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.

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.

Prophylactic use of alpha-1 adrenergic blocking agents for prevention of postoperative urinary retention: A review & meta-analysis of randomized clinical trials.

BACKGROUND: Alpha-1 adrenergic blockers used to treat postoperative urinary retention (POUR) may also have a preventative role. Here we assess the evidence behind their prophylactic use on POUR prevention. STUDY DESIGN: PRISMA guidelines were followed. All studies reviewed for eligibility, data extraction, and risk of bias assessment. Pooled risk ratios with 95% confidence intervals calculated using a random effects model. Heterogeneity assessed using Forest plots, I2 statistic and Chi-squared Cochran's Q-statistic. RESULTS: Fifteen RCTs (1732 patients) included. Prophylactic alpha-1 adrenergic blockers significantly reduced risk of POUR, 13.16% vs 30.24%, RR = 0.48 (95%CI: 0.33; 0.70, p-value = .001), without a statistically significant increase in adverse events. Substantial heterogeneity found between included studies (I2 = 65.49% [95%CI:48.49; 95.01] & Q-statistic 43.46 (p-value<.001)). Subgroup analysis revealed strong risk reduction and little heterogeneity in males (RR:0.33, 95%CI:0.23; 0.47, p-value<.001, I2:10.58) and patients receiving spinal anesthesia (RR:0.26, 95%CI:0.14; 0.46, p-value<.0001, I2 = 0%). CONCLUSION: Prophylactic alpha-1 adrenergic blockers reduce risk of POUR in males and after spinal anesthesia.

Meta-analysis and trial sequential analysis of triclosan-coated sutures for the prevention of surgical-site infection.

BACKGROUND: Triclosan-coated sutures (TCS) were developed to reduce the risk of surgical-site infection (SSI). Level 1A evidence of effectiveness has been presented in various recent meta-analyses, yet well designed RCTs have not been able to reproduce these favourable results. The aim of this study was to evaluate all available evidence critically with comprehensive analysis to seek a more reliable answer regarding the effectiveness of TCS in the prevention of SSI. METHODS: PubMed, MEDLINE, Embase and Cochrane Library databases were searched from 1990 to November 2015 for RCTs that compared TCS with sutures that were exactly the same, but uncoated, in the prevention of SSI. Pooled relative risks (RRs) with corresponding 95 per cent confidence intervals were estimated using a random-effects model. Metaregression was used to substantiate subgroup effects, trial sequential analysis was employed to assess the risk of random error, and quality of evidence was determined using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. RESULTS: Twenty-one RCTs including 6462 patients were included. Risk of bias was serious. Pooled effects showed a RR of 0·72 (95 per cent c.i. 0·60 to 0·86; P < 0·001) for all publications. At a risk of 138 SSIs per 1000 procedures, the use of TCS reduced this by 39 (95 per cent c.i. 19, 55). Trial sequential analysis confirmed a RR reduction of 15 per cent for the use of TCS. CONCLUSION: GRADE assessment shows moderate-quality evidence that TCS are effective in reducing SSI. Trial sequential analysis indicates that the effect was robust, and additional data are unlikely to alter the summary effect.