Trial document




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  DRKS00004226

Trial Description

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Title

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

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Trial Acronym

PEDUCAT

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URL of the Trial

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Brief Summary in Lay Language

Due to contradictory data, it remains unclear, to what extent presurgical patient education can progress patient satisfaction and reduce e.g. morbidity and mortality.

The PEDUCAT Trial is evaluating the impact of pre-operative patient education on post-operative outcome after major visceral surgery.

Therefore, two groups will be compared: Experimental intervention: Patients are provided with a general information brochure and an hour long seminar with presentations of various health related exercises
Control intervention: Patients are provided with a general information brochure without additional education


Patients scheduled for elective major visceral surgical procedure at the Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany can participate.

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Brief Summary in Scientific Language

The aim of this pragmatic, explorative and cluster-randomized pilot study is to analyze the feasibility of a sequel study (e.g. feasibility of cluster-randomization and patients recruitment). Furthermore, the aim of the explorative study is to investigate the impact of the pre-operative education program and to detect suitable endpoints, such as: post-operative morbidity (pulmonary, thrombotic, surgical, traumatic), mortality, post-operative pain, peri-operative anxiety and depression, quality of life and length of hospital stay for 204 patients. Therefore, two groups will be compared: Experimental intervention: Patients are provided with a general information brochure and an hour long seminar with presentations of various health related exercises.
Control intervention: Patients are provided with a general information brochure without additional education

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Organizational Data

  •   DRKS00004226
  •   2012/10/23
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  •   yes
  •   Approved
  •   S-376/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1132-4795 
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Health Condition or Problem studied

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

  •   Patients are provided with a general information brochure and an hour long seminar with presentations of various health related exercises
  •   Patients are provided with a general information brochure without additional education
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/10/15
  •   204
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

•Age equal or greater than 18 years
•Patients scheduled for elective major visceral surgery (≥180 min planned procedure time)
•Written informed consent

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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

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Addresses

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    • Abteilung für Allgemein,- Viszeral,- und Transplantationschirurgie, Chirurgische Universitätsklinik Heidelberg
    • Mr.  Dr. med.  Phillip  Knebel 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Abteilung für Allgemein-, Viszeral- und Transplantationschirurgie; Chirurgische Universitätsklinik Heidelberg
    • Ms.  Dr. med.  Ulla  Klaiber 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Abteilung für Allgemein-, Viszeral- und Transplantationschirurgie; Chirurgische Universitätsklinik Heidelberg
    • Ms.  Dr. med.  Ulla  Klaiber 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • B. Braun Stiftung
    • Stadtwaldpark 10
    • 34212  Melsungen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/03/08
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Trial Publications, Results and other Documents

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