title: Impact of preoperative patient education on prevention of postoperative complications after major visceral surgery: study protocol for a randomized controlled trial (PEDUCAT trial).
abstract: BACKGROUND
  In line with the growing number of surgical procedures being performed worldwide, postoperative complications are also increasing proportionately. Prevention of these postoperative complications is a high medical priority. Preoperative education of patients, including provision of preparatory information about the correct behavior after surgery, could improve the postoperative outcome, but the evidence for this is inconclusive. The aim of the PEDUCAT trial is to evaluate the feasibility and the impact of preoperative patient education on postoperative morbidity, mortality and quality of life in patients scheduled for elective major visceral surgery.
  
  
  METHODS
  PEDUCAT is designed as a cluster-randomized controlled pilot study. The experimental group will visit a standardized preoperative seminar to learn how best to behave after surgery in addition to being given a standard information brochure, whereas the control group will only receive the information brochure. Outcome measures such as postoperative morbidity, postoperative pain, postoperative anxiety and depression, patient satisfaction, quality of life, length of hospital stay and postoperative mortality will be evaluated. Statistical analysis will be based on the intention-to-treat population. Analysis of covariance will be applied for the intervention group comparison, adjusting for age, center and quality of life before surgery. This is a pilot study to show the feasibility of the concept. Nevertheless, the planned sample size of n = 204 is large enough to show an effect with power of 90% and a significance level of 5%.
  
  
  BACKGROUND
  German Clinical Trial Register number: DRKS00004226.
authors: The Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany.
authors: Christine
authors: C
authors: Fink
authors: Markus K
authors: MK
authors: Diener
authors: Thomas
authors: T
authors: Bruckner
authors: Gisela
authors: G
authors: Müller
authors: Lisa
authors: L
authors: Paulsen
authors: Monika
authors: M
authors: Keller
authors: Markus W
authors: MW
authors: Büchler
authors: Phillip
authors: P
authors: Knebel
mesh_terms: D002985:Clinical Protocols; D017558:Elective Surgical Procedures / Q000009:adverse effects* / Q000401:mortality; D005240:Feasibility Studies; D005858:Germany; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D057194:Intention to Treat Analysis; D007430:Intraoperative Care; D007902:Length of Stay; D010174:Pamphlets; D010353:Patient Education as Topic / Q000379:methods; D017060:Patient Satisfaction; D010865:Pilot Projects; D011183:Postoperative Complications / Q000401:mortality / Q000517:prevention & control* / Q000523:psychology; D011788:Quality of Life; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
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