Association between anaemia and hospital readmissions in patients undergoing major surgery requiring postoperative intensive care.

Anaemia is a common sequela of surgery, although its relationship with patient recovery is unclear. The goal of this investigation was to assess the associations between haemoglobin concentrations at the time of hospital discharge following major surgery and early post-hospitalisation outcomes, with a primary outcome of 30 day unanticipated hospital readmissions. This investigation includes data from two independent population-based observational cohorts of adult surgical patients (aged ≥ 18 years) requiring postoperative intensive care unit admission between 1 January 2010 and 31 December 2019 in hospitals in Olmsted County, Minnesota, and between 1 July 2010 and 30 June 2017 in the Kaiser Permanente Northern California integrated healthcare system, California. Cox proportional hazards models assessed the associations between discharge haemoglobin concentrations (per 10 g.l-1 ) and outcomes, with prespecified multivariable adjustment. A total of 3260 patients were included from Olmsted County hospitals and 29,452 from Kaiser Permanente Northern California. In adjusted analyses, each 10 g.l-1 decrease in haemoglobin at hospital discharge was associated with a 9% (hazard ratio 1.09, 95%CI 1.02-1.18; p = 0.014) and 8% increase (hazard ratio 1.08, 95%CI 1.06-1.11; p < 0.001) in the hazard for readmission within 30 days in Olmsted County and Kaiser Permanente Northern California, respectively. In a sensitivity analysis exploring relationships across varying levels of pre-operative anaemia severity, these associations remained consistent, with lower discharge haemoglobin concentrations associated with higher readmissions irrespective of pre-operative anaemia severity. Anaemia at hospital discharge in surgical patients requiring postoperative intensive care is associated with increased rates of hospital readmission in two large independent cohorts. Future studies are necessary to evaluate strategies to prevent and/or treat anaemia in these patients for the improvement of post-hospitalisation outcomes.

Applying the Exploration, Preparation, Implementation, Sustainment (EPIS) Framework to Safe Surgery 2020 Implementation in Tanzania's Lake Zone.

BACKGROUND: Access to safe, high-quality surgical care in sub-Saharan Africa is a critical gap. Interventions to improve surgical quality have been developed, but research on their implementation is still at a nascent stage. We retrospectively applied the Exploration, Preparation, Implementation, Sustainment framework to characterize the implementation of Safe Surgery 2020, a multicomponent intervention to improve surgical quality. METHODS: We used a longitudinal, qualitative research design to examine Safe Surgery 2020 in 10 health facilities in Tanzania's Lake Zone. We used documentation analysis with confirmatory key informant interviews (n = 6) to describe the exploration and preparation phases. We conducted interviews with health facility leaders and surgical team members at 1, 6, and 12 months (n = 101) post initiation to characterize the implementation phase. Data were analyzed using the constant comparison method. RESULTS: In the exploration phase, research, expert consultation, and scoping activities revealed the need for a multicomponent intervention to improve surgical quality. In the preparation phase, onsite visits identified priorities and barriers to implementation to adapt the intervention components and curriculum. In the active implementation phase, 4 themes related to the inner organizational context-vision for safe surgery, existing surgical practices, leadership support, and resilience-and 3 themes related to the intervention-innovation-value fit, holistic approach, and buy-in-facilitated or hindered implementation. Interviewees perceived improvements in teamwork and communication and intra- and inter-facility learning, and their need to deliver safe surgery evolved during the implementation period. CONCLUSIONS: Examining implementation through the exploration, preparation, implementation, and sustainment phases offers insights into the implementation of interventions to improve surgical quality and promote sustainability.

The safety and effectiveness of salvianolate in preventing perioperative venous thromboembolism in China: A PRISMA-compliant meta-analysis based on RCTs.

