The impact of pre-operative patient education on post-operative outcome after major visceral surgery - A cluster-randomized controlled trial (PEDUCAT Trial)

The impact of pre-operative patient education on post-operative outcome after major visceral surgery - A cluster-randomized controlled trial (PEDUCAT Trial) - PEDUCAT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004226

Enrollment

204

Registered

2012-10-23

Start date

2012-10-15

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

post-operative morbidity (pulmonary, thrombotic, surgical, traumatic), mortality, post-operative pain, peri-operative anxiety/depression, quality of life and length of hospital stay

Interventions

Group 1: Patients are provided with a general information brochure and an hour long seminar with presentations of various health related exercises Group 2: Patients are provided with a general inform

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1.Feasibility 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) 2. Generation of hypotheses Furthermore, the aim of the explorative study is to investigate the impact of the pre-operative education program on - post-operative morbidity (pulmonary, thrombotic, surgical, traumatic) (on day 2+7+30 after surgery) -mortality (on day 2+7+30 after surgery) - post-operative pain (at baseline, day 2+7 after surgery; with modified Brief Pain Inventory) - peri-operative anxiety/depression (at baseline, day 7+30 after surgery; with Hospital Anxiety and Depression Scale) - 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.	—

Measure

Time frame

1.Feasibility 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) 2. Generation of hypotheses Furthermore, the aim of the explorative study is to investigate the impact of the pre-operative education program on - post-operative morbidity (pulmonary, thrombotic, surgical, traumatic) (on day 2+7+30 after surgery) -mortality (on day 2+7+30 after surgery) - post-operative pain (at baseline, day 2+7 after surgery; with modified Brief Pain Inventory) - peri-operative anxiety/depression (at baseline, day 7+30 after surgery; with Hospital Anxiety and Depression Scale) - 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.

—

Countries

Germany

Contacts

Public ContactUlla Klaiber

Abteilung für Allgemein-, Viszeral- und Transplantationschirurgie; Chirurgische Universitätsklinik Heidelberg

ulla.klaiber@med.uni-heidelberg.de06221-56-35984

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 22, 2026