To assess whether the omission of IOS placement in patients undergoing cystectomy and ileal urinary conduit results in a similar per patient event-free 30-day survival rate as compared to those who receive regular IOS placement.
ID
Source
Brief title
Condition
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary outcome
- 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
Background summary
Scientific evidence for the hypothesis that intra-operative ureteric stent
(IOS) placement on ileal urinary conduit improves the alignment of the
uretero-ileal anastomosis is lacking. Current literature even suggests that the
omission of IOS placement would result in a decrease of the incidence of
urinary tract related complications.
Study objective
To assess whether the omission of IOS placement in patients undergoing
cystectomy and ileal urinary conduit results in a similar per patient
event-free 30-day survival rate as compared to those who receive regular IOS
placement.
Study design
A multicenter, prospective randomized clinical trial
Intervention
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 routine IOS placement (standard of
care), or no IOS placement (study group
Study burden and risks
No extra site visits are needed. Regular care is performed in all patients,
also when treatment of complications is concerned. It is assumed that patients
in the study group have similar outcomes in the SOC group with respect to the
primary (and secondary) outcome variables. Though, there might be small chance
that patients in the study group do worse with respect to the incidence of
complications.
De Boelelaan 1117
Amsterdam 1007MB
NL
De Boelelaan 1117
Amsterdam 1007MB
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76874.029.21 |