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

• DOI: 10.1186/s13063-021-05202-y
• Publication Date: 2021-04-21T10:11:12Z
• Authors: S. W. de Jonge; N. Wolfhagen; A. H. Zwinderman; M. W. Hollmann; M. A. Boermeester; M. G. W. Dijkgraaf
• Keywords: Clinical endpoint; Incisional Hernia; Elective surgery

Abstract Background Surgical site infections (SSI) are frequent complications after elective abdominal surgery. We designed the Enhanced PeriOperative Care and Health Protection programme (EPO 2 CH) care bundle, comprising of intraoperative high fractional inspired oxygen; goal-directed fluid therapy; active preoperative, postoperative warming; glucose control treatment hyperglycaemia (> 10 mmol L − 1 ) in diabetics as well non-diabetics; wound irrigation before closure using an aqueous antiseptic. hypothesise that EPO CH added to standard reduces incidence SSI compared alone for Methods This trial is open label, pragmatic randomised controlled parallel-group multicentre superiority trial. The primary endpoint SSI, defined by Centers Disease Control prevention, within 30 days assessed Dutch national complication register medical chart review. Secondary endpoints include 90 days, anastomotic leakage at incisional hernia year, mortality year 5 years, quality life, health disability, cost-effectiveness. Primarily, intention-to-treat analysis will be performed estimate relative risk a log binomial model. If not feasible, logistic regression used odds ratio. A per-protocol also performed. Furthermore, attributive effect distinct interventions explored. Discussion results determine if bundle effective prevent patients undergoing Details statistical described this Statistical Analysis Plan (SAP). Trial registration Registration number: Register NL5572 . Registered on March 3, 2016. SAP version: V1.0, January 8, 2020. has been written based study protocol V10.