Skip to content

Evaluating the Use of a Video-assisted Informed Consent Tool to Reduce Decision Conflict in Gastric Cancer Surgery: A Single-Center Open-Label Randomized Controlled Trial

Evaluating the Use of a Video-assisted Informed Consent Tool "MediOS" to Reduce Decision Conflict in Gastric Cancer Surgery: A Single-Center Open-Label Randomized Controlled Trial - Evaluating the Use of a Video-assisted Informed Consent Tool to Reduce Decision Conflict in Gastric Cancer Surgery: A Single-Center Open-Label Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056846
Enrollment
60
Registered
2025-01-28
Start date
2022-07-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Gastric Cancer

Interventions

Pre-Consultation Video (PreVid) Group: Patients viewed the video before the face-to-face consultation with the surgeon. Post-Consultation Video Group (PostVid) Group: Patients viewed the video after t
s consultation.

Sponsors

Fujita Health University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who have provided written informed consent based on sufficient explanation, thorough understanding, and their own free will. Patients aged 20 years or older but under 75 years at the time of consent. Patients diagnosed with clinically resectable gastric cancer at stage I-III. Patients scheduled for informed consent for elective surgery Patients for whom the principal investigator or sub-investigators confirm that the attending physician can clearly present the treatment plan during the initial consultation based on prior diagnostic results.

Exclusion criteria

Exclusion criteria: Patients with a history of gastric cancer surgery (e.g., remnant gastric cancer patients). Patients classified as Grade 3 or higher by the American Society of Anesthesiologists (ASA). Patients are scheduled for neoadjuvant chemotherapy (NAC). Patients with comorbid psychiatric disorders, psychological symptoms, or cognitive impairment, were deemed unable to participate in the study. Patients or accompanying family members unable to operate the MediOS system. Any other patients deemed unsuitable by the principal investigator or sub-investigators.

Design outcomes

Primary

MeasureTime frame
Decisional Conflict Scale Score

Secondary

MeasureTime frame
Change in Informed Consent Time Change in Total Time Required for Outpatient Consultations Surgery-related Parameters: Operative Time, Blood Loss, Postoperative Complications Exploratory Evaluation Items

Countries

Japan

Contacts

Public ContactSusumu Shibasaki

Fujita Health University Department of Surgery

susumu.shibasaki@fujita-hu.ac.jp0562-93-9254

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026