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

NCT06059599 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-02-02

No results posted yet for this study

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

Conditions

  • Spine Disease
  • Urologic Diseases

Interventions

OTHER

active informed consent

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

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-19
Primary Completion
2026-09-30
Completion
2026-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06059599 on ClinicalTrials.gov