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Background The aim of this trial was to compare the Enhanced Recovery After Surgery (ERAS) program with conventional perioperative management in patients who underwent radical resection for colorectal cancer. Methods A combination of evidence-based and consensus methodology was used to develop the ERAS protocol. Five hundred ninety-seven consecutive patients who underwent elective colorectal resection were randomized to either the ERAS ( n  = 299) or the control group ( n  = 298). Outcomes relating to nutrition and metabolism index, stress index, and recovery index were measured and recorded. Results Demographic and operative data were similar between the two groups. Patients in the ERAS group showed improved nutritional status when compared with those of the control group. On postoperative day (POD) 1, the HOMA-IR (insulin resistance index) of the ERAS group was lower than that of the control group ( p  < 0.001). The cortisol level of the control group was elevated on both POD 1 ( p  = 0.007) and POD 5 ( p  = 0.002) compared to the preoperative level. However, the cortisol level of the ERAS group was not increased until POD 5 ( p  = 0.001). Reduced levels of TNF-α, IL-1β, IL-6, and IFN-γ in the ERAS group indicated less postoperative stress responses. In addition, ERAS was associated with accelerated recovery of gastrointestinal function. The postoperative length of stay ( p  < 0.001) and expense ( p  < 0.001) for the ERAS group were reduced in comparison to the controls. Twenty-eight cases in the control group and twenty-nine in the ERAS group suffered complications, which was not significantly different. Conclusion The ERAS protocol attenuates the surgical stress response and accelerates postoperative recovery without compromising patient safety.

Objective The aim of this study was to evaluate the safety and effectiveness of fast-track surgery combined with laparoscopy-assisted radical distal gastrectomy for gastric cancer. Methods Eighty-eight eligible patients were randomly assigned into four groups: (1) fast-track surgery (FTS) + laparoscopy-assisted radical distal gastrectomy (LADG), treated with LADG and FTS treatment; (2) LADG, treated with LADG and traditional treatment; (3) FTS + open distal grastectomy (ODG), treated with ODG and FTS treatment; and (4) ODG, treated with ODG and traditional treatment. The clinical parameters and serum indicators were compared. Results Compared with the ODG group, the other three groups had earlier first flatus and shorter postoperative hospital stay (all P  <0.01; all P  <0.05), especially in the FTS + LADG group. The level of ALB was higher in the FTS + LADG group than in the LADG group at 4 and 7 days after surgery ( P  <0.05, P  <0.01). The level of CRP in the FTS + LADG group was lower than in the FTS+ODG group at 4 and 7 days after surgery ( P  <0.05, P  <0.05). The FTS + ODG group had lowest medical costs. Conclusion Combination of FTS and LADG in gastric cancer is safe, feasible, and efficient and can improve nutritional status, lessen postoperative stress, and accelerate postoperative rehabilitation. Compared with FTS + ODG and LADG, its advantages were limited in short-term follow-up.

IntroductionBiological disease-modifying antirheumatic drugs (bDMARDs) have revolutionised the treatment of inflammatory arthritis (IA). However, many people with IA still require planned orthopaedic surgery to reduce pain and improve function. Currently, bDMARDs are withheld during the perioperative period due to potential infection risk. However, this predisposes patients to IA flares and loss of disease control. The question of whether to stop or continue bDMARDs in the perioperative period has not been adequately addressed in a randomised controlled trial (RCT).Methods and analysisPERISCOPE is a multicentre, superiority, pragmatic RCT investigating the stoppage or continuation of bDMARDs. Participants will be assigned 1:1 to either stop or continue their bDMARDs during the perioperative period. We aim to recruit 394 adult participants with IA. Potential participants will be identified in secondary care hospitals in the UK, screened by a delegated clinician. If eligible and consenting, baseline data will be collected and randomisation completed. The primary outcome will be the self-reported PROMIS-29 (Patient Reported Outcome Measurement Information System) over the first 12 weeks postsurgery. Secondary outcome measures are as follows: PROMIS - Health Assessment Questionnaire (PROMIS-HAQ), EQ-5D-5L, Disease activity: generic global Numeric Rating Scale (patient and clinician), Self-Administered Patient Satisfaction scale, Health care resource use and costs, Medication use, Surgical site infection, delayed wound healing, Adverse events (including systemic infections) and disease-specific outcomes (according to IA diagnosis). The costs associated with stopping and continuing bDMARDs will be assessed. A qualitative study will explore the patients’ and clinicians’ acceptability and experience of continuation/stoppage of bDMARDs in the perioperative period and the impact postoperatively.Ethics and disseminationEthical approval for this study was received from the West of Scotland Research Ethics Committee on 25 April 2023 (REC Ref: 23/WS/0049). The findings from PERISCOPE will be submitted to peer-reviewed journals and feed directly into practice guidelines for the use of bDMARDs in the perioperative period.Trial registration numberISRCTN17691638.

