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

Sponsors

Lead Sponsor: Kantonsspital Winterthur KSW

Source Kantonsspital Winterthur KSW
Brief Summary

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
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Score in multiple-choice-test assessed 1-2 days after group allocation/exposure
Secondary Outcome
Measure Time Frame
Spielberg State-Trait Anxiety Inventory (STAI) assessed 1-2 days after group allocation/exposure
Individual Clinician Feedback (ICF) assessed 30 days postoperatively at follow-up visit
Numerical rating scale (NRS) assessed 3 months postoperatively
Enrollment 183
Condition
Intervention

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

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Christian Gingert, MD Principal Investigator Cantonal Hospital Winterthur, Department of Surgery
Overall Contact

Last Name: Fabian Lunger, MD,PhD

Phone: +41 052 266 21 21

Email: [email protected]

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Health Services Research

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov