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Impact of enhanced recovery after surgery protocols versus standard of care on perioperative outcomes of radical cystectomy: a systematic review and meta-analysis of comparative studies.
Giannarini, G, Crestani, A, Inferrera, A, Rossanese, M, Subba, E, Novara, G, Ficarra, V
Minerva urologica e nefrologica = The Italian journal of urology and nephrology. 2019;(4):309-323
Abstract
INTRODUCTION Among the measures taken in the recent years to reduce the morbidity and improve functional recovery after radical cystectomy (RC), the optimization of perioperative care pathways is gaining a prominent role. The aim of this systematic review of the literature with meta-analysis is to assess the impact of enhanced recovery after surgery (ERAS) protocols vs. standard of care on perioperative outcomes of patients undergoing RC. EVIDENCE ACQUISITION A systematic review with meta-analysis was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. MEDLINE, SCOPUS and Web of Science databases were searched. Only comparative studies evaluating the impact of ERAS protocols vs. standard of care on intraoperative and postoperative outcomes of patients undergoing RC were included. Cumulative analysis was conducted using Review Manager v.5.3 software. Statistical heterogeneity was tested using the χ2 Test, and a P value <0.10 was used to indicate heterogeneity. Random-effects and fixed-effects models were used as appropriate depending on heterogeneity status. EVIDENCE SYNTHESIS A total of 27 studies were included, namely 3 randomized and 24 non-randomized controlled studies, resulting in 4712 patients, 2690 (57%) participants to some ERAS protocol and 2022 (43%) controls receiving standard of care. A number of primary and secondary outcome measures were assessed in the original studies. Pooled data showed that ERAS protocols were associated with significantly faster recovery of bowel function, faster return to regular diet and shorter hospital stay with no increase in 30-day and 90-day major complication, mortality or readmission rates compared to standard of care. The magnitude of benefit of the various ERAS protocols tested had, however, a non-negligible inter-study variability. CONCLUSIONS This systematic review with meta-analysis of comparative studies showed that ERAS protocols applied to patients undergoing RC enabled a faster recovery of bowel function, a faster return to regular diet and a shorter hospital stay with no increase in major complication or readmission rate compared to standard perioperative care. RC with ERAS protocols should be considered the new standard of care.
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Balanced Crystalloids Versus Saline for Perioperative Intravenous Fluid Administration in Children Undergoing Neurosurgery: A Randomized Clinical Trial.
Lima, MF, Neville, IS, Cavalheiro, S, Bourguignon, DC, Pelosi, P, Malbouisson, LMS
Journal of neurosurgical anesthesiology. 2019;(1):30-35
Abstract
BACKGROUND Balanced crystalloid solutions induce less hyperchloremia than normal saline, but their role as primary fluid replacement for children undergoing surgery is unestablished. We hypothesized that balanced crystalloids induce less chloride and metabolic derangements than 0.9% saline solutions in children undergoing brain tumor resection. METHODS In total, 53 patients (age range, 6 mo to 12 y) were randomized to receive balanced crystalloid (balanced group) or 0.9% saline solution (saline group) during and after (for 24 h) brain tumor resection. Serum electrolyte and arterial blood gas analyses were performed at the beginning of surgery (baseline), after surgery, and at postoperative day 1. The primary trial outcome was the absolute difference in serum chloride concentrations (post-preopΔCl) measured after surgery and at baseline. Secondary outcomes included the post-preopΔ of other electrolytes and base excess (BE); hyperchloremic acidosis incidence; and the brain relaxation score, a 4-point scale evaluated by the surgeon for assessing brain edema. RESULTS Saline infusion increased post-preopΔCl (6 [3.5; 8.5] mmol/L) compared with balanced crystalloid (0 [-1.0; 3.0] mmol/L; P<0.001). Saline use also resulted in increased post-preopΔBE (-4.4 [-5.0; -2.3] vs. -0.4 [-2.7; 1.3] mmol/L; P<0.001) and hyperchloremic acidosis incidence (6/25 [24%] vs. 0; P=0.022) compared with balanced crystalloid. Brain relaxation score was comparable between groups. CONCLUSIONS In children undergoing brain tumor resection, saline infusion increased variation in serum chloride compared with balanced crystalloid. These findings support the use of balanced crystalloid solutions in children undergoing brain tumor resection.
