ESCP Safe Anastomosis ProGramme in CoLorectal SurgEry (EAGLE):Study protocol for an international cluster randomised trial of a quality improvement intervention to reduce anastomotic leak following right colectomy

AIM: Cohort data suggest that anastomotic leak occurs after 8% of right colectomies causing significant morbidity and mortality. Patient selection, intra-operative factors, and technical variation all contribute to risk of leak. The EAGLE study will assess whether implementation of the European Society of Coloproctology (ESCP) Safe Anastomosis Intervention reduces anastomotic leak following right colectomy.METHODS: An international, multi-centre, cluster randomised trial will be undertaken with hospitals as clusters. Hospitals will be recruited in a number of distinct phases, with each phase following the same research plan, in which clusters are randomised to one of three, staggered (dog-leg) schedules for implementation of the Safe Anastomosis Intervention.RESULTS: Results from different phases will be meta-analysed. The intervention is a three-component behavioural change programme for surgeons, anaesthetists and operating room staff, supported by an online learning environment. All colorectal surgical units around the world will be eligible. Adults undergoing elective or emergency right colectomy or ileocaecal resection, by any approach and for any indication will be included. The primary outcome is 30-day anastomotic leak rate, defined as clinical or radiologically-detected leak or intra-abdominal or pelvic collection. Assuming hospitals provide data for an average of 10 patients per two month recruitment period, 333 clusters (4440 patients in total) will allow for detection of an absolute risk reduction of anastomotic leak from 8.1% to 5.6% (relative risk reduction 30%). This protocol adheres to Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT).DISCUSSION: The protocol describes the methods for an evaluation of a hospital-level, education-based quality improvement intervention targeted to reduce the life-threatening surgical complication of anastomotic leak.</p

The cost-effectiveness of wound-edge protection devices compared to standard care in reducing surgical site infection after laparotomy: an economic evaluation alongside the ROSSINI trial.

BACKGROUND: Wound-edge protection devices (WEPDs) have been used in surgery for more than 40 years to reduce surgical site infection (SSI). No economic evaluation of WEPDs against any comparator has ever been conducted. The aim of the paper was to assess whether WEPDs are cost-effective in reducing SSI compared to standard care alone in the United Kingdom. METHODS AND FINDINGS: An economic evaluation was conducted alongside the ROSSINI trial. The study perspective was that of the UK National Health Service and the time horizon was 30 days post-operatively. The study was conducted in 21 UK hospitals. 760 patients undergoing laparotomy were randomised to either WEPD or standard care and 735 were included in the primary analysis. The main economic outcome was cost-effectiveness based on incremental cost (£) per quality adjusted life year (QALY) gained. Patients in the WEPD arm accessed health care worth £5,420 on average and gained 0.02131 QALYs, compared to £5,130 and 0.02133 QALYs gained in the standard care arm. The WEPD strategy was more costly and equally effective compared to standard care, but there was significant uncertainty around incremental costs and QALYs. The findings were robust to a range of sensitivity analyses. CONCLUSIONS: There is no evidence to suggest that WEPDs can be considered a cost effective device to reduce SSI. Their continued use is a waste of limited health care resources

Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial).

OBJECTIVE: To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery. DESIGN: Multicentre observer blinded randomised controlled trial. PARTICIPANTS: Patients undergoing laparotomy at 21 UK hospitals. INTERVENTIONS: Standard care or the use of a wound edge protection device during surgery. MAIN OUTCOME MEASURES: Surgical site infection within 30 days of surgery, assessed by blinded clinicians at seven and 30 days and by patient's self report for the intervening period. Secondary outcomes included quality of life, duration of stay in hospital, and the effect of characteristics of the patient and operation on the efficacy of the device. RESULTS: 760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group. Six patients in the device group and five in the control group did not undergo laparotomy. Fourteen patients, seven in each group, were lost to follow-up. A total of 184 patients experienced surgical site infection within 30 days of surgery, 91/369 (24.7%) in the device group and 93/366 (25.4%) in the control group (odds ratio 0.97, 95% confidence interval 0.69 to 1.36; P=0.85). This lack of benefit was consistent across wound assessments performed by clinicians and those reported by patients and across all secondary outcomes. In the secondary analyses no subgroup could be identified in which there was evidence of clinical benefit associated with use of the device. CONCLUSIONS: Wound edge protection devices do not reduce the rate of surgical site infection in patients undergoing laparotomy, and therefore their routine use for this role cannot be recommended. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 40402832

Surgical site infection and costs in low- and middle-income countries:a systematic review of the economic burden

Background: Surgical site infection (SSI) is a worldwide problem which has morbidity, mortality and financial consequences. The incidence rate of SSI is high in Low- and Middle-Income countries (LMICs) compared to high income countries, and the costly surgical complication can raise the potential risk of financial catastrophe. Objective: The aim of the study is to critically appraise studies on the cost of SSI in a range of LMIC studies and compare these estimates with a reference standard of high income European studies who have explored similar SSI costs.Methods A systematic review was undertaken using searches of two electronic databases, EMBASE and MEDLINE In-Process &amp; Other Non-Indexed Citations, up to February 2019. Study characteristics, comparator group, methods and results were extracted by using a standard template. Results: Studies from 15 LMIC and 16 European countries were identified and reviewed in full. The additional cost of SSI range (presented in 2017 international dollars) was similar in the LMIC ($174 -$29,610) and European countries ($21 -$34,000). Huge study design heterogeneity was encountered across the two settings. Discussion: SSIs were revealed to have a significant cost burden in both LMICs and High Income Countries in Europe. The magnitude of the costs depends on the SSI definition used, severity of SSI, patient population, choice of comparator, hospital setting, and cost items included. Differences in study design affected the comparability across studies. There is need for multicentre studies with standardized data collection methods to capture relevant costs and consequences of the infection across income settings. Other: Funding: National Institute of Health Research (NIHR) Global Health Research Unit Grant (NIHR 17-0799). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR, or the UK Department of Health and Social Care.<br/