No registrations found.
ID
Source
Brief title
Health condition
renal transplant, live kidney donors, stent
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of PCN placements
Secondary outcome
Urinary 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.
Background summary
Urological 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.
Study objective
Our hypothesis is that a reduction of urological complications in living kidney transplantation can be achieved without stent placement
Study design
Follow-up will be 1 year
Intervention
1. Intervention: No stent placement
2. Control: Stent placement
Department of Surgery, Room Z-836
L.S.S. Ooms
Rotterdam
The Netherlands
l.ooms@erasmusmc.nl
Department of Surgery, Room Z-836
L.S.S. Ooms
Rotterdam
The Netherlands
l.ooms@erasmusmc.nl
Inclusion criteria
Participants 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
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 |
|---|---|
| NTR-new | NL4358 |
| NTR-old | NTR4498 |
| Other | METC Erasmus MC : MEC-2013-196 |