The Effect of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty on Information Providing: a Multicenter Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-18

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hernia video

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.

Group Type ACTIVE_COMPARATOR

Explanatory video

Intervention Type OTHER

Links to explanatory videos handed out to patients to be watched at home after standard informed consent giving

Mock video

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.

Group Type PLACEBO_COMPARATOR

Explanatory video

Intervention Type OTHER

Links to explanatory videos handed out to patients to be watched at home after standard informed consent giving

Control group

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.

Group Type SHAM_COMPARATOR

Informed consent form

Intervention Type OTHER

Links to a digital version of the informed consent form already discussed during the process of informed consent giving.

Interventions

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Explanatory video

Links to explanatory videos handed out to patients to be watched at home after standard informed consent giving

Intervention Type OTHER

Informed consent form

Links to a digital version of the informed consent form already discussed during the process of informed consent giving.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No