ObjectivesTo evaluate the cost-effectiveness and cost-utility of an internet-based perioperative care programme compared with usual care for gynaecological patients.DesignEconomic evaluation from a societal perspective alongside a stepped-wedge cluster-randomised controlled trial with 12 months of follow-up.SettingSecondary care, nine hospitals in the Netherlands, 2011–2014.Participants433 employed women aged 18–65 years scheduled for a hysterectomy and/or laparoscopic adnexal surgery.InterventionThe intervention comprised an internet-based care programme aimed at improving convalescence and preventing delayed return to work (RTW) following gynaecological surgery and was sequentially rolled out. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or to the intervention (n=227).Main outcome measuresThe primary outcome was duration until full sustainable RTW. Secondary outcomes were quality-adjusted life years (QALYs), health-related quality of life and recovery.ResultsAt 12 months, there were no statistically significant differences in total societal costs (€−647; 95% CI €−2116 to €753) and duration until RTW (−4.1; 95% CI −10.8 to 2.6) between groups. The incremental cost-effectiveness ratio (ICER) for RTW was 56; each day earlier RTW in the intervention group was associated with cost savings of €56 compared with usual care. The probability of the intervention being cost-effective was 0.79 at a willingness-to-pay (WTP) of €0 per day earlier RTW, which increased to 0.97 at a WTP of €76 per day earlier RTW. The difference in QALYs gained over 12 months between the groups was clinically irrelevant resulting in a low probability of cost-effectiveness for QALYs.ConclusionsConsidering that on average the costs of a day of sickness absence are €230, the care programme is considered cost-effective in comparison with usual care for duration until sustainable RTW after gynaecological surgery for benign disease. Future research should indicate whether widespread implementation of this care programme has the potential to reduce societal costs associated with gynaecological surgery.Trial registration number NTR2933; Results.

Background This study is initiated to evaluate the effects, costs, and feasibility at the hospital and patient level of an evidence-based strategy to improve the use of Dutch perioperative safety guidelines. Based on current knowledge, expert opinions and expertise of the project team, a multifaceted implementation strategy has been developed. Methods/design This is a stepped wedge cluster randomized trial including nine representative hospitals across The Netherlands. Hospitals are stratified into three groups according to hospital type and geographical location and randomized in terms of the period for receipt of the intervention. All adult surgical patients meeting the inclusion criteria are assessed for patient outcomes. The implementation strategy includes education, audit and feedback, organizational interventions (e.g., local embedding of the guidelines), team-directed interventions (e.g., multi-professional team training), reminders, as well as patient-mediated interventions (e.g., patient safety cards). To tailor the implementation activities, we developed a questionnaire to identify barriers for effective guideline adherence, based on (a) a theoretical framework for classifying barriers and facilitators, (b) an instrument for measuring determinants of innovations, and (c) 19 semi-structured interviews with perioperative key professionals. Primary outcome is guideline adherence measured at the hospital (i.e., cluster) and patient levels by a set of perioperative Patient Safety Indicators (PSIs), which was developed parallel to the perioperative guidelines. Secondary outcomes at the patient level are in-hospital complications, postoperative wound infections and mortality, length of hospital stay, and unscheduled transfer to the intensive care unit, non-elective readmission to the hospital and unplanned reoperation, all within 30 days after the initial surgery. Also, patient safety culture and team climate will be studied as potential determinants. Finally, a process evaluation is conducted to identify the compliance with the implementation strategy, as well as an economic evaluation to assess the costs. Data sources are registered clinical data and surveys. There is no form of blinding. Discussion The perioperative setting is an unexplored area with respect to implementation issues. This study is expected to yield important new evidence about the effects of a multifaceted approach on guideline adherence in the perioperative care setting. Trial registration Dutch trial registry: NTR3568

