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Patient empowerment in gastrointestinal oncological surgery – a randomized controlled trial on the use of digital perioperative information materials for patient education

Patient empowerment in gastrointestinal oncological surgery – a randomized controlled trial on the use of digital perioperative information materials for patient education - PRIMETIME

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034904
Enrollment
232
Registered
2024-08-28
Start date
2024-10-20
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

C15 C16 C18 C19 C20 C22 C23 C24 C25

Interventions

Group 1: Additional digital information material (After randomization, patients in Arm 1 will receive access to additional digital information material, which will be made available via Microsoft Sway

Sponsors

Universitätsklinikum Ulm, Klinik für Allgemein- und Viszeralchirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing visceral surgery with curative intent due to a primary or secondary malignancy, Tumor board decision available, Verbal and written informed consent

Exclusion criteria

Exclusion criteria: Pregnancy, ASA = 4, Mental impairment that prevents understanding of the nature, type and scope of the research project, Expected lack of awareness of the recommendations, Lack of capacity to consent, Participation in another study that affects the study outcome

Design outcomes

Primary

MeasureTime frame
Satisfaction with information 90 ± 7 days after surgery

Secondary

MeasureTime frame
Average level of information, quality of life, treatment satisfaction, overall survival, type and extent of surgery, duration of surgery, total blood loss, time to functional recovery, postoperative hospital stay, postoperative length of stay in IMC/intensive care unit, readmission rate, readmission rate in IMC/intensive care unit, need for invasive procedures postoperatively, postoperative medical complications, postoperative surgical complications, perioperative morbidity, pathological features, planned subsequent oncological therapy, oncological therapy performed and response to therapy, evaluation of the intervention

Countries

Germany

Contacts

Public ContactElisabeth Miller

Klinik für Allgemein- und Viszeralchirurgie

elisabeth.miller@uniklinik-ulm.de+49 731 5000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026