Informed Consent in Endoscopy: Read, Understood or Merely Signed?

Informed consent form is a legal document that, ethically, should be obtained before any endoscopic procedure is performed.

The main purpose of this research study is to assess the readability, comprehensibility and applicability of the new informed consent proposed by the Portuguese Society of Digestive Endoscopy as a way to standardize the information provided to patients prior to endoscopic exams.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Informed Consent Gastrointestinal Endoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Hospitalar Tondela Viseu

Viseu, 3504-509, Portugal

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Adult patients able to autonomously give informed consent
Patients refered to elective endoscopic procedures (upper digestive endoscopy and/or colonoscopy) without deep sedation.

Exclusion criteria

Patients refered to urgent endoscopic procedures
Patients refered for endoscopic procedures with deep sedation

Treatment and study plan

Reading of informed consent form

Behavioral

Patients that adequately read informed consent forms

Primary outcomes

Assessing the percentage of patients who adequate read informed consent forms

Time frame: 12 months

Assess if patients "adequately read" informed consent forms - "adequate reading" was defined by checking all of the following: signing of informed consent form; fulfilment of a questionnaire regarding medical history and drugs; underlining a small sentence added to the orignial version of informed consent form.

Patients not meeting all the defined criteria were considered not to have adequately read the informed consent.

Sponsors and collaborators

Lead sponsor

Centro Hospitalar Tondela-Viseu

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 10, 2022
Registry last updated: Jun 15, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed