Impact of preoperative patient education on the prevention of postoperative complications after major visceral surgery: the cluster randomized controlled PEDUCAT trial

Abstract

BackgroundThe prevention of postoperative complications is of prime importance after complex elective abdominal operations. Preoperative patient education may prevent postoperative complications and improve patients’ wellbeing, but evidence for its efficacy is poor. The aims of the PEDUCAT trial were (a) to assess the impact of preoperative patient education on postoperative complications and patient-reported outcomes in patients scheduled for elective complex visceral surgery and (b) to evaluate the feasibility of cluster randomization in this setting.MethodsAdult patients (age ≥ 18 years) scheduled for elective major visceral surgery were randomly assigned in clusters to attend a preoperative education seminar or to the control group receiving the department’s standard care. Outcome measures were the postoperative complications pneumonia, deep vein thrombosis (DVT), pulmonary embolism, burst abdomen, and in-hospital fall, together with patient-reported outcomes (postoperative pain, anxiety and depression, patient satisfaction, quality of life), length of hospital stay (LOS), and postoperative mortality within 30 days after the index operation. Statistical analysis was primarily by intention to treat.ResultsIn total 244 patients (60 clusters) were finally included (intervention group 138 patients; control group 106 patients). Allocation of hospital wards instead of individual patients facilitated study conduct and reduced confusion about group assignment. In the intervention and control groups respectively, pneumonia occurred in 7.4% versus 8.3% (p = 0.807), pulmonary embolism in 1.6% versus 1.0% (p = 0.707), burst abdomen in 4.2% versus 1.0% (p = 0.165), and in-hospital falls in 0.0% versus 4.2% of patients (p = 0.024). DVT did not occur in any of the patients. Mortality rates (1.4% versus 1.9%, p = 0.790) and LOS (14.2 (+/− 12.0) days versus 16.1 (+/− 15.0) days, p = 0.285) were also similar in the intervention and control groups.ConclusionsCluster randomization was feasible in the setting of preoperative patient education and reduced the risk of contamination effects. The results of this trial indicate good postoperative outcomes in patients undergoing major visceral surgery without superiority of preoperative patient education compared to standard patient care at a high-volume center. However, preoperative patient education is a helpful instrument not only for teaching patients but also for training the nursing staff.Trial registrationGerman Clinical Trials Registry, DRKS00004226. Registered on 23 October 2012. Registered 8 days after the first enrollment.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2676-6) contains supplementary material, which is available to authorized users.

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“…A more recent RCT of 73 patients with colorectal cancer, reported improved body image after surgery and enhanced recovery of self-reported global health status and reduced LOS after extra preoperative group education [ 18 ]. However, meta-analyses on education for patients undergoing elective spinal surgery as well as a cluster RCT in patients undergoing visceral surgery did not report any sustained benefit on the majority of clinical outcome [ 19 , 20 ]. The educational intervention proves hard to standardize, and there is a paucity in research assessing its benefits for bariatric surgery.…”

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“…The clinician and researcher developed questionnaire has been in use since 2017 (Additional file 2 ) and consists of five core and three follow up questions. Participants completed three items on a five point likert scale (ranging from strongly disagree to strongly agree) aimed at assessing patient satisfaction and based on statements previously used to evaluate pre-operative education [ 33 ]. Additional questions provided further demographic data including highest level of education and history of smoking.…”

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“…A clinical trial in Taiwan also reported no effect of the treatment when the outcome was current level of pain and the average level of pain, instead of worst pain intensity [52]. It is also worthy to mention that a recent RCT from Germany, reported no superiority of preoperative patient education over the standard of care for most of the outcome measures authors used, including postoperative pain intensity [53]. Patients' participation in decision making was notably higher in the treatment group compared to the control at 24 hours after the surgery.…”