1. Enhanced PeriOperative Care and Health protection programme for the prevention of surgical site infections after elective abdominal surgery (EPOCH): Study protocol of a randomised controlled, multicentre, superiority trial
- Author
-
Seppe Jsha Koopman, Joost A B van der Hoeven, Ahmet Demirkiran, Linda M. Posthuma, Marja A. Boermeester, Thomas Slotema, Linda M Over, Peter van Duijvendijk, W J Bom, Jens Peter Hering, Eduard R Hendriks, Quirine J J Boldingh, Ewoud B Kluyver, Markus W. Hollmann, Dirk Ja Sonneveld, Charles C. van Rossem, Luc R.C.W. van Lonkhuijzen, Stijn W. de Jonge, Bart Mf van der Leeuw, Otto E van Geffen, Werner A. Draaisma, J C G Scheijmans, Niels Wolfhagen, Marcel G. W. Dijkgraaf, Graduate School, Surgery, ACS - Heart failure & arrhythmias, AGEM - Digestive immunity, AII - Infectious diseases, Amsterdam Gastroenterology Endocrinology Metabolism, Anesthesiology, ACS - Diabetes & metabolism, APH - Quality of Care, Epidemiology and Data Science, APH - Methodology, and ACS - Microcirculation
- Subjects
medicine.medical_specialty ,Incisional hernia ,Cost effectiveness ,lcsh:Medicine ,preventive medicine ,Perioperative Care ,Superiority Trial ,Abdomen ,medicine ,Clinical endpoint ,Humans ,Multicenter Studies as Topic ,Surgical Wound Infection ,EPOCH (chemotherapy) ,adult surgery ,adult anaesthesia ,wound management ,Netherlands ,Randomized Controlled Trials as Topic ,business.industry ,lcsh:R ,Postoperative complication ,General Medicine ,Perioperative ,medicine.disease ,Elective Surgical Procedures ,Emergency medicine ,Surgery ,business ,Abdominal surgery - Abstract
IntroductionSurgical site infections (SSI) are a common postoperative complication. During the development of the new WHO guidelines on SSI prevention, also in the Netherlands was concluded that perioperative care could be optimised beyond the current standard practice. We selected a limited set of readily available, cheap and evidence-based interventions from these new guidelines that are not part of standard practice in the Netherlands and formulated an Enhanced PeriOperative Care and Health bundle (EPOCH). Here, we describe the protocol for an open-label, randomised controlled, parallel-group, superiority trial to test the effect of the EPOCH bundle added to (national) standard care in comparison to standard care alone on the incidence of SSI.Methods and analysisEPOCH consists of intraoperative high fractional inspired oxygen (0.80); goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; perioperative glucose control and treatment of severe hyperglycaemia (>10 mmoll-1) and standardised surgical site handling. Patients scheduled for elective abdominal surgery with an incision larger than 5 cm are eligible for inclusion. Participants are randomised daily, 1:1 according to variable block sizes, and stratified per participating centre to either EPOCH added to standard care or standard care only. The primary endpoint will be SSI incidence according to the Centers for Disease Control and Prevention (CDC) definition within 30 days as part of routine clinical follow-up. Four additional questionnaires will be sent out over the course of 90 days to capture disability and costs. Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness. Analysis of the primary endpoint will be on an intention-to-treat basis.Ethics and disseminationEthics approval is granted by the Amsterdam UMC Medical Ethics Committee (reference 2015_121). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results.Trial registration numberRegistered in the Dutch Trial Register: NL5572.
- Published
- 2020