MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy

Overview

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.

Full Title of Study: “Randomized Controlled Trial With a MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy – MOSAIC”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2023

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Control
    • Study subject will cohere to current national guidlines with a cystectomy and standard urinary conduit ad modum Bricker
  • Experimental: Intervention
    • Subject in the interventional arm, will be treated with a cystectomy and modified retrosigmoid conduit

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jørgen Bjerggaard Jensen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jørgen Bjerggaard Jensen, Professor, Consultant, MD, DMSc – Aarhus University Hospital
  • Overall Contact(s)
    • Jørgen Bjerggaard Jensen, Professor, DMSc, +45 78452617, Bjerggaard@skejby.rm.dk

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