BACKGROUND: Salvianolate, a common drug for stabilizing heart disease and Angina Pectoris, is considered to be off-label for preventing venous thromboembolism (VTE) or anticoagulation at present. However, many clinical studies have showed that salvianolate can effectively inhibit the deep-vein thrombosis (DVT) incidence, and prevent VTE of perioperative patients in the real world in China. OBJECTIVE: This analysis aimed to evaluate the effectiveness and safety of salvianolate in preventing VTE in perioperative patients. METHODS: Databases of PubMed, Cochrane Library, Embase, CNKI, Wanfang and VIP were searched until July 2019. Literature retrieval, data extraction and quality assessment were independently completed by two researchers and checked with each other. Review Manager 5.2 software was applied for meta-analysis. RESULTS: A total of 429 studies were retrieved, including 11 randomized controlled trials (RCTs) with a total of 1149 subjects. Compared with low molecular weight heparin (LMWH) group alone, salvianolate combined LMWH group had lower DVT incidence in preventing perioperative thrombosis (2.75% and 14.23%, OR: 0.21, 95% CI:[0.08,0.53]; P = .0009). The incidence of adverse reactions of experimental group was similar to that of control group (1.79% and 2.31%, OR: 0.65, 95% CI:[0.18,2.35]. P = .51). Compared with the control group, D-dimer level (D-D), platelet count (PLT), fibrinogen (FIB), whole blood high shear viscosity (WBHSV), and whole blood low shear viscosity (WBLSV) were all significantly decreased (P < .01), and prothrombin time (PT) was significantly increased (P < .05). CONCLUSION: Salvianolate combined LMWH has better effectiveness and the same safety in preventing venous thromboembolism in perioperative patients. However, due to the small number of included literatures, large sample studies are still needed to further verify this conclusion.

Research progress regarding potential effects of traditional Chinese medicine on postoperative intestinal obstruction.

OBJECTIVES: Postoperative intestinal obstruction is a common postoperative complication with typical symptoms of abdominal pain, vomiting, abdominal distension and constipation. The principal aim of this paper is to provide a full-scale review on the categories and characteristics of postoperative intestinal obstruction, pathophysiology, effects and detailed mechanisms of compounds and monomers from traditional Chinese medicine for treating postoperative intestinal obstruction. Moreover, the possible development and perspectives for future research are also analyzed. METHODS: Literature regarding postoperative intestinal obstruction as well as the anti-pio effect of aqueous extracts and monomers from traditional Chinese medicine in the last 20 years was summarized. KEY FINDINGS: To date, approximately 30 compounds and 25 monomers isolated from traditional Chinese medicine including terpenes, alkaloids, polysaccharides, flavonoids, phenylpropanoids and quinones, have exerted significant antipio effect. This paper reviews the effective doses, models, detailed mechanisms, and composition of these traditional Chinese medicine compounds, as well as the structure of these monomers. Moreover, challenges existed in the current investigation and further perspectives were discussed as well, hoping to provide a reference for future clinical treatment of postoperative intestinal obstruction and the development of new drugs. CONCLUSIONS: Above all, the convincing evidence from modern pharmacology studies powerfully supported the great potential of traditional Chinese medicine in the management of postoperative intestinal obstruction. Regrettably, less attention was currently paid on the mechanisms of traditional Chinese medicine compounds and monomers with antipio effect. Consequently, future study should focus on monomer-mechanism and structure-function relationship.

Adverse outcomes after major surgery in children with intellectual disability.

AIM: To evaluate outcomes after major surgery in children and adolescents with intellectual disability. METHOD: We used 2004 to 2013 claims data from Taiwan's National Health Insurance programme to conduct a nested cohort study, which included 220 292 surgical patients aged 6 to 17 years. A propensity score matching procedure was used to select 2173 children with intellectual disability and 21 730 children without intellectual disability for comparison. Logistic regression was used to calculate the adjusted odds ratios (ORs) and 95% confidence intervals (CIs) of the postoperative complications and 30-day mortality associated with intellectual disability. RESULTS: Children with intellectual disability had a higher risk of postoperative pneumonia (OR 2.16, 95% CI 1.48-3.15; p<0.001), sepsis (OR 1.67, 95% CI 1.28-2.18; p<0.001), and 30-day mortality (OR 2.04, 95% CI 1.05-3.93; p=0.013) compared with children without intellectual disability. Children with intellectual disability also had longer lengths of hospital stay (p<0.001) and higher medical expenditure (p<0.001) when compared with children with no intellectual disability. INTERPRETATION: Children with intellectual disability experienced more complications and higher 30-day mortality after surgery when compared with children without intellectual disability. There is an urgent need to revise the protocols for the perioperative care of this specific population. WHAT THIS PAPER ADDS: Surgical patients with intellectual disability are at increased risk of postoperative pneumonia, sepsis, and 30-day mortality. Intellectual disability is associated with higher medical expenditure and increased length of stay in hospital after surgical procedures. The influence of intellectual disability on postoperative outcomes is consistent in both sexes and those aged 10 to 17 years. Low income and a history of fractures significantly impacts postoperative adverse events for patients with intellectual disability.

[Advances in the prevention and treatment of postoperative ileus].

