Inguinal HerniaNCT04494087
The Effect of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty on Information Providing: a Multicenter Randomized Controlled Trial
A study testing Explanatory video and Informed consent form in people with Inguinal Hernia, run by Kantonsspital Winterthur KSW at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Explanatory video and Informed consent form
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 18 May 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral or bilateral hernia with indication for surgical therapy
- signed informed consent form for trial participation
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Recruiting
GZO Spital Wetzikon
Wetzikon, 8620
- Recruiting
Cantonal Hospital Winterthur, Department of Surgery
Winterthur, 8400
About this study
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
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
- Being tested
- Explanatory video, Informed consent form
- Keywords
- inguinal hernia, informed consent, STAI, ICF, State-Trait Anxiety Inventory, Individual Clinician Feedback
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explanatory videoOther
Links to explanatory videos handed out to patients to be watched at home after standard informed consent giving
Informed consent formOther
Links to a digital version of the informed consent form already discussed during the process of informed consent giving.
| Study group | Role | What they receive |
|---|---|---|
| Hernia video | Active comparator | 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. Receives: Other: Explanatory video |
| Mock video | Placebo comparator | 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. Receives: Other: Explanatory video |
| Control group | Sham comparator | 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. Receives: Other: Informed consent form |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: assessed 1-2 days after group allocation/exposure
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: assessed 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start18 May 2022
- Primary completionMay 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Gingert, MD, Principal investigator, Cantonal Hospital Winterthur, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494087
- Sponsor's protocol ID
- 2020-01548
- Status last verified
- Oct 2022
- First submitted
- 13 Jul 2020
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) with other researchers.
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.
PubMed 33500291
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04494087
- Acronym / sponsor ID
- 2020-01548
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia, informed consent, STAI, ICF, State-Trait Anxiety Inventory, Individual Clinician Feedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hernia video | Active comparator | Other: Explanatory videoThe 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. |
| Mock video | Placebo comparator | Other: Explanatory videoThis 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. |
| Control group | Sham comparator | Other: Informed consent formThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- unilateral or bilateral hernia with indication for surgical therapy
- signed informed consent form for trial participation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Explanatory videoLinks to explanatory videos handed out to patients to be watched at home after standard informed consent giving | Other | Hernia video, Mock video |
| Informed consent formLinks to a digital version of the informed consent form already discussed during the process of informed consent giving. | Other | Control group |
Primary outcome
Score in multiple-choice-test
Time frame: assessed 1-2 days after group allocation/exposure
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".
3 secondary outcomes
Spielberg State-Trait Anxiety Inventory (STAI)
Time frame: assessed 1-2 days after group allocation/exposure
Individual Clinician Feedback (ICF)
Time frame: assessed 30 days postoperatively at follow-up visit
Numerical rating scale (NRS)
Time frame: assessed 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Derived from this study: PubMed 33500291Lunger 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Gingert, MD principal investigator
Cantonal Hospital Winterthur, Department of Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Explanatory video and Informed consent form in people with Inguinal Hernia, run by Kantonsspital Winterthur KSW at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabian Lunger, MD,PhD (+41 052 266 21 21, fabian.lunger@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score in multiple-choice-test (time frame: assessed 1-2 days after group allocation/exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04494087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.