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

NCT ID: NCT03960723

Last Updated: 2023-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-09

Study Completion Date

2019-12-09

Brief Summary

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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

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Conditions

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Informed Consent

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Questionnaire

A questionnaire asking the patients for several questions related to the Informed Consent Form they have signed before surgery, will be administered.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosa Mª Antonijoan Arbos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Recerca de l´Hospital de la Santa Creu i Sant Pau

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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IIBSP-CIP-2019-25

Identifier Type: -

Identifier Source: org_study_id

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