Status:
RECRUITING
Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Spine Disease
Urologic Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an interventional, non-pharmacological, randomized controlled superiority study (RCT), multicenter, open label, parallel group. The aim is to evaluate the effectiveness of a new preoperative ...
Eligibility Criteria
Inclusion
- Adults aged ≥ 18 years (with full legal capacity to consent).
- Scheduled for elective surgery in one of the two domains: spinal surgery or radical prostatectomy in the waiting list of our centers.
- Ability to comprehend Italian language.
- Basic computer or internet access skills. Patients (or their family members) should have the ability to access multimedia content.
Exclusion
- Patients under age: minors.
- Inability to provide informed consent or self-determination (significant cognitive impairment, severe mental illness, or decisional incapacity that would prevent them from understanding the consent materials or participating in the decision-making).
- Urgent or emergency surgery cases.
Key Trial Info
Start Date :
June 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06059599
Start Date
June 19 2024
End Date
October 1 2026
Last Update
December 9 2025
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136