With the development and progress in the concepts and techniques of perioperative management, especially the latest reports of clinical trials, the prospect of prevention and treatment of postoperative ileus (POI) is promising. Proper nutritional support therapy, optimized surgical and anesthetic treatment, individualized fluid management, timely psychosocial intervention, and active anti-inflammation and traditional Chinese medicine treatment can effectively reduce occurrence of POI. Nevertheless, how to optimize and combine perioperative treatments to comprehensively prevent and treat POI still needs further study.

Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study).

BACKGROUND: Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. There is little evidence available for the curative setting after fistula occurrence. We hypothesize that EN increases the 30-day fistula closure rate in PUGIF, allowing better health-related quality of life without increasing the morbidity or mortality. METHODS/DESIGN: The NUTRILEAK trial is a multicenter, randomized, parallel-group, open-label phase III trial to assess the efficacy of EN (the experimental group) compared with TPN (the control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation) in terms of the 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate at 6 months after randomization, the fistula-related complication rate at 6 months after randomization, the type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month postrandomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 postrandomization, the mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment. A total of 321 patients will be enrolled. DISCUSSION: The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03742752. Registered on 14 November 2018.

Perioperative nutrition: Recommendations from the ESPEN expert group.

BACKGROUND & AIMS: Malnutrition has been recognized as a major risk factor for adverse postoperative outcomes. The ESPEN Symposium on perioperative nutrition was held in Nottingham, UK, on 14-15 October 2018 and the aims of this document were to highlight the scientific basis for the nutritional and metabolic management of surgical patients. METHODS: This paper represents the opinion of experts in this multidisciplinary field and those of a patient and caregiver, based on current evidence. It highlights the current state of the art. RESULTS: Surgical patients may present with varying degrees of malnutrition, sarcopenia, cachexia, obesity and myosteatosis. Preoperative optimization can help improve outcomes. Perioperative fluid therapy should aim at keeping the patient in as near zero fluid and electrolyte balance as possible. Similarly, glycemic control is especially important in those patients with poorly controlled diabetes, with a stepwise increase in the risk of infectious complications and mortality per increasing HbA1c. Immobilization can induce a decline in basal energy expenditure, reduced insulin sensitivity, anabolic resistance to protein nutrition and muscle strength, all of which impair clinical outcomes. There is a role for pharmaconutrition, pre-, pro- and syn-biotics, with the evidence being stronger in those undergoing surgery for gastrointestinal cancer. CONCLUSIONS: Nutritional assessment of the surgical patient together with the appropriate interventions to restore the energy deficit, avoid weight loss, preserve the gut microbiome and improve functional performance are all necessary components of the nutritional, metabolic and functional conditioning of the surgical patient.

Cardiogenic Shock in Perioperative and Intraoperative Settings: A Team Approach.

Cardiogenic shock (CS) is a multifactorial disease process with high morbidity and mortality. When it occurs in a peri- or intraoperative setting, factors such as surgery, anesthesia, and post-surgical physiology can negatively affect patient outcomes. Since patient needs often escalate during CS-from medications to mechanical support to palliative care-this disease demands a multidisciplinary approach that encompasses all aspects of medical delivery. Preliminary studies have indicated that a multidisciplinary team approach to CS results in earlier diagnosis and treatment and improves patient outcomes. Here we discuss various management strategies for CS from an anesthesiology, surgery, and critical care perspective.

An outpatient nursing nutritional intervention to prehabilitate undernourished patients planned for surgery: A multicentre, cluster-randomised pilot study.

