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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04494087
• Other study ID #: 2020-01548
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: September 2023

Study information

• Verified date: October 2022
• Source: Kantonsspital Winterthur KSW
• Contact: Fabian Lunger, MD,PhD
• Phone: +41 052 266 21 21
• Email: fabian.lunger[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 183
• Est. completion date: September 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Other:
• Explanatory video
Links to explanatory videos handed out to patients to be watched at home after standard informed consent giving
• Informed consent form
Links to a digital version of the informed consent form already discussed during the process of informed consent giving.

Locations

Country	Name	City	State
Switzerland	GZO Spital Wetzikon	Wetzikon
Switzerland	Cantonal Hospital Winterthur, Department of Surgery	Winterthur

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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