Clinical trial NCT04494087: The Effect of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty on Information Providing: a Multicenter Randomized Controlled 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Keywords: inguinal hernia
informed consent
STAI
ICF
State-Trait Anxiety Inventory
Individual Clinician Feedback
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Score in multiple-choice-test
timeFrame: assessed 1-2 days after group allocation/exposure
Secondary outcomes:
measure: Spielberg State-Trait Anxiety Inventory (STAI)
timeFrame: assessed 1-2 days after group allocation/exposure
measure: Individual Clinician Feedback (ICF)
timeFrame: assessed 30 days postoperatively at follow-up visit
measure: Numerical rating scale (NRS)
timeFrame: assessed 3 months postoperatively
Other outcomes:
Locations:
city: Wetzikon
country: Switzerland
facility: GZO Spital Wetzikon
city: Winterthur
country: Switzerland
facility: Cantonal Hospital Winterthur, Department of Surgery
Study officials:
affiliation: Cantonal Hospital Winterthur, Department of Surgery
name: Christian Gingert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.