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Informed Consent Procedures in Live Donor Nephrectomy


- candidate number22778
- NTR NumberNTR5374
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-aug-2015
- Secondary IDsMEC-2014-538 
- Public TitleInformed Consent Procedures in Live Donor Nephrectomy
- Scientific TitleProcess of Informed Consent Evaluation in Potential Living Kidney Donors
- ACRONYMPRINCE
- hypothesisInformed consent procedures and information provision differs between different transplantation centers and transplantation professionals in The Netherlands. Donor knowledge and satisfaction may be influenced by the manner of information provision and the contents of the informed consent procedure.
- Healt Condition(s) or Problem(s) studiedLive kidney donors
- Inclusion criteria- Potential living kidney donor
- Age ≥ 18 years
- Fluent comprehension of Dutch language
- Exclusion criteria- Mental illness prohibiting consent
- No fluent comprehension of Dutch language
- Minor (<18 years of age)
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 30-mrt-2015
- planned closingdate30-mrt-2016
- Target number of participants600
- Interventions- Pop-quiz style knowledge tests
- Satisfaction & evaluation questionnaire
- Primary outcome- Donor comprehension of the donation procedure
- Elements to be included in standardized informed consent procedure
- Secondary outcome- The manner of obtaining consent in the eight Dutch transplant centers
- Donor satisfaction with the informed consent procedure
- Correlation of donor comprehension with surgeons'estimate thereof
- TimepointsThere are no explicit timepoints. Inclusion is expected to be finalized by march 30th 2016.
- Trial web sitenot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. F.J.M.F. Dor
- CONTACT for SCIENTIFIC QUERIESDr. F.J.M.F. Dor
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Stichting Kwaliteitsgelden Medisch Specialisten, Nierstichting
- Publications
- Brief summaryThe PRINCE trial aims to evaluate the current status of the informed consent procedure for the live donor Nephrectomy in the Netherlands. Donor comprehension will be assessed by means of pop quizzes and an evaluation and satisfaction questionnaire will be provided to them. Data collected in this project will be used to create a standardized format for the informed consent procedure for the live donor nephrectomy.
- Main changes (audit trail)
- RECORD21-aug-2015 - 26-aug-2015


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