description
Number of participants with benign strictures in the left ureter
Time Frame
Within 2 years after cystectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Urology, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Department of Urology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Department of Urology, Herlev and Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Department of Urology, Rigshospitalet
City
København
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Department of Urology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

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MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy

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