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Glycaemic efficacy and safety of linagliptin compared to a basal-bolus insulin regimen in patients with type 2 diabetes undergoing non-cardiac surgery: A multicentre randomized clinical trial.
Vellanki, P, Rasouli, N, Baldwin, D, Alexanian, S, Anzola, I, Urrutia, M, Cardona, S, Peng, L, Pasquel, FJ, Umpierrez, GE, et al
Diabetes, obesity & metabolism. 2019;(4):837-843
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AIMS: The use of incretin-based therapy, rather than or complementary to, insulin therapy is an active area of research in hospitalized patients with type 2 diabetes (T2D). We determined the glycaemic efficacy and safety of linagliptin compared to a basal-bolus insulin regimen in hospitalized surgical patients with T2D. MATERIALS AND METHODS This prospective open-label multicentre study randomized T2D patients undergoing non-cardiac surgery with admission blood glucose (BG) of 7.8 to 22.2 mmol/L who were under treatment with diet, oral agents or total insulin dose (TDD) ≤ 0.5 units/kg/day to either linagliptin (n = 128) daily or basal-bolus (n = 122) with glargine once daily and rapid-acting insulin before meals. Both groups received supplemental insulin for BG > 7.8 mmol/L. The primary endpoint was difference in mean daily BG between groups. RESULTS Mean daily BG was higher in the linagliptin group compared to the basal-bolus group (9.5 ± 2.6 vs 8.8 ± 2.3 mmol/L/dL, P = 0.03) with a mean daily BG difference of 0.6 mmol/L (95% confidence interval 0.04, 1.2). In patients with randomization BG < 11.1 mmol/L (63% of cohort), mean daily BG was similar in the linagliptin and basal-bolus groups (8.9 ± 2.3 vs 8.7 ± 2.3 mmol/L, P = 0.43); however, patients with BG ≥ 11.1 mmol/L who were treated with linagliptin had higher BG compared to the basal-bolus group (10.9 ± 2.6 vs 9.2 ± 2.2 mmol/L, P < 0.001). Linagliptin resulted in fewer hypoglycaemic events (1.6% vs 11%, P = 0.001; 86% relative risk reduction), with similar supplemental insulin and fewer daily insulin injections (2.0 ± 3.3 vs 3.1 ± 3.3, P < 0.001) compared to the basal-bolus group. CONCLUSIONS For patients with T2D undergoing non-cardiac surgery who presented with mild to moderate hyperglycaemia (BG < 11.1 mmol/L), daily linagliptin is a safe and effective alternative to multi-dose insulin therapy, resulting in similar glucose control with lower hypoglycaemia.
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Multicentre factorial randomized clinical trial of perioperative immunonutrition versus standard nutrition for patients undergoing surgical resection of oesophageal cancer.
Mudge, LA, Watson, DI, Smithers, BM, Isenring, EA, Smith, L, Jamieson, GG, ,
The British journal of surgery. 2018;(10):1262-1272
Abstract
BACKGROUND Preoperative immunonutrition has been proposed to reduce the duration of hospital stay and infective complications following major elective surgery in patients with gastrointestinal malignancy. A multicentre 2 × 2 factorial RCT was conducted to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with oesophageal cancer. METHODS Patients were randomized before oesophagectomy to immunonutrition (IMPACT® ) versus standard isocaloric/isonitrogenous nutrition, then further randomized after operation to immunonutrition versus standard nutrition. Clinical and quality-of-life outcomes were assessed at 14 and 42 days after operation on an intention-to-treat basis. The primary outcome was the occurrence of infective complications. Secondary outcomes were other complications, duration of hospital stay, mortality, nutritional and quality-of-life outcomes (EuroQol EQ-5D-3 L™, European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC QLQ-OES18). Patients and investigators were blinded until the completion of data analysis. RESULTS Some 278 patients from 11 Australian sites were randomized; two were excluded and data from 276 were analysed. The incidence of infective complications was similar for all groups (37 per cent in perioperative standard nutrition group, 51 per cent in perioperative immunonutrition group, 34 per cent in preoperative immunonutrition group and 40 per cent in postoperative immunonutrition group; P = 0·187). There were no significant differences in any other clinical or quality-of-life outcomes. CONCLUSION Use of immunonutrition before and/or after surgery provided no benefit over standard nutrition in patients undergoing oesophagectomy. Registration number: ACTRN12611000178943 ( https://www.anzctr.org.au).
