The impact of pre-operative patient education on post-operative outcome after major visceral surgery - A cluster-randomized controlled trial (PEDUCAT Trial)
Organizational Data
- DRKS-ID:
- DRKS00004226
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2012-10-23
- Last update in DRKS:
- 2016-11-24
- Registration type:
- Retrospective
Acronym/abbreviation of the study
PEDUCAT
URL of the study
No Entry
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.
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
Health condition or problem studied
- Free text:
- post-operative morbidity (pulmonary, thrombotic, surgical, traumatic), mortality, post-operative pain, peri-operative anxiety/depression, quality of life and length of hospital stay
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Patients are provided with a general information brochure and an hour long seminar with presentations of various health related exercises
- Arm 2:
- Patients are provided with a general information brochure without additional education
Endpoints
- 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.
- Secondary outcome:
- No Entry
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Viszeralchirurgie Heidelberg
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2012-10-15
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2014-03-08
- Target Sample Size:
- 204
- Final Sample Size:
- 220
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- 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
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
Addresses
Primary Sponsor
- Address:
- Abteilung für Allgemein,- Viszeral,- und Transplantationschirurgie, Chirurgische Universitätsklinik HeidelbergDr. med. Phillip KnebelIm Neuenheimer Feld 11069120 HeidelbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Abteilung für Allgemein-, Viszeral- und Transplantationschirurgie; Chirurgische Universitätsklinik HeidelbergDr. med. Ulla KlaiberIm Neuenheimer Feld 11069120 HeidelbergGermany
- Telephone:
- 06221-56-35984
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Abteilung für Allgemein-, Viszeral- und Transplantationschirurgie; Chirurgische Universitätsklinik HeidelbergDr. med. Ulla KlaiberIm Neuenheimer Feld 11069120 HeidelbergGermany
- Telephone:
- 06221-56-35984
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Abteilung für Allgemein-, Viszeral- und Transplantationschirurgie; Chirurgische Universitätsklinik HeidelbergDr. med. Ulla KlaiberIm Neuenheimer Feld 11069120 HeidelbergGermany
- Telephone:
- 06221-56-35984
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- B. Braun StiftungStadtwaldpark 1034212 MelsungenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät HeidelbergAlte Glockengießerei 11/169115 HeidelbergGermany
- Telephone:
- +49-6221-338220
- Fax:
- +49-6221-3382222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2012-07-15
- Ethics committee number:
- S-376/2012
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2012-10-02
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry