Main objective: Does the use of the extravesical ureterovesicostomy reduce the incidence of PCN placement, and urological complications?Secondary objective: Does the use of the extravesical ureterovesicostomy reduces the rate of re-operations and re…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint
A change from 22% to 7% PCN placement by use of the extravesical
ureterovesicostomy.
Secondary outcome
Secondary study parameters/endpoints
Does the use of the extravesical ureterovesicostomy reduces the rate of
re-operations and re-interventions for urological complications, and reduces
operation time and costs.
Other study parameters
Other study parameters are baseline values, which might intervene with the main
study parameter: age, recipient, donor age gender, BMI, smoking, ASA
classification, side of the procured kidney, number of renal arteries and
number of renal veins.
Background summary
Urological complications after renal transplantation cause significant patient
morbidity and may result in transplant failure. The risk of urological
complications after kidney transplantation is as high as 2.5% up to 30%. The
majority of urological complications is related to the ureterovesical
anastomosis and occurs within 3 months after transplantation.
Successful formation of the ureterovesical anastomosis is important in
preventing complications and securing a functional transplant. Several
techniques for ureterovesical anastomosis are described, with variable outcome.
The surgical protocol for transplant ureteroneocystostomy has oscillated
between intravesical and extravesical procedures. No technique has been
convincingly proven to be superior to the other, although some studies suggest
the superiority of the extra-vesical technique; the extravesical technique
requires a shorter length of ureter, which may decrease the risk of distal
ureteric ischemia, and a separate cystotomy is not required. In our center the
standard technique is the intra-vesical technique with placement of a supra
pubic stent in the pyelum of the donor kidney. Approximately 22% of the
recipients of a live kidney donation receive a percutaneous nephrostomy
catheter (PCN) for urological complications. PCN can be seen as a measure for
the urological complications.
The aim of this study is to assess the rate of percutaneous nephrostomy (PCN)
placement for urological complications in patients with an intra and
extravesical ureterovesical anastomosis in live kidney transplantation. We
hypothesize that extravesical technique reduces the incidence of PCN placement,
and urological complications.
Study objective
Main objective: Does the use of the extravesical ureterovesicostomy reduce the
incidence of PCN placement, and urological complications?
Secondary objective: Does the use of the extravesical ureterovesicostomy
reduces the rate of re-operations and re-interventions for urological
complications, and reduces operation time and costs.
Study design
Dubbel blind randomized controlled trial.
Intervention
Intravesical ureterovesicostomy was performed after graft vascularization via
an anterior cystotomy to visualize the interior of the bladder. Briefly, this
consisted of a small anterior cystostomy and the spatulated lower ureter was
anastomosed to the bladder mucosa with interrupted sutures.
Extravesical ureterovesicostomy was performed after graft vascularization. The
donor ureter length was modified to avoid redundancy and was usually shorter
than that needed for an intravesical approach. A myotomy was made with cautery
on the anterolateral surface of the bladder. This incision was continued
through the seromuscular layer until mucosa bulged through. The ureter was
trimmed and the full thickness of the ureter was anastomosed to the bladder
mucosa beginning with two-quadrant interrupted sutures. The sutures were used
to complete the anastomosis in a running fashion between each quadrant stay
suture, creating a water-tight closure. During both techniques a supra pubic
stent is placed in the donor pyelym. In addition three kidney biopsies are
taken in each patient and send to the pathologist until further analysis for
possible ischemia, inflammation etc.
Study burden and risks
The burden and risks associated with participation is limited to one of the two
surgical techniques of ureterovesicostomy and to the perioperative kidney
biopsies. The amount and number of blood samples, the number of site visits and
physical examinations is the same as in a standard work-up of a kidney
transplant recipient.
's-Gravendijkwal 230
3000 CA Rotterdam
NL
's-Gravendijkwal 230
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria: All kidney transplant recipients from a living donor, who are medically able to receive a kidney, can participate. Recipients must be older than 18 years.
Exclusion criteria
Exclusion criteria: Donorkidneys with more than one ureter and recipients younger than 18 years.
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 | NL29527.078.09 |