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NCT Number: NCT06059599

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

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.

Recruiting

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Key information

Conditions

Spine Disease Bone Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Musculoskeletal Diseases Spinal Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Alessandro Gasbarrini, MD

SUB_INVESTIGATOR

Cristiana Griffoni, PhD

CONTACT

[email protected]

+39-0516366971

Giovanni Barbanti Brodano, MD

SUB_INVESTIGATOR

Gisberto Evangelisti, MD

SUB_INVESTIGATOR

Giuseppe Tedesco, MD

SUB_INVESTIGATOR

Riccardo Ghermandi, MD

SUB_INVESTIGATOR

Silvia Terzi, MD

PRINCIPAL_INVESTIGATOR

Stefano Bandiera, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

active informed consent

Other

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

Primary outcomes

  1. Client Satisfaction Questionnaire

    Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

    The primary outcome of the study will be measured: - by means of the Client Satisfaction Questionnaire, which provides a patient satisfaction score with a range from a minimum of 8 points (completely dissatisfied) to a maximum of 32 points (completely satisfied).

Secondary outcomes

  1. Comprehension Questionnaire

    Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

    procedure-specific assessment tool designed ad-hoc to evaluate a patient's knowledge and understanding of the planned procedure and associated risks/alternatives.

  2. Depression Anxiety Stress Scales (DASS-21)

    Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

    is a 21-item self-report questionnaire designed to assess the severity of depression, anxiety, and stress symptoms over the past week

  3. Numeric Rating Scale (NRS)

    Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

    is a simple self-report measure in which patients rate their current pain intensity on an scale from 0 ("no pain") to 10 ("worst imaginable pain").

  4. Oswestry Disability Index (ODI)

    Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

    self-administered questionnaire that assesses the degree of disability and functional impairment across ten daily-activity domains.

  5. International Prostate Symptom Score (IPSS)

    Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

    Only for Urology patients: 7-item questionnaire that evaluates the severity of lower urinary tract symptoms and their impact on quality of life.

  6. International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)

    Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

    Only for Urology patients: short, patient-completed questionnaire that measures the frequency, severity, and impact of urinary incontinence on quality of life.

  7. International Index of Erectile Function (IIEF-5 )

    Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

    Only for Urology patients: brief, 5-item self-report measure used to assess erectile function and screen for erectile dysfunction severity

  8. Rate of Patients Declining Spine Surgery (Opt-Out Rate)

    Time frame: baseline (T0)

    The proportion of patients in spine surgery population, who, after receiving full information, choose not to proceed with the planned surgery.

  9. Medico-Legal Outcomes

    Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3).

    For each group, we will track through hospital records the number of medicolegal complaints or claims filed by patients, specifically those alleging inadequate informed consent or unexpected outcomes, related to their surgery within the follow-up period. The outcome will be reported as the count (or proportion of patients) with such complaints in each arm.

Study contacts

Contact information is provided by the study sponsor or research team.

Bruna Maccaferri, MD

CONTACT

[email protected]

0516366163

Luca Boriani, MD

CONTACT

[email protected]

0516366233

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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