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. 2021 Apr 21;22(1):297.
doi: 10.1186/s13063-021-05202-y.

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

S W de Jonge #  1 , N Wolfhagen #  1 , A H Zwinderman  2 , M W Hollmann  3 , M A Boermeester  1 , M G W Dijkgraaf  4 ; EPO2CH study group
Collaborators, Affiliations

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

S W de Jonge et al. Trials. .

Abstract

Background: Surgical site infections (SSI) are frequent complications after elective abdominal surgery. We designed the Enhanced PeriOperative Care and Health Protection programme (EPO2CH) care bundle, comprising of intraoperative high fractional inspired oxygen; intraoperative goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; glucose control and treatment of hyperglycaemia (> 10 mmol L- 1) in diabetics as well as non-diabetics; and wound irrigation before closure using an aqueous antiseptic. We hypothesise that EPO2CH added to standard care reduces the incidence of SSI compared to standard care alone for elective abdominal surgery.

Methods: This trial is designed as an open label, pragmatic randomised controlled parallel-group multicentre superiority trial. The primary endpoint is the incidence of SSI, defined by the Centers for Disease Control and prevention, within 30 days after surgery. The incidence of SSI is assessed using the Dutch national complication register and medical chart review. Secondary endpoints include the SSI incidence within 90 days, incidence of anastomotic leakage at 30 and 90 days, the incidence of incisional hernia within 1 year, mortality within 1 year and 5 years, quality of life, health and disability, and cost-effectiveness. Primarily, an intention-to-treat analysis will be performed to estimate the relative risk using a log binomial model. If not feasible, a logistic regression will be used to estimate the odds ratio. A per-protocol analysis will also be performed. Furthermore, the attributive effect of the distinct interventions will be explored.

Discussion: The results of the EPO2CH trial will determine if the EPO2CH bundle is effective to prevent SSI incidence for patients undergoing elective abdominal surgery. Details of the statistical analysis are described in this Statistical Analysis Plan (SAP).

Trial registration: Registration number: Dutch Trial Register Trial NL5572 . Registered on March 3, 2016. SAP version: V1.0, January 8, 2020. This SAP has been written based on study protocol V10.

Keywords: Anaesthesia; Cost-effectiveness; Prevention; Surgery; Surgical site infection.

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Conflict of interest statement

Prof. Boermeester reported receiving institutional grants from J&J/Ethicon, KCI/3M, Bard and New Compliance; and being an advisory board member and/or speaker and/or instructor for KCI/3M, J&J/Ethicon, Allergan, Bard, Gore, Smith & Nephew. No other disclosures were reported.

Figures

Fig. 1
Fig. 1
“CONSORT Flow diagram EPO2CH Trial”
See this image and copyright information in PMC

References

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