Video-assisted vs conventional surgical informed consent in visceral surgery, a cluster-randomized clinical trial

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26680260

Enrollment

330

Registered

2025-10-30

Start date

2023-09-01

Completion date

Unknown

Last updated

2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Video-assisted versus conventional surgical informed consent before elective surgery Surgery

Interventions

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 durati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Sufficient proficiency in the German language 3. Elective indication for surgery

Exclusion criteria

Exclusion criteria: 1. Occurrence of postoperative complications classified as grade IV or V according to the Clavien-Dindo classification

Design outcomes

Primary

Measure	Time frame
Physician consultation time measured using a stopwatch at the consultation	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactSvenja Leicht

svenja.leicht@web.de+49 15164836496

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Sep 7, 2026