To describe the main findings of the Portland Diabetic Project, which elucidates the adverse relationship between hyperglycemia and outcomes of cardiac surgical procedures in patients with diabetes and delineates the protective effects of intravenous insulin therapy in reducing those adverse outcomes. In this ongoing 17-year prospective, nonrandomized, interventional study of 4,864 patients with diabetes who underwent an open-heart surgical procedure, we investigated the effects of hyperglycemia, and its subsequent reduction by continuous intravenous insulin (CII) therapy, on in-hospital outcomes. Increasing blood glucose levels were found to be directly associated with increasing rates of death, deep sternal wound infections (DSWI), length of hospital stay (LOS), and hospital cost. In separate multivariate analyses, increasing hyperglycemia was found to be independently predictive of increasing mortality (P<0.0001), DSWI (P = 0.017), and LOS (P<0.002). Conversely, CII therapy, designed to achieve predetermined target blood glucose levels, independently reduced the risks of death and DSWI by 57% and 66%, respectively (P<0.0001 for both). Target blood glucose levels of less than 150 mg/dL and a 3-day postoperative duration of CII therapy are both important variables that determine the effect of the CII therapy on improved outcomes. Coronary artery bypass grafting-related mortality (2.5%) and DSWI rates (0.8%) in patients with diabetes were normalized to those of the nondiabetic population by the use of the Portland CII Protocol. Perioperative hyperglycemia in patients undergoing a cardiac surgical procedure affects biochemical and physiologic functions, which, in turn, adversely alter mortality, LOS, and infection rates. The Portland CII Protocol is a cost-efficient method that effectively eliminates hyperglycemia and reduces postoperative morbidity and mortality in patients with diabetes undergoing an open-heart operation. CII protocols should be the standard care for glycometabolic control in all patients undergoing cardiac surgical procedures.

Short-acting regional anesthetics have already been successfully used for peripheral nerve blocks in an ambulatory surgery setting. However, the impact on direct and indirect perioperative costs comparing 2 different short-acting local anesthetics has not been performed yet. Observational, prospective, case-control, cost-minimization study. Operating room, regional hospital One hundred adult American Society of Anesthesiologists status I-III patients scheduled for popliteal block after minor ambulatory foot surgery. Application of 30 mL chloroprocaine 3% or of 30 mL mepivacaine 1.5% for anesthesia. Cost-minimization evaluation. Direct and indirect perioperative costs were calculated. Block success, onset time and block duration, patient satisfaction, and unplanned outpatient visits or readmissions after discharge were also assessed. Onset time (sensory: 4.3 ± 2.4 vs 11.5 ± 3.2 minutes; motor: 7.1 ± 3.7 vs 18.4 ± 4.5 minutes) and block duration (sensory: 105 ± 26 vs 317 ± 46 minutes; motor: 91 ± 25 vs 216 ± 31 minutes) were significantly shorter (P < .001) when chloroprocaine 3% was used. This translated to P < .001, basically due to a faster discharge home 55 ± 1 vs 175 ± 2 minutes; P < .001) in favor of chloroprocaine 3%, without negatively affecting either block efficacy or patients satisfaction. There were no unplanned outpatient visits or readmissions and no complications in the follow-up at 6 weeks. We conclude that the more expensive chloroprocaine 3% for ambulatory foot surgery can reduce total perioperative costs and reduce length of stay in outpatient patients. Moreover, the saved time and personal resources could be used for additional cases, further increasing the revenues of an ambulatory surgical center. •Cost reduction is an extremely hot topic in perioperative medicine.•A faster discharge is associated to fix cost reduction and increased turnover in ambulatory surgery.•A case-control cost-minimization study to compare chloroprocaine with mepivacaine for outpatient popliteal block was performed.•Chloroprocaine was shown to be as effective as mepivacaine but was associated with a reduction in total costs.

