Introduction
The use of electronic media in informed consent giving has become
increasingly important in recent years. Due to the easy access to
information via electronical media, patients are primed in a
heterogeneous manner concerning expectations and wishes regarding
surgical interventions. Inherent to its nature elective interventions
are critically questioned as there is time for information gathering and
reflection. In this study, we set out to investigate the effect of an
educational video as a supporting element in the process of informed
consent giving for one the most frequently performed interventions in
general surgery, namely inguinal hernia repair.
Methods and analysis
In a multicentre setup, eligible patients for primary inguinal
hernia repair will be randomly assigned to one of three groups. All
three groups will have a preoperative informed consent discussion with a
physician in which they will eventually sign the informed consent sheet
if participation is desired. Eventually, all three groups will get an
online link. For two groups, the link will lead to a video with
audiovisual information (an inguinal hernia video for the intervention
group and a mock video for the control group). The intervention video
provides basic principles of endoscopic extraperitoneal hernia repair.
The second video is similar in length and design and displays general
aspects of day surgery in the two study centres. All the three study
groups will be provided with a copy of the informed consent form as it
is standard by now. The third group’s link will lead to the digital
version of the informed consent brochure. Primary outcomes will consist
of (1) score in a multiple choice test assessing gain of knowledge
regarding hernia repair, (2) difference in the State-Trait Anxiety
Inventory and (3) patient satisfaction questionnaire Individual
Clinician Feedback (ICF, Picker Institute, Germany) as assessed 1–2 days
after the first consultation. The study design guarantees double
blinding, there will be no unblinding at any point. All patients will
receive the same, quality and number of medical consultations as well as
in the same surgical treatment. (Minor differences in the total
extraperitoneal technique of the surgical treatment due to anatomical or
pathophysiological differences are independent of the group allocation).
Except for the additional videos, there will be no difference in in the
information provided and the treatment prior, during or after the hernia
repair.
Ethics and dissemination
We plan to publish the study in a peer-reviewed journal. The
proposed research project has been reviewed by the Cantonal Ethics
Committee (BASEC-No 2020–01548). In accordance with national legal
regulations in Switzerland stated by the Human Research Act, the
proposed project was declared exempt from approval requirement.
Trial registration number
NCT04494087; Pre-results.