BACKGROUND & AIMS: To improve the nutritional status of surgical patients before hospital admission, an Outpatient Nursing Nutritional Intervention (ONNI) was developed. The ONNI comprehends five components: determining causes of undernutrition, performing a nutritional care plan including tailored and general advice, self-monitoring of nutritional intake and eating patterns, counselling and encouragement, and conducting a follow-up telephone call to discuss improvements in nutritional behaviour. Here, we evaluate the feasibility and effectiveness of the ONNI. METHODS: In a multi-centred, cluster-randomised pilot study, nurses from outpatient clinics were randomly allocated to usual care (UC) or the ONNI. Patients planned for elective surgery were included if they were at increased risk for undernutrition based on the Malnutrition Universal Screening Tool (MUST) and hospital admission was not planned within seven days. Feasibility outcomes included participation rate, extent of intervention delivery, and patient satisfaction. Nutritional intake was monitored for two days before admission. Body weight, BMI and MUST scores at hospital admission were compared to measurements from the outpatient clinic visit. Data were analysed on an intention-to-treat basis by researchers who were blinded for patients and caregivers. RESULTS: Forty-eight patients enrolled the feasibility phase. Participation rate was 72%. Nurses delivered all intervention components adequately in the end of the implementation period. Finally, 152 patients (IG: n = 66, 43%) participated in the study. A significant difference in mean energy intake (870 kcal/d, 95%CI:630-1109 p < 0.000) and mean protein intake (34.1 g/d, 95%CI: 25.0-43.2; p < 0.000) was observed in favour of the IG. Nutritional energy requirements were achieved in 74% (n = 46) of the IG and in 17% (n = 13) of the UC group (p < 0.000), and protein requirements were achieved in 52% (n = 32) of the IG, compared to 8% (n = 6) of the UC group (p < 0.000). Body weight, BMI and MUST scores did not change in either group. CONCLUSIONS: The ONNI is a feasible and effective intervention tool for nurses at outpatient clinics. Patients in the IG had more nutritional intake and fulfilled nutritional requirements significantly more often than patients receiving UC. Further research is required to determine the optimal pre-operative timing of nutritional support and to measure its effect on other patients groups. CLINICAL TRIAL REGISTRATION: The study protocol was registered at the ClinicalTrial.gov website with the following identifier: NCT02440165.

Real-world utilization of andexanet alfa.

OBJECTIVE: In 2018, the FDA approved andexanet alfa for the reversal of life-threatening hemorrhages in patients anticoagulated with apixaban or rivaroxaban. Yet, cost-effective factor Xa inhibitor reversal remains controversial. The objective of this study was to describe real world utilization of andexanet alfa. METHODS: This was a retrospective case series of patients receiving andexanet alfa between July 28, 2018 and April 29, 2019 at a large academic health system. Baseline demographics, anticoagulant type and reversal, as well as brain imaging were collected. Primary endpoints were stability of hematoma for intracranial hemorrhage (ICH), and hemostatic effectiveness for patients undergoing surgical procedures. Secondary endpoints were thromboembolism and 30 day mortality. RESULTS: Of the 25 patients evaluated, 13 received andexanet alfa for ICH. Eleven of the 13 had follow-up imaging available and stability was observed in 90.9%. Three patients received andexanet alfa for reversal prior to surgical procedures, and 100% hemostatic effectiveness was achieved. Nine patients received andexanet alfa for reversal of extracranial bleeding, including gastrointestinal bleed (n=4). There were no thrombotic events in our cohort, and 30 day mortality was 24%. Sixty-four percent of patients would have met exclusion criteria for the ANNEXA-4 trial. CONCLUSION: This is the largest series to date describing real-world utilization of andexanet alfa. Our series showed hemostatic efficacy in 90.9% of patients with ICH, and 100% in patients undergoing surgical procedures. There were no thrombotic complications. Yet, larger and comparative studies are needed to clarify the optimal agent and patient selection for reversal of factor Xa inhibitors.

Experimental Study of Tumescence Injection to Provide Anesthesia Without Local Anesthetics.

BACKGROUND: One-per-mil tumescent technique could provide local anesthesia in surgical procedures despite using low lidocaine concentration. Tumescence environment within the tissue may play a role in supporting local anesthesia effect. This study aims to delineate whether the tumescence environment, created by one-per-mil solution without a local anesthetic agent, had a local anesthesia effect. METHODS: Four different compositions and volumes of tumescent solutions containing 1:1,000,000 epinephrine were injected into 50 Swiss Webster mice. The animals were divided into five groups: group A, a tumescent solution with 0.2% lidocaine; group B, a tumescent solution with 0.04% lidocaine; group C, a tumescent solution without lidocaine; group D, a doubled volume of tumescent solution without lidocaine; and group E, controls. Local anesthesia effects were tested by using the formalin test (n = 25) and tail immersion test (n = 25). Pain response behavior in the form of paw licking duration and tail withdrawal latency was observed. The analysis of variance and Kruskal-Wallis tests were used to test the statistical difference. Significance was set at P < 0.05. RESULTS: The four interventional groups showed less pain response behavior and significantly longer tail withdrawal latency (P < 0.05) than the control group. However, the groups showed nonsignificantly shorter paw licking duration than the control (P > 0.05). Group A had the fastest onset of the local anesthesia effect. CONCLUSIONS: The tumescence environment was potentially able to provide a local anesthesia effect, although the solution did not contain a local anesthetic agent as proved by the tail immersion test.

