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OpenTrials
Completed

NCT Number: NCT03960723

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

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.

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Key information

Conditions

Informed Consent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. Understanding degree

    Time frame: Before procedure

    Assessment of the understanding degree of the IC by the patient

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 23, 2019
Registry last updated
Sep 25, 2023

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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