General anesthesia (GA) is the most commonly used anesthetic technique for spinal surgery. This study aimed to compare spinal anesthesia (SA) and GA in patients undergoing spinal surgery, in terms of perioperative outcome and cost effectiveness. The study included 80 patients with ASA (American Society of Anesthesiologists) physical status I–II. The patients were randomized to receive SA (n=40) or GA (n=40). Heart rate (HR), mean arterial blood pressure (MABP), blood loss, duration of surgery, duration of anesthesia, surgeon satisfaction, and duration in the post-anesthesia care unit (PACU) were recorded. Postoperative analgesic requirement, nausea and vomiting (PONV), perioperative hemodynamic variables, and anesthetic costs were determined. HR and MABP were significantly higher in the GA group than in the SA group at the end of surgery and at PACU admission. Duration of anesthesia, surgeon satisfaction, postoperative analgesic requirement, and anesthetic costs were significantly higher in the GA group. Mean blood loss was lower in the SA group than in the GA group, but the difference was not significant. Duration of surgery, duration in the PACU, perioperative hemodynamic variables, and complications were similar in both groups. SA could be considered a reliable alternative to GA in patients undergoing lumber spine surgery, as it is clinically as effective as GA, but more cost effective.

Background Patients with hazardous alcohol intake are overrepresented in emergency departments and surgical wards. These patients have an increased risk of postoperative complications with prolonged hospital stays and admissions to intensive care unit after surgery. In elective surgery, preoperative alcohol cessation interventions can reduce postoperative complications, but no studies have investigated the effect of alcohol cessation intervention at the time of acute fracture surgery. This protocol describes a randomised clinical trial that aims to evaluate the effect of a new gold standard programme for alcohol cessation intervention in the perioperative period regarding postoperative complications, alcohol intake and cost-effectiveness. Methods/Design Patients with hazardous alcohol intake undergoing ankle fracture surgery will be recruited into the trial from multiple orthopaedic wards at university hospitals in Denmark, Sweden and Norway. Included patients will be randomly allocated to either standard care or the gold standard programme aimed at complete alcohol abstinence before, during and 6 weeks after surgery. It includes a structured patient education programme and weekly interventions meetings at the orthopaedic outpatient clinic. Furthermore, patients are provided with thiamine and B-vitamins, alcohol withdrawal prophylaxis and treatment, and disulfiram to support abstinence. Alcohol intake is biochemically validated (blood, urine and breath tests) at the weekly intervention meetings and follow-up visits. Follow-up assessments will be conducted 6 weeks and 3, 6, 9 and 12 months after surgery for all patients. The effect of the gold standard programme will be assessed comparing the outcome measures between the intervention and control group at each follow-up point. Discussion The study will provide new knowledge about how to prevent alcohol-related postoperative complications at the time of acute fracture surgery. If effective, the results will be a benefit for the clinical course, patients and society alike. Trial registration The protocol is registered in ClinicalTrials.gov (Id: NCT00986791 ).

Background Recent studies have shown the efficacy of perioperative immunotherapy in improving the event-free survival of patients with advanced resectable melanoma. This study evaluated the cost-effectiveness of different perioperative immunotherapy treatment strategies versus adjuvant immunotherapy treatment strategies from the US payer perspective. Methods Two immunotherapy strategies were each compared with the corresponding standard adjuvant treatment in two Markov models: Model (1) perioperative nivolumab plus ipilimumab versus adjuvant nivolumab for stage III patients; model (2) perioperative pembrolizumab versus adjuvant pembrolizumab for stage IIIB to IVC patients. Primary outcomes included direct costs, life-year gained (LYG), quality-adjusted life-year (QALY), and incremental cost per QALY (ICER). Sensitivity analyses were conducted to evaluate the robustness of the model outcomes. Results In base-case analysis, perioperative nivolumab plus ipilimumab (versus adjuvant nivolumab) gained higher QALY (by 2.73) with cost-saving (by USD109,157) in model (1), and perioperative pembrolizumab (versus adjuvant pembrolizumab) gained higher QALY (by 2.29) with cost-saving (by USD130,157) in model (2). Both perioperative strategies were accepted as cost-effective. One-way sensitivity analyses found the base-case results robust to variation in all model parameters at willingness-to-pay threshold of 100,000 USD/QALY. Probabilistic sensitivity analysis demonstrated that the two perioperative strategies were accepted as cost-effective in 100% of 10,000 simulations. Conclusions Perioperative immunotherapies demonstrated cost-saving compared with adjuvant immunotherapies from the US payer perspective. One-way and probabilistic sensitivity analyses supported the robustness of the cost-effectiveness results. Clinical trial number Not applicable.