Perioperative Infusion of Glucagon-Like Peptide-1 Prevents Insulin Resistance After Surgical Trauma in Female Pigs.

Insulin resistance is an independent negative predictor of outcome after elective surgery and increases mortality among surgical patients in intensive care. The incretin hormone glucagon-like peptide-1 (GLP-1) potentiates glucose-induced insulin release from the pancreas but may also increase insulin sensitivity in skeletal muscle and directly suppress hepatic glucose release. Here, we investigated whether a perioperative infusion of GLP-1 could counteract the development of insulin resistance after surgery. Pigs were randomly assigned to three groups; surgery/control, surgery/GLP-1, and sham/GLP-1. Both surgery groups underwent major abdominal surgery. Whole-body glucose disposal (WGD) and endogenous glucose release (EGR) were assessed preoperatively and postoperatively using D-[6,6-2H2]-glucose infusion in combination with hyperinsulinemic euglycemic step-clamping. In the surgery/control group, peripheral insulin sensitivity (i.e., WGD) was reduced by 44% relative to preoperative conditions, whereas the corresponding decline was only 9% for surgery/GLP-1 (P < 0.05). Hepatic insulin sensitivity (i.e., EGR) remained unchanged in the surgery/control group but was enhanced after GLP-1 infusion in both surgery and sham animals (40% and 104%, respectively, both P < 0.05). Intraoperative plasma glucose increased in surgery/control (∼20%) but remained unchanged in both groups receiving GLP-1 (P < 0.05). GLP-1 diminished an increase in postoperative glucagon levels but did not affect skeletal muscle glycogen or insulin signaling proteins after surgery. We show that GLP-1 improves intraoperative glycemic control, diminishes peripheral insulin resistance after surgery, and suppresses EGR. This study supports the use of GLP-1 to prevent development of postoperative insulin resistance.

Geriatric Assessment, Not ASA Physical Status, Is Associated With 6-Month Postoperative Survival in Patients With Cancer Aged ≥75 Years.

BACKGROUND: The American Society of Anesthesiologists physical status (ASA PS) classification system is the most common method of assessing preoperative functional status. Comprehensive geriatric assessment (CGA) has been proposed as a supplementary tool for preoperative assessment of older adults. The goal of this study was to assess the correlation between ASA classification and CGA deficits among oncogeriatric patients and to determine the association of each with 6-month survival. PATIENTS AND METHODS: Oncogeriatric patients (aged ≥75 years) who underwent preoperative CGA in an outpatient geriatric clinic at a single tertiary comprehensive cancer center were identified. All patients underwent surgery, with a hospital length of stay (LOS) ≥1 day and at least 6 months of follow-up. ASA classifications were obtained from preoperative anesthesiology notes. Preoperative CGA scores ranged from 0 to 13. Six-month survival was assessed using the Social Security Death Index. RESULTS: In total, 81 of the 980 patients (8.3%) included in the study cohort died within 6 months of surgery. Most patients were classified as ASA PS III (85.4%). The mean number of CGA deficits for patients with PS II was 4.03, PS III was 5.15, and PS IV was 6.95 (P<.001). ASA classification was significantly associated with age, preoperative albumin level, hospital LOS, and 30-day intensive care unit (ICU) admissions. On multivariable analysis, 6-month mortality was associated with number of CGA deficits (odds ratio [OR], 1.14 per each unit increase in CGA score; P=.01), 30-day ICU admissions (OR, 2.77; P=.003), hospital LOS (OR, 1.03; P=.02), and preoperative albumin level (OR, 0.36; P=.004). ASA classification was not associated with 6-month mortality. CONCLUSIONS: Number of CGA deficits was strongly associated with 6-month mortality; ASA classification was not. Preoperative CGA elicits critical information that can be used to enhance the prediction of postoperative outcomes among older patients with cancer.

Non-needle acupoint stimulation for prevention of nausea and vomiting after breast surgery: A meta-analysis.

