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

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.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia
• Intervention / Treatment: Other: Explanatory video; Other: Informed consent form

• Study Type: Interventional
• Enrollment (Anticipated): 183
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabian Lunger, MD,PhD; Phone Number: +41 052 266 21 21; Email: fabian.lunger@gmail.com

Study Locations

• Switzerland
  • Wetzikon, Switzerland, 8620
    • Recruiting
    • GZO Spital Wetzikon
  • Winterthur, Switzerland, 8400
    • Recruiting
    • Cantonal Hospital Winterthur, Department of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Explanatory video; Links to explanatory videos handed out to patients to be watched at home after standard informed consent giving
Placebo Comparator: 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.	Other: Explanatory video; Links to explanatory videos handed out to patients to be watched at home after standard informed consent giving
Sham Comparator: 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.	Other: Informed consent form; Links to a digital version of the informed consent form already discussed during the process of informed consent giving.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score in multiple-choice-test	Quiz with questions regarding background, indication, implementation, complications and postoperative course of the total extraperitoneal inguinal h ernioplasty (TEP) procedure. The questions asked check relevant aspects for the patient with regard to the planned operation. The structure of the multiple-choice quiz takes the "single best option" out of 12 questions. Maximum value of the test is 12 (12/12, highest score-best outcome), the lowest 0 (0/12, lowest score-worst outcome). The questions are clearly posed and the correct answer is based on current guidelines for the management of inguinal hernia, which have been published by the European Hernia Society (EHS), American Hernia Society (AHS), International Endo Hernia Society (IEHS) and the European Association for Endoscopic Surgery and Other Interventional Techniques (EAES) as a consensus document by "HerniaSurge".	assessed 1-2 days after group allocation/exposure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spielberg State-Trait Anxiety Inventory (STAI)	To test the effect of the intervention on anxiety before surgery, an anxiety score is determined using the Spielberg State-Trait Anxiety Inventory (STAI). The inventory is based on a 4-point Likert scale and consists of 40 questions on a self-report basis. Scores range from 20 to 80 with higher scores indicating greater anxiety.	assessed 1-2 days after group allocation/exposure
Individual Clinician Feedback (ICF)	Patient satisfaction with regard to doctor-patient communication is recorded by the validated ICF questionnaire. The ICF questionnaire (Picker Institute) comprises 38 items concerning the patient's experience of the examination atmosphere, the comprehensibility of the physician's statements, the participation in decisions, the course of the conversation as well as socio-demographic characteristics of the patient. The items are assessed on an 11-point Likert scale from 0 to 10, with 0 as the most critical and 10 as the most positive experience.	assessed 30 days postoperatively at follow-up visit
Numerical rating scale (NRS)	To assess the effect on chronic pain, the pain is assessed by telephone using the NRS score approximately 3 months after the operation. The numerical rating scale (NRS) requires the patient to rate his or her pain on a scale from 0 to 10, in which 0 is no pain (best outcome) and 10 the worst pain imaginable (worst outcome).	assessed 3 months postoperatively

Collaborators and Investigators

• Sponsor: Kantonsspital Winterthur KSW
• Investigators: Principal Investigator: Christian Gingert, MD, Cantonal Hospital Winterthur, Department of Surgery

Publications and helpful links

General Publications

• Lunger F, Frank F, Peros G, Lunger A, Vuille-Dit-Bille R, Guglielmetti L, Breitenstein S, Grieder F, Ehlers J, Gingert C. Potential benefit in information providing and influence on patient anxiety and satisfaction by means of preoperative explanatory videos in total extraperitoneal inguinal hernioplasty: study protocol of a multicentre, double-blinded, randomised parallel-group controlled trial. BMJ Open. 2021 Jan 26;11(1):e043702. doi: 10.1136/bmjopen-2020-043702.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: ICF; STAI; informed consent; inguinal hernia; State-Trait Anxiety Inventory; Individual Clinician Feedback
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 2020-01548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share individual participant data (IPD) with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No