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Clinical Trials/NCT03960723
NCT03960723
Completed
Not Applicable

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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country300 target enrollmentMay 9, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Informed Consent
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment
300
Locations
1
Primary Endpoint
Understanding degree
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 9, 2019
End Date
December 9, 2019
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Understanding degree

Time Frame: Before procedure

Assessment of the understanding degree of the IC by the patient

Study Sites (1)

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