BACKGROUND: Breast disease has been a global serious health problem, among women. Surgery is the main treatment for the patients suffering from breast disease. Postoperative nausea and vomiting are still disturbing. Acupoint stimulation, an effective treatment of traditional Chinese medicine, has been used to reduce postoperative nausea and vomiting. Recently, non-needle acupoint stimulation becomes a new intervention. Though several clinical trials have been done, there is still no final conclusion on the efficacy. This Meta-Analysis aims at evaluating the efficacy of non-needle acupoint stimulation for prevention of nausea and vomiting after breast surgery. METHODS: Systematic searches were conducted in PubMed, Embase, Cochrane, and Wanfang Med Online databases for studies. The review period covered from the inception of databases to December 31, 2017. The outcome measures of interest were frequency of nausea, frequency of vomiting, frequency of PONV, verbal rating scale of nausea, and use of rescue antiemetic. Data extraction and risks of bias evaluation were accomplished by 2 independent reviewers using the Cochrane Collaboration Review Manager software (RevMan 5.3.5). RESULTS: Fourteen randomized controlled trials with a total of 1009 female participants in the non-needle acupoint stimulation group and control group met the inclusion criteria. Although the therapeutically effect on vomiting within postoperative 2 hours was not obvious, non-needle acupoint stimulation still had an important role in reducing nausea and vomiting within postoperative 48 hours. According to Jadad scale, there was moderate quality evidence for the pooled analysis results in this study. In addition, stimulating acupoint by wristband acupressure was more likely to cause adverse reactions. CONCLUSION: Non-needle acupoint stimulation can be used for female patients undergoing breast surgery to reduce postoperative nausea and vomiting. Into consideration, we recommend transcutaneous acupoint electrical stimulation on PC6 from 30 minutes before induction of anesthesia to the end of surgery for application. This non-pharmaceutical approach may be promising to promote the recovery of patients after breast surgery.

Yokukansan for perioperative psychiatric symptoms in cancer patients undergoing high invasive surgery. J-SUPPORT 1605 (ProD Study): study protocol for a randomized controlled trial.

BACKGROUND: Preoperative anxiety and postoperative delirium affect both short- and long-term prognoses in patients with cancer; therefore, these conditions require early prevention and treatment. However, no standard preventive or therapeutic methods have been established for them. Yokukansan, a Japanese herbal medicine for the treatment of insomnia and anxiety, causes relatively few adverse drug reactions and effectively improves the behavioral and psychological symptoms of dementia. Thus, it is expected to be useful for treating and/or preventing perioperative psychiatric symptoms in patients with cancer. The objective of this study is to clarify the therapeutic effect of Yokukansan for preoperative anxiety and its preventive effect on postoperative delirium in cancer patients, as well as to confirm its safety profile. METHODS: This study is a randomized, double-blind, placebo-controlled study in cancer patients scheduled to undergo tumor resection. Patients who provide consent are randomly allocated to receive oral administration of Yokukansan or placebo, and study drug administration is continued for 4 days or longer prior to surgery. We defined two primary endpoints, change in preoperative anxiety and incidence of postoperative delirium. Secondary endpoints are severity score of postoperative delirium, duration of postoperative delirium, amount of benzodiazepines used prior to surgery, amount of antipsychotic agents used after surgery, and number of postoperative hospitalization days. We plan to complete the analysis on March 31, 2021. The target number of registered patients is 110 per group, or 220 in total. DISCUSSION: This study is the first randomized, double-blind, placebo-controlled study intended to clarify the effects of a Japanese herbal medicine, Yokukansan, in the prevention and treatment of perioperative psychiatric symptoms in patients with cancer. The trial was initiated on August 14, 2017, with 195 subjects randomized by October 5, 2018. TRIAL REGISTRATION: UMIN Clinical Trials Registry (UMIN-CTR), UMIN000027561 . Registered on 31 May 2017.

Prehabilitation is better than cure.

PURPOSE OF REVIEW: With a continuously growing number of older patients undergoing major surgical procedures, reliable parameters practicable in perioperative routine revealing those patients at risk are urgently needed. Recently, the concept of 'prehabilitation' with its key elements exercise, nutrition and psychological stress reduction especially in frail patients is attracting increasing attention. RECENT FINDINGS: Literature search revealed a huge amount of publications in particular within the last 12 months. Although a single definition of both frailty and prehabilitation is still to be made, various players in the perioperative setting obviously are becoming increasingly convinced about a possible benefit of the program - referring to different components and measures performed. Although physiologically advantages seem obvious, there is hardly any reliable data on clinical outcomes resulting from properly performed studies. This applies especially to octogenarians; thus those at risk for adverse events the concept originally addresses. SUMMARY: Identifying high-risk patients at the earliest possible stage and increasing their physiological reserve prior to surgery is a promising approach that seems to result in remarkable improvements for older patients. However, further studies on effectiveness in a highly heterogeneous population and agreement on a common concept are mandatory before a final judgement can be given.