DUET-trial; DoUble j or External stenting during kidney Transplantation? Study-protocol
Recruiting
- Conditions
- Urological complications after kidney transplantatie1004659010038365
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
All adult kidney transplant recipients that will be transplanted at the Erasmus University Medical Center (>18yrs) are invited to participate.
Exclusion Criteria
Patients will be excluded if they do not understand the Dutch language sufficiently to sign the informed consent forms and to fill in the questionnaires, or if they have a reconstructed urinary tract or conduit after total or partial cystectomy, a bladder dysfunction that requires continuous or intermittent catheterization, or will receive a donor kidney with more than one ureter. In addition, patients with primary FSGS and residual urine production will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Our main study endpoint is the number of percutaneous nephrostomy (PCN)<br /><br>drainages. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameters are the number of urinary tract infections,<br /><br>macroscopic haematuria, radiological interventions, surgical re-interventions<br /><br>and stent obstruction or dysfunction. Additionally, a quality of life and cost<br /><br>effectiveness analysis will be performed by using questionnaires. Validated<br /><br>questionnaires for pain, quality of life, health state, work efforts and<br /><br>disabilities in daily life are measured by the VAS, Euro-Qol, SF-36 and *Werk<br /><br>en Zorg*.</p><br>