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Splint-tial: Stent PLacement IN living kidney Transplantation

Prevention of urological complications in living kidney transplantation: stenting or not?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25009
Enrollment
200
Registered
2014-04-09
Start date
2014-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal transplant, live kidney donors, stent

Interventions

1. Intervention: No stent placement 2. Control: Stent placement

Sponsors

Prof. dr. J.N.M. IJzermans
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Number of PCN placements

Secondary

MeasureTime frame
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.

Contacts

Public ContactL.S.S. Ooms

Erasmus MC, University Medical Center Rotterdam Department of Surgery, Room Z-836

l.ooms@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)