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Introducing TOPMAST, the first double-blind randomized clinical trial specifically dedicated to perioperative maintenance fluid therapy in adults.
Hendrickx, S, Van Vlimmeren, K, Baar, I, Verbrugghe, W, Dams, K, Van Cromphaut, S, Roelant, E, Embrecht, B, Wittock, A, Mertens, P, et al
Anaesthesiology intensive therapy. 2017;(5):366-372
Abstract
BACKGROUND Although prescribed to every patient undergoing surgery, maintenance fluid therapy is a poorly researched part of perioperative fluid therapy. The tonicity of the chosen solutions, could be an important cause of morbidity, with hyponatremia being a potential side effect of hypotonic solutions, where isotonic solution could lead to fluid overload. METHODS The TOPMAST-trial is an ongoing prospective single-center double-blind randomized trial comparing an isotonic and a hypotonic maintenance fluid strategy during and after surgery in patients undergoing different types of major thoracic surgery. Patients receive NaCl 0.9% in glucose 5% with an added 40 mmol L-1 of potassium chloride or a premixed solution containing 54 mmol L-1 sodium, 55 mmol L-1 chloride and 26 mmol of potassium at a rate of 27 mL per kg of body weight per day. The primary hypothesis is that isotonic maintenance solutions cause a more positive perioperative fluid balance than hypotonic fluids. Different secondary safety endpoints will be explored, especially the effect of the study treatments on the occurrence electrolyte disturbances (e.g. hyponatremia, hyperchloremia) and a set of clinical endpoints. Efficacy endpoints include the need for resuscitation fluids and assessment of renal and hormonal adaptive mechanisms. An anticipated 68 patients will be included between March 2017 and January 2018. DISCUSSION The study will provide the most comprehensive evaluation of clinically important outcomes associated with the choice of perioperative maintenance fluid therapy.
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[Not Available].
Graf, L, Korte, W
Therapeutische Umschau. Revue therapeutique. 2016;(10):545-549
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Efficacy of Different Perioperative Statin Regimens on Protection Against Post-Coronary Artery Bypass Grafting Major Adverse Cardiac and Cerebral Events.
Elmarsafawi, AG, Abbassi, MM, Elkaffas, S, Elsawy, HM, Sabry, NA
Journal of cardiothoracic and vascular anesthesia. 2016;(6):1461-1470
Abstract
OBJECTIVES Comparing different perioperative statin regimens for the prevention of post-coronary artery bypass grafting adverse events. DESIGN A randomized, prospective study. SETTING Cardiothoracic surgical units in a government hospital. PARTICIPANTS The study comprised 94 patients scheduled for elective, isolated on- or off- pump coronary artery bypass grafting. INTERVENTIONS Patients were assigned randomly to 1 of the following 3 treatment groups: group I (80 mg of atorvastatin/day for 2 days preoperatively), group II (40 mg of atorvastatin/day for 5-9 days preoperatively), or group III (80 mg of atorvastatin/day for 5-9 days preoperatively). The same preoperative doses were restarted postoperatively and continued for 1 month. MEASUREMENTS AND MAIN RESULTS Cardiac troponin I, creatine kinase, and C-reactive protein (CRP) levels were assayed preoperatively; at 8, 24, and 48 hours postoperatively; and at discharge. CRP levels at 24 hours (p = 0.045) and 48 hours (p = 0.009) were significantly lower in group III compared with the other 2 groups. However, troponin I levels at 8 hours (p = 0.011) and 48 hours (p = 0.025) after surgery were significantly lower in group II compared with group III. The incidence of postoperative major adverse cardiac and cerebrovascular events was assessed, and there was no significant difference among the 3 groups. CONCLUSION The 3 regimens did not result in any significant difference in outcomes, but only simple trends. The higher-dose regimen resulted in a significant reduction in the CRP level. Thus, more studies are needed to confirm the benefit of higher-dose statins for the protection from post-coronary artery bypass grafting adverse events.
