Urinary deviation
Conditions
Interventions
Patients who are scheduled for ileal urinary conduit with or without cystectomy
are screened for eligibility and are asked to participate. After 1:1
randomization, 192 patients receive either routin
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18 years and older - Able to understand patient information form (PIF), - Written informed consent, on study participation - Undergoing open or robot-assisted uretero-ileo-cutaneostomy with or without radical cystectomy for urothelial cell carcinoma or other pelvic malignancies, refractory urinary incontinence or refractory detrusor overactivity - eGFR >= 30 ml/min
Exclusion criteria
Exclusion criteria: - Neobladder or any reconstruction other than uretero-ileo-cutaneostomy of the urinary tract - Open uretero-ileo-cutaneostomy - Pre-operative obstruction of the upper urinary tract requiring a nephrostomy catheter or double-J stent - Single-functioning kidney - Previous radiation therapy of the lower pelvis, except for prostate cancer - Salvage Cystectomy - History of colorectal surgery, or M. Crohn/colitis ulcerosa or short bowel syndrome
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - The 90 days postoperatively complication rate which is a composite endpoint of the complications mentioned in the primary endpoint, - Total days of hospital admission and re-admittance from day of surgery till 30 days postoperatively - Loss of kidney function > 20 ml/min at approximately 1 year postoperatively - The frequency of uretero-ileo anastomotic strictures at approximately 1 year postoperatively requiring secondary drainage or intervention | — |
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the UIA associated complication rate within 30 days postoperatively. This is a composite endpoint of the following complications: 1) Radiological or biochemical evidence of urinary tract leakage at the UIA defined as contract extravasation on computer tomography (CT) of the abdomen or elevated levels of creatinine in the fluid of the wound drain from the second day postoperatively and onwards, 2) Ureteral stricture or obstruction Abovementioned complications should require substantial prolonging of the wound drain, placement of a percutaneous drain in a urinoma, placement of a nephrostomy tube or secondary intervention. 3) Evidence/suggestion of upper urinary tract infection defined as a positive urine culture with symptoms such as of fever (T >= 38.5°C) , chills, groin pain, and/or elevation of inflammation parameters, which requires antibiotic treatment. Or evidence/suggestion of urinary tract sepsis defined as a positive urine and blood culture, with identical cultures | — |
Countries
Netherlands
Outcome results
None listed