Informed Consent in Endoscopy: Read, Understood or Merely Signed?
- Conditions
- Gastrointestinal EndoscopyInformed Consent
- Registration Number
- NCT05414435
- Lead Sponsor
- Centro Hospitalar Tondela-Viseu
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 232
- Adult patients able to autonomously give informed consent
- Patients refered to elective endoscopic procedures (upper digestive endoscopy and/or colonoscopy) without deep sedation.
- Patients refered to urgent endoscopic procedures
- Patients refered for endoscopic procedures with deep sedation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessing the percentage of patients who adequate read informed consent forms 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centro Hospitalar Tondela Viseu
🇵🇹Viseu, Portugal