NCT07494994Not yet recruiting
SURGIMEDIA: Utilization of Multimedia for Enhanced Surgical Consent
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
Informed consent is an ethical and legal component of the pre-procedural process. Informed consent involves the explanation of procedural steps and discussion regarding the risks, benefits, and alternatives of the proposed procedure. The current informed consent process lacks standardization, and patient experience can vary widely depending on the provider obtaining consent. This pilot study aims to ensure high quality informed consent for patients undergoing a complex oncologic operation known as a pancreaticoduodenectomy (Whipple operation), through the creation of an educational video as a method of obtaining informed consent. This study will explore whether the application of an educational video as part of the informed consent process increases patient understanding, comfort, and overall satisfaction throughout the Whipple operative course. The primary objective of this study is to determine whether implementation of a multimedia video as an enhancement to surgical informed consent improves patient satisfaction, promotes understanding, and informs operative expectations. The desired outcome is to standardize the informed consent process to eliminate variability in the quality of the consent process and to mitigate the impact of healthcare barriers such as health literacy and language proficiency in the informed consent process.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 20 Mar 2026
- Start date
- Sept 2026
- Primary completion date
- Jan 2030
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Pancreatic cancer
- NCT number
- NCT07494994
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Sept 2026 to the primary completion date, Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Dementia altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent as determined by the study physician.
Other
- Inability to speak English.
- Currently pregnant. If a participant becomes pregnant during the study, they will be withdrawn and replaced with a new participant if resources allow.
Who the study is looking for
- Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
- Subjects is willing and able to comply with study procedures based on the judgement of the investigator.
- Age ≥ 18 years at the time of informed consent for study participation.
- Scheduled to undergo a standard of care pancreaticoduodenectomy procedure.
- English as the patient's self-reported preferred language.
Criteria the registry did not label
- In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.