Randomized Controlled Trial With a MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy - MOSAIC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- Jørgen Bjerggaard Jensen
- Enrollment
- 300
- Locations
- 5
- Primary Endpoint
- Strictures
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Jørgen Bjerggaard Jensen
Professor, Consultant, MD, DMSc
Aarhus University Hospital
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
Outcomes
Primary Outcomes
Strictures
Time Frame: Within 2 years after cystectomy
Number of participants with benign strictures in the left ureter