NCT04494087

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 183 (estimated)
• Sponsor: Kantonsspital Winterthur KSW · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inguinal Hernia

Interventions

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

Timeline

• Start date: 2022-05-18
• Primary completion: 2023-05-01
• Completion: 2023-09-01
• First posted: 2020-07-31
• Last updated: 2022-10-28

Locations

2 sites across 1 country: Switzerland