Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures

Completed

• Conditions: Informed Consent

• Registration Number: NCT03960723
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

The Informed Consent (IC) of a medical procedure is the aceptation of a diagnostic or therapeutic procedure by the patient, after receiving the necessary and accurate information about it. Freedom, information and understanding have to be the main requirements in this proccess.

The main goal of this study is to assess if patients that are going to be operated at Hospital de la Santa Creu i Sant Pau in the CSI (Surgery without previous hospitalization) unit, really understood the information about the procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-09
• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Primary Completion: 2019-12-09
• Study Completion: 2019-12-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Undergoing surgery and admitted by CSI unit
• Provide written informed consent to participate in the study

Exclusion Criteria

• Patients who need a legal representative to read, understand and sign the CI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Understanding degree	Before procedure	Assessment of the understanding degree of the IC by the patient

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain