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Clinical Trial Summary

The general objective of the study is to assess whether the new smartconsent tool improves patients' understanding of the intervention to be performed, compared to standard practice. A randomized clinical trial will be conducted in 50 patients who will undergo LASER PROSTATIC ENUCLEATION.


Clinical Trial Description

Male patients aged between 50 and 70 years, belonging to the Hospital Universitario Araba who are going to undergo PROSTATIC LASER ENUCLEATION, and who attend urology consultation between December 2019 and December 2020, and who meet the inclusion criteria and none of the exclusion criteria. Inclusion criteria: - Patients willing to receive information via tablet. - Patients who know how to and can read. Exclusion criteria: -Not applicable. Main variable: score on the Multiple choice test questionnaire (designed specifically for each type of procedure, following the recommendations proposed by Kehoe, Jerard and Fathelrahman et al. and developed on the basis of the information that an informed consent should provide (1, 2), with 4 response options and only one correct answer. An average score will be calculated for each patient. This test evaluates the comprehension of the information provided through the informed consent. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04856943
Study type Interventional
Source Bioaraba Health Research Institute
Contact RAQUEL COBOS
Phone +34945207935
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date December 31, 2021
Completion date December 31, 2021

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