Abstract
BackgroundIn 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/designPEDUCAT 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 registrationGerman Clinical Trial Register number: DRKS00004226.
Highlights
In line with the growing number of surgical procedures being performed worldwide, postoperative complications are increasing proportionately
The aim of the PEDUCAT trial is to evaluate the feasibility and to investigate the impact of preoperative patient education on postoperative morbidity, mortality and quality of life in patients scheduled for elective major visceral surgical procedures
After Janis had opened up this field of research, numerous studies were conducted to investigate the impact of preoperative education
Summary
Rationale Despite the many advances in medicine, the need for surgical procedures remains high. PEDUCAT trial is to evaluate the feasibility and to investigate the impact of preoperative patient education on postoperative morbidity, mortality and quality of life in patients scheduled for elective major visceral surgical procedures. As distinguished from the studies performed until now the PEDUCAT trial is focusing on prevention of postoperative complications after major visceral surgery, for instance multivisceral resection, pancreaticoduodenectomy, esophagectomy, or rectal resection. After these major interventions a higher incidence of postoperative complications is expected and subsequently the impact of a preoperative patient education could be more evident
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