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Splint-tial: Stent PLacement IN living kidney Transplantation


- candidate number17288
- NTR NumberNTR4498
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-apr-2014
- Secondary IDsMEC-2013-196 METC Erasmus MC
- Public TitleSplint-tial: Stent PLacement IN living kidney Transplantation
- Scientific TitlePrevention of urological complications in living kidney transplantation: stenting or not?
- ACRONYMSplint-trial
- hypothesisOur hypothesis is that a reduction of urological complications in living kidney transplantation can be achieved without stent placement
- Healt Condition(s) or Problem(s) studiedRenal transplant , Stent
- Inclusion criteriaParticipants who will receive a living donor kidney transplantation and speak the Dutch language sufficiently to sign the informed consent forms and to fill in the questionnaires
- Exclusion criteria• Patients with a reconstructed urinary tract or conduit after total or partial cystectomy. • Patients with bladder dysfunction that requires continuous or intermittent catheterization. • Age <18 years • Donor kidneys with more than one ureter
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2014
- planned closingdate1-mrt-2016
- Target number of participants200
- Interventions1. Intervention: No stent placement 2. Control: Stent placement
- Primary outcomeNumber of PCN placements
- Secondary outcomeUrinary tract infection, Haematuria, Radiological interventions, Surgical re-interventions, Stent obstruction or dysfunction. Additionally, a quality of life and cost effectiveness analysis will be preformed with questionnaires. Validated questionnaires for quality of life, health state, work efforts and disabilities in daily life are measured by the Euro-Qol, SF-36 and ‘Werk en Zorg’. Other study parameters are baseline values, which might intervene with the main study parameter: donor age and gender, recipient age and gender, body mass index, smoking, ASA classification, operation time and return to normal daily activities.
- TimepointsFollow-up will be 1 year
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. L.S.S. Ooms
- CONTACT for SCIENTIFIC QUERIESDr. T. Terkivatan
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summaryUrological complications after kidney transplantation are associated with significant morbidity, mortality, prolonged hospital stay and a radiological intervention or second surgical procedure is frequently required. The majority of urological complications are related to the ureteroneocystostomy and a first sign is often placement of a percutaneous nephrostomy (PCN) drain. It has been suggested that routine use of a prophylactic ureteral stent (splint) in kidney transplantation may diminish the risk of urological complications. However, the role of ureteral stents in living donor kidney transplantation is not well defined and there is concern about potential stent related complications as infection, obstruction, stent migration, breakage, stone formation, haematuria, and secondary ureter obstruction.The aim of this study is to assess the rate of urological complications in patients with and without stent placement in live kidney transplantation.
- Main changes (audit trail)
- RECORD9-apr-2014 - 27-apr-2014


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