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Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals

Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals

Recruiting
18 years and older
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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 information method, based on multimedia tools and on the objective control of understanding by the patient candidate for spinal or urological surgery.

Eligibility

Inclusion Criteria:

  • Age ≥ 18 years
  • Presence on waiting list for planned spinal (instrumented vertebral arthrodesis) and urological (radical prostatectomy) surgeries
  • Understanding of the Italian language (in fact, it is believed that the percentage of non
  • Italian mother-tongue patients is minimal and therefore not impacting the study)
  • Ability to access computer tools -

Exclusion Criteria:

  • Age < 18 years
  • Inability to self-determine
  • Urgency/emergency of intervention

Study details
    Spine Disease
    Urologic Diseases

NCT06059599

Istituto Ortopedico Rizzoli

15 October 2025

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