MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: Cystectomy and modified urinary conduit
* Procedure: Cystectomy and standard urinary conduit ad modum Bricker


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, multicenter, randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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<br>* 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.<br>* Other names: Conventional ileal conduit;|
| Experimental: Intervention<br>Subject in the interventional arm, will be treated with a cystectomy and modified retrosigmoid conduit | Procedure: Cystectomy and modified urinary conduit<br>* 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.<br>* Other names: Retrosigmoid conduit;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ureteral strictures, urinary diversion