Bladder Cancer
Conditions
Keywords
ureteral strictures, urinary diversion
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.
Interventions
PROCEDURECystectomy 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.
PROCEDURECystectomy 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.
Sponsors
Jørgen Bjerggaard Jensen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A prospective, multicenter, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Strictures | Within 2 years after cystectomy | Number of participants with benign strictures in the left ureter |
Countries
Denmark
Outcome results
None listed