Implementation of an enhanced recovery after surgery protocol for colorectal cancer in a regional hospital network supported by audit and feedback: a stepped wedge, cluster randomised trial.

BACKGROUND: Enhanced recovery after surgery (ERAS) protocols are known to potentially improve the management and outcomes of patients undergoing colorectal surgery, with limited evidence of their implementation in hospital networks and in a large population. We aimed to assess the impact of the implementation of an ERAS protocol in colorectal cancer surgery in the entire region of Piemonte, Italy, supported by an audit and feedback (A&F) intervention. METHODS: A large, stepped wedge, cluster randomised trial enrolled patients scheduled for elective surgery at 29 general surgery units (clusters). At baseline (first 3 months), standard care was continued in all units. Thereafter, four groups of clusters began to adopt the ERAS protocol successively. By the end of the study, each cluster had a period in which standard care was maintained (control) and a period in which the protocol was applied (experimental). ERAS implementation was supported by initial training and A&F initiatives. The primary endpoint was length of stay (LOS) without outliers (>94th percentile), and the secondary endpoints were outliers for LOS, postoperative medical and surgical complications, quality of recovery and compliance with ERAS items. RESULTS: Of 2626 randomised patients, 2397 were included in the LOS analysis (1060 in the control period and 1337 in the experimental period). The mean LOS without outliers was 8.5 days during the control period (SD 3.9) and 7.5 (SD 3.5) during the experimental one. The adjusted difference between the two periods was a reduction of -0.58 days (95% CI -1.07, -0.09; p=0.021). The compliance with ERAS items increased from 52.4% to 67.3% (estimated absolute difference +13%; 95% CI 11.4%, 14.7%). No difference in the occurrence of complications was evidenced (OR 1.22; 95% CI 0.89, 1.68). CONCLUSION: Implementation of the ERAS protocol for colorectal cancer, supported by A&F approach, led to a substantial improvement in compliance and a reduction in LOS, without meaningful effects on complications. Trial registration number NCT04037787.

Implementation of the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the Piemonte Region with an Audit and Feedback approach: study protocol for a stepped wedge cluster randomised trial: a study of the EASY-NET project.

INTRODUCTION: The ERAS protocol (Enhanced Recovery After Surgery) is a multimodal pathway aimed to reduce surgical stress and to allow a rapid postoperative recovery. Application of the ERAS protocol to colorectal cancer surgery has been limited to a minority of hospitals in Italy. To promote the systematic adoption of ERAS in the entire regional hospital network in Piemonte an Audit and Feedback approach (A&F) has been adopted together with a cluster randomised trial to estimate the true impact of the protocol on a large, unselected population. METHODS: A multicentre stepped wedge cluster randomised trial is designed for comparison between standard perioperative management and the management according to the ERAS protocol. The primary outcome is the length of hospital stay (LOS). Secondary outcomes are: incidence of postoperative complications, time to patients' recovery, control of pain and patients' satisfaction. With an A&F approach the adherence to the ERAS items is monitored through a dedicated area in the study web site. The study includes 28 surgical centres, stratified by activity volume and randomly divided into four groups. Each group is randomly assigned to a different activation period of the ERAS protocol. There are four activation periods, one every 3 months. However, the planned calendar and the total duration of the study have been extended by 6 months due to the COVID-19 pandemic.The expected sample size of about 2200 patients has a high statistical power (98%) to detect a reduction of LOS of 1 day and to estimate clinically meaningful changes in the other endpoints. ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethical Committee of the coordinating centre and by all participating centres. Study results will be timely circulated within the hospital network and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04037787.

Ultrasound-guided obturator nerve block: interfascial injection versus a neurostimulation-assisted technique.

BACKGROUND AND OBJECTIVES: Interfascial injection of local anesthetic under ultrasound guidance has been proposed as a new technique for performing an obturator nerve block. We hypothesized that interfascial needle placement could supplant nerve stimulation as the end point for local anesthetic injection during ultrasound-guided obturator nerve block after the division of the obturator nerve. METHODS: Fifty spinal anesthesia patients who had experienced unilateral adductor muscle spasm during transurethral bladder tumor resection were randomly allocated to receive either 5 mL of lidocaine 2% injected under ultrasound guidance into the interfascial plane between the adductor longus and the adductor brevis and between the adductor brevis and the magnus muscles (US group) or an injection of 5 mL of lidocaine 2% in combination with nerve stimulation after identification of the divisions of the obturator nerve (USENS group). At 5, 10, and 15 minutes after block placement, muscle spasm was assessed by an independent observer masked to treatment allocation. The primary outcome was motor block onset time. Secondary outcomes were block performance time, total anesthesia-related time, motor block success at 15 minutes, and number of needle passes. RESULTS: Motor block onset time did not differ between the 2 groups (6.2 minutes for USENS versus 7.2 minutes for US group, P = 0.225), block performance time was longer in the USENS than in the US group (3.0 versus 1.6 minutes, P < 0.001), and total anesthesia-related time did not differ between the 2 groups (9.2 versus 8.9 minutes, P = 0.71). Block success rate at 15 minutes was 100% in the USENS group and 88% in the US group (P = 0.23). There was no difference in the number of needle passes (2.3 versus 2.1, P = 0.28). CONCLUSIONS: In ultrasound-guided obturator nerve block performed after the division of the nerve, injection of local anesthetic between the planes of the adductor muscles is comparable to nerve stimulation.

Risk is not our business: safety of thoracic surgery in patients using antiplatelet therapy.

American Heart Association recommendations have changed preoperative management of patients with antiplatelet therapy (APT). We assessed safety and outcomes of surgery in patients who were receiving APT. A prospective study of patients operated on while receiving APT was matched with those with no APT (ratio 1:4), using the propensity score method. Logistic regression analysis was used to identify covariates among imbalanced baseline patient variables. Both χ(2) test and Fisher's test were used to calculate the probability value for the comparison of dichotomous variables. Between January 2008 and December 2010, 38 patients who received APT at the time of surgery were matched with 141 patients who had not received APT. APT indications were a history of myocardial infarction, coronary artery by-pass graft and/or valve replacement (19), coronary artery stent (11) and severe peripheral vascular disease (8). None of the patients required re-operation for bleeding. Two patients received blood transfusions. The amount of chest tube drainage was not statistically significantly different. There were no statistically significant differences between the outcomes for the operative time, length of hospital stay, estimated blood loss or morbidity. The results show that thoracic surgical procedures can safely be performed in patients receiving APT at the time of surgery, with no increased risk of bleeding or morbidity and no differences in the operative time and the length of hospital stay.