The Effect of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty on Information Providing: a Multicenter Randomized Controlled Trial
Potential Benefit in Information Providing and Influence on Patient Anxiety and Satisfaction by Means of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty: a Multicenter Randomized Controlled Trial
Lead Sponsor: Kantonsspital Winterthur KSW
|Source||Kantonsspital Winterthur KSW|
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, the investigators 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.
In a multi-center setup, eligible patients for primary inguinal hernia repair will be randomly assigned to 1 of 3 groups. 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. The third group's link will lead to the digital version of the informed consent. 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 (STAI) and 3) patient satisfaction questionnaire (ICF, Picker Institute, Germany) as assessed 1-2 days after the first consultation.
|Overall Status||Not yet recruiting|
|Start Date||September 2020|
|Completion Date||July 2022|
|Primary Completion Date||July 2021|
Intervention Type: Other
Intervention Name: Explanatory video
Description: Links to explanatory videos handed out to patients to be watched at home after standard informed consent giving
Intervention Type: Other
Intervention Name: Informed consent form
Description: Links to a digital version of the informed consent form already discussed during the process of informed consent giving.
Arm Group Label: Control group
Inclusion Criteria: - unilateral or bilateral hernia with indication for surgical therapy - signed informed consent form for trial participation Exclusion Criteria: - Patients who have had surgery for ipsi- or contralateral inguinal or femoral hernia - combination interventions (umbilical and inguinal hernia repair, e.g.) - cognitive, audio-visual or linguistic handicap raising concern of complete understanding of the research project
- unilateral or bilateral hernia with indication for surgical therapy
- signed informed consent form for trial participation
- Patients who have had surgery for ipsi- or contralateral inguinal or femoral hernia
- combination interventions (umbilical and inguinal hernia repair, e.g.)
- cognitive, audio-visual or linguistic handicap raising concern of complete understanding of the research project
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Last Name: Fabian Lunger, MD,PhD
Phone: +41 052 266 21 21
Email: [email protected]
|Has Expanded Access||No|
|Number Of Arms||3|
Label: Hernia video
Type: Active Comparator
Description: The video of the intervention group will provide a short (< 5 min) summary explaining the basic principles of endoscopic extraperitoneal hernia repair, its possible complications and the postoperative course. After carefully watching the video, participants should be able to correctly answer to a multiple-choice test consisting of 12 questions related to the aforementioned topics.
Label: Mock video
Type: Placebo Comparator
Description: This video is a general documentation of the "typical" day of surgery in the day clinic. The information is essentially limited to the pictorial representation of the individual wards which the patient will pass through during the operation (arrival at the clinic, admission, transport to the operating theatre, recovery room, discharge). The video explicitly does not transport any information that could be helpful for answering the quiz questions or for medical understanding of the operation itself.
Label: Control group
Type: Sham Comparator
Description: The link of the third group leads to a digital version of the information sheet, which has already been discussed with all patients during the informed consent discussion. The digital version of the informed consent form allows the patient to read the information again. The third group thus corresponds to the standard of care.
|Study Design Info||
Intervention Model: Parallel Assignment
Primary Purpose: Health Services Research
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)