|- candidate number||8051|
|- NTR Number||NTR2320|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mei-2010|
|- Secondary IDs||MEC-2009-385 METC Erasmus MC|
|- Public Title||Urological complications after live donor kidney transplantation: Intravesical or extravesical ureterovesical anastomosis?
|- Scientific Title||Urological complications after live donor kidney transplantation: Intravesical or extravesical ureterovesical anastomosis?
|- hypothesis||Our hypothesis is that the extravesical technique reduces the incidence of PCN placement, and urological complications.|
|- Healt Condition(s) or Problem(s) studied||Renal transplant , Renal disease, Live kidney donors|
|- Inclusion criteria||All kidney transplant recipients from a living donor, who are medically able to receive a kidney, can participate. |
|- Exclusion criteria||1. Recipients younger than 18 years;|
2. Donor kidneys with more than one ureter.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2010|
|- planned closingdate||1-jun-2012|
|- Target number of participants||200|
|- Interventions||1. Intervention: Extravesical ureterovesical anastomosis technique;|
2. Control: Intravesical ureterovesical anastomosis technique.
|- Primary outcome||Number of PCN placements by use of the extravesical ureterovesicostomy. |
|- Secondary outcome||1. Number of re-operations and re-interventions for urological complications;|
2. Operation time;
|- Timepoints||Follow-up will be 1 year.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. I.K.B. Slagt|
|- CONTACT for SCIENTIFIC QUERIES||Dr. T. Terkivatan|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Mrace Comittee, Erasmus MC|
|- Brief summary||Urological complications after renal transplantation cause significant patient morbidity and may result in transplant failure. 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 extravesical technique. In our center the standard technique is the intravesical technique. In case an urological complication (e.g. ureteral stenosis) occurs after transplantation, we might decide to place a percutaneous nephrostomy catheter (PCN). PCN can therefore been 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, in order to determine which anastomosis technique has the least urological complications.
|- Main changes (audit trail)|
|- RECORD||10-mei-2010 - 10-mrt-2013|