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Recruiting NCT06059599

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

No phase Interventional Spine Disease Urologic Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: active informed consent.
Who it may be relevant to
Registry conditions: Spine Disease, Urologic Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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.

Primary outcome measures

  • Client Satisfaction Questionnaire [Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)]
Secondary outcome measures (9)
  • Comprehension Questionnaire [Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)]
  • Depression Anxiety Stress Scales (DASS-21) [Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)]
  • Numeric Rating Scale (NRS) [Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)]
  • Oswestry Disability Index (ODI) [Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)]
  • International Prostate Symptom Score (IPSS) [Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)]
  • 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)]
  • International Index of Erectile Function (IIEF-5 ) [Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)]
  • Rate of Patients Declining Spine Surgery (Opt-Out Rate) [Time frame: baseline (T0)]
  • Medico-Legal Outcomes [Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Italy · 1 center
  • Istituto Ortopedico Rizzoli — Bologna

Publications

  • Kinnersley P, Phillips K, Savage K, Kelly MJ, Farrell E, Morgan B, Whistance R, Lewis V, Mann MK, Stephens BL, Blazeby J, Elwyn G, Edwards AG. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database Syst Rev. 2013 Jul 6;2013(7):CD009445. doi: 10.1002/14651858.CD009445.pub2. PMID 23832767
  • Glaser J, Nouri S, Fernandez A, Sudore RL, Schillinger D, Klein-Fedyshin M, Schenker Y. Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review. Med Decis Making. 2020 Feb;40(2):119-143. doi: 10.1177/0272989X19896348. Epub 2020 Jan 16. PMID 31948345
  • Nathe JM, Krakow EF. The Challenges of Informed Consent in High-Stakes, Randomized Oncology Trials: A Systematic Review. MDM Policy Pract. 2019 Mar 28;4(1):2381468319840322. doi: 10.1177/2381468319840322. eCollection 2019 Jan-Jun. PMID 30944886
  • Luhnen J, Muhlhauser I, Steckelberg A. The Quality of Informed Consent Forms-a Systematic Review and Critical Analysis. Dtsch Arztebl Int. 2018 Jun 1;115(22):377-383. doi: 10.3238/arztebl.2018.0377. PMID 29932049
  • Boriani L, Quattrini I, Maccaferri B, Lima C, Benuzzi A, Salvador M, Schiavina R, Brunocilla E, Deiure F, Maselli V, De Stefano R, Vommaro F, Gasbarrini A. Protocol RCT for active informed consent in spine and urologic surgery in the metropolitan city of Bologna: does an increased patient engagement improve satisfaction of complex surgical procedures? BMJ Open. 2026 Mar 10;16(3):e108286. doi: 10.1 PMID 41806994

Identifiers

NCT: NCT06059599 · CIA21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