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

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.

Enhanced PeriOperative Care and Health protection programme for the prevention of surgical site infections after elective abdominal surgery (EPO2CH): statistical analysis plan of a randomised controlled multicentre superiority trial

“…A total of 3000 patients, 1500 to be assigned to each group, was required according to the sample size calculation. Further details regarding the sample size calculation are published in the study protocol [ 7 ]. The Data Safety Monitoring Board (DSMB) will perform a sample size recalculation after follow-up of 1500 patients to determine the definite sample size.…”

“…Other (long-term) secondary outcomes include SSI incidence within 30 days assessed through a post-discharge self-assessment questionnaire (a Dutch translation of the Bluebelle Wound Healing questionnaire), SSI incidence within 30 days by self-reported wound photos, the incidence of incisional hernia within 1 year, and all-cause mortality within 1 year and 5 years [ 14 ]. Further details regarding outcomes and method of data collection are described in the study protocol [ 7 ].…”

“…In a sub-study of 48 patients, we will study perioperative subcutaneous oxygen pressure (PtO 2 ) (mmHg), mitochondrial PtO 2 (mmHg) and perioperative immune response. Further details regarding this sub-study are described in the study protocol [ 7 ].…”

“…Adult patients, scheduled for elective abdominal surgery involving an abdominal incision larger than 5 cm (open surgery as well as laparoscopic surgery with incisions larger than 5 cm (hand-assisted and/or for the excision specimen)), are eligible. Exclusion criteria are described in the study protocol [ 7 ]. Number of patients screened, ineligible, eligible and recruited, and eligible and not recruited are provided with the corresponding reasons.…”

“…The Amsterdam UMC Medical Ethics Committee (MEC) approved the study protocol. A trial protocol has been published [ 7 ]. Here we report the Statistical Analysis Plan (SAP) according to recently published guidelines [ 8 ].…”