The impact of pre-operative patient education on post-operative outcome after major visceral surgery - A cluster-randomized controlled trial (PEDUCAT Trial)
Not Applicable
- Conditions
- post-operative morbidity (pulmonary, thrombotic, surgical, traumatic), mortality, post-operative pain, peri-operative anxiety/depression, quality of life and length of hospital stay
- Registration Number
- DRKS00004226
- Lead Sponsor
- Abteilung für Allgemein,- Viszeral,- und Transplantationschirurgie, Chirurgische Universitätsklinik Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
•Age equal or greater than 18 years
•Patients scheduled for elective major visceral surgery (=180 min planned procedure time)
•Written informed consent
Exclusion Criteria
•Impaired mental state
•Insufficient knowledge of the German language
•Patients who cannot participate due to physical constraints or infections requiring isolation
•Patients who already took part in the pre-operative education program in Heidelberg
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Feasibility<br>The aim of the study is to analyze the feasibility of the planned sequel study (e.g. feasibility of cluster-randomization and recruitment of patients)<br>2. Generation of hypotheses<br>Furthermore, the aim of the explorative study is to investigate the impact of the pre-operative education program on <br>- post-operative morbidity (pulmonary, thrombotic, surgical, traumatic) (on day 2+7+30 after surgery)<br>-mortality (on day 2+7+30 after surgery)<br>- post-operative pain (at baseline, day 2+7 after surgery; with modified Brief Pain Inventory) <br>- peri-operative anxiety/depression (at baseline, day 7+30 after surgery; with Hospital Anxiety and Depression Scale)<br>- quality of life (at baseline, and day 30 after surgery; with SF-12) and length of hospital stay for 204 patients to detect suitable endpoints.<br>
- Secondary Outcome Measures
Name Time Method