Impact of preoperative patient education on prevention of postoperative complications after major visceral surgery: study protocol for a randomized controlled trial (PEDUCAT trial)

Trials

Phillip Knebel¹  Markus W Büchler¹  Monika Keller³  Lisa Paulsen¹  Gisela Müller¹  Thomas Bruckner²  Markus K Diener¹  Christine Fink¹ 

[1] Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany;Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany;Psychosocial Care Unit, Department of Surgery, University Hospital, Heidelberg, Germany

关键词: Cluster randomization;    Visceral surgery;    Prevention;    Postoperative complication;    Preoperative education;    Patient education;   

Others  :  1093166
DOI  :  10.1186/1745-6215-14-271

 received in 2013-06-14, accepted in 2013-08-20,  发布年份 2013

【 摘 要 】

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/design

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%.

Trial registration

German Clinical Trial Register number: DRKS00004226.

【 授权许可】

   
2013 Fink et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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