SURGIMEDIA: Utilization of Multimedia for Enhanced Surgical Consent

Starting soon · Not applicable

Conditions studied: Pancreas Cancer

In brief

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.

Key facts

Study ID

NCT07494994

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

60

Starts

2026-07-01

Expected to finish

2030-01-01

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Inability to speak English.
• Dementia altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent as determined by the study physician.
• Currently pregnant. If a participant becomes pregnant during the study, they will be withdrawn and replaced with a new participant if resources allow.

Where it is running

• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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