Video-assisted vs conventional surgical informed consent in visceral surgery, a cluster-randomized clinical trial
| ISRCTN | ISRCTN26680260 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26680260 |
- Submission date
- 28/10/2025
- Registration date
- 30/10/2025
- Last edited
- 30/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This study looks at two different ways of giving patients information before surgery: the traditional face-to-face talk with a doctor, and a video explanation. The goal is to see if using a video can save doctors time while still helping patients understand their surgery and feel satisfied with the information they receive.
Who can participate?
Patients who are having either their gallbladder removed or part of their colon removed at the University Hospital of Würzburg can take part in the study.
What does the study involve?
Participants are randomly placed into one of two groups. One group watches a video that explains the surgery, while the other group receives the usual in-person explanation from a doctor. Afterward, both patients and doctors fill out short questionnaires about how well the information was understood and how satisfied they were. The time spent on each method is also recorded.
What are the possible benefits and risks of participating?
The study may help improve how patients are informed before surgery in the future. There are no known risks from taking part, and all participants still receive the necessary information about their surgery, either by video or in person.
Where is the study run from?
University Hospital of Würzburg in Germany
When is the study starting and how long is it expected to run for?
The study began in September 2023 and is expected to finish in March 2025.
Who is funding the study?
University Hospital of Würzburg in Germany
The educational video used in the study was developed by medudoc education GmbH.
Who is the main contact?
Dr Svenja Leicht, svenja.leicht@web.de
Contact information
Public, Scientific, Principal investigator
Dr.-Georg-Fuchs-Straße 12
Würzburg
97074
Germany
 ORCID ID |
0009-0008-2156-8435 |
|---|---|
| Phone | +49 15164836496 |
| svenja.leicht@web.de |
Study information
| Study design | Single center interventional cluster-randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 48300Patient information sheet.pdf |
| Scientific title | Video-assisted surgical informed consent, compared to conventional informed consent, reduces physicians’ time expenditure while maintaining patient satisfaction and understanding. A cluster-randomized clinical trial |
| Study objectives | The objective of this study was to compare video-assisted with conventional surgical informed consent in terms of duration, patient understanding, as well as patient and physician satisfaction. |
| Ethics approval(s) |
Approved 20/01/2023, Ethics Committee of the Julius-Maximilians-University of Würzburg (Petrinistraße 33a, Würzburg, 97080, Germany; +49 931 31 48315; ethikkommission@uni-wuerzburg.de), ref: 112/22 |
| Health condition(s) or problem(s) studied | Video-assisted versus conventional surgical informed consent before elective surgery |
| Intervention | Patients in the intervention group receive a video developed by medudoc education GmbH, while the control group receives physician-led informed consent according to the hospital's standard. The duration of both methods is measured using a stopwatch. Patients in both groups complete questionnaires on satisfaction and understanding after the surgical informed consent and postoperatively. Upon study completion, participating physicians also complete a questionnaire to assess their satisfaction. Randomisation was conducted manually by the study management team to achieve approximately equal numbers in the intervention and control groups. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Physician consultation time measured using a stopwatch at the consultation |
| Secondary outcome measures | Measured at the consultation: 1. Depressivity: PHQ-2 2. General anxiety: GAD-2 3. Surgery-related anxiety: APAIS 4. Illness and treatment beliefs: IPQ-R 5. Patient satisfaction: ZUF-8 6. Patient understanding: self-developed questionnaire 7. Physician satisfaction: self-developed questionnaire 8. Additionally, data on diagnosis, type of surgery, and postoperative pain (assessed via the Numeric Rating Scale, NRS) were extracted from patient records |
| Overall study start date | 20/01/2023 |
| Completion date | 30/03/2025 |
Eligibility
| Participant type(s) | Health professional, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 330 |
| Total final enrolment | 153 |
| Key inclusion criteria | 1. Age ≥18 years 2. Sufficient proficiency in the German language 3. Elective indication for surgery |
| Key exclusion criteria | 1. Occurrence of postoperative complications classified as grade IV or V according to the Clavien-Dindo classification |
| Date of first enrolment | 01/09/2023 |
| Date of final enrolment | 30/03/2025 |
Locations
Countries of recruitment
- Germany
Study participating centre
Würzburg
97080
Germany
Sponsor information
Industry
Münzstraße 12
Berlin
10178
Germany
| Phone | +49 15678887332 |
|---|---|
| info@medudoc.com | |
| Website | https://www.de.medudoc.com/ |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 03/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated an analysed during the current study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in German | 30/10/2025 | No | Yes |
Additional files
- 48300Patient information sheet.pdf
- in German
Editorial Notes
29/10/2025: Trial's existence confirmed by Julius-Maximilians-University of Würzburg