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Consistent Reduction in Periprocedural Myocardial Infarction With Cangrelor as Assessed by Multiple Definitions: Findings From CHAMPION PHOENIX (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition).
Cavender, MA, Bhatt, DL, Stone, GW, White, HD, Steg, PG, Gibson, CM, Hamm, CW, Price, MJ, Leonardi, S, Prats, J, et al
Circulation. 2016;(10):723-33
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BACKGROUND Cangrelor is an intravenous P2Y12 inhibitor approved to reduce periprocedural ischemic events in patients undergoing percutaneous coronary intervention not pretreated with a P2Y12 inhibitor. METHODS A total of 11 145 patients were randomized to cangrelor or clopidogrel in the CHAMPION PHOENIX trial (Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition). We explored the effects of cangrelor on myocardial infarction (MI) using different definitions and performed sensitivity analyses on the primary end point of the trial. RESULTS A total of 462 patients (4.2%) undergoing percutaneous coronary intervention had an MI as defined by the second universal definition. The majority of these MIs (n=433, 93.7%) were type 4a. Treatment with cangrelor reduced the incidence of MI at 48 hours (3.8% versus 4.7%; odds ratio [OR], 0.80; 95% confidence interval [CI], 0.67-0.97; P=0.02). When the Society of Coronary Angiography and Intervention definition of periprocedural MI was applied to potential ischemic events, there were fewer total MIs (n=134); however, the effects of cangrelor on MI remained significant (OR, 0.65; 95% CI, 0.46-0.92; P=0.01). Similar effects were seen in the evaluation of the effects of cangrelor on MIs with peak creatinine kinase-MB ≥10 times the upper limit of normal (OR, 0.64; 95% CI, 0.45-0.91) and those with peak creatinine kinase-MB ≥10 times the upper limit of normal, ischemic symptoms, or ECG changes (OR, 0.63; 95% CI, 0.48-0.84). MIs defined by any of these definitions were associated with increased risk of death at 30 days. Treatment with cangrelor reduced the composite end point of death, MI (Society of Coronary Angiography and Intervention definition), ischemia-driven revascularization, or Academic Research Consortium definite stent thrombosis (1.4% versus 2.1%; OR, 0.69; 95% CI, 0.51-0.92). CONCLUSIONS MI in patients undergoing percutaneous coronary intervention, regardless of definition, remains associated with increased risk of death in the current era. Cangrelor compared with clopidogrel significantly reduces MI regardless of the definition. CLINICAL TRIAL REGISTRATION URL: http://clinicaltrials.gov. Unique identifier: NCT01156571.
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A network meta-analysis comparing perioperative outcomes of interventions aiming to decrease ischemia reperfusion injury during elective liver resection.
Simillis, C, Robertson, FP, Afxentiou, T, Davidson, BR, Gurusamy, KS
Surgery. 2016;(4):1157-69
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OBJECTIVE This study sought to compare the perioperative outcomes of interventions aiming to decrease ischemia-reperfusion (IR) injury during elective liver resection. METHOD A comprehensive literature search was performed to identify randomized controlled trials. A Bayesian network meta-analysis was performed using the Markov chain Monte Carlo method in WinBUGS following the guidelines of the National Institute for Health and Clinical Excellence Decision Support Unit. Odds ratios for binary outcomes and mean differences for continuous outcomes were calculated using a fixed effect model or a random effects model according to model fit. RESULTS Forty-four trials with 2,457 patients having undergone liver resection were included and were divided into 8 classes of interventions aimed at decreasing IR injury and a control group, which was hepatectomy alone. There was no difference between the different interventions in mortality, quantity of blood transfusion, and durations of stay in an intensive therapy unit between any pairwise comparisons. Patients treated with ischemic preconditioning, cardiovascular modulators, and miscellaneous interventions had significantly fewer serious adverse events compared with patients undergoing liver resection alone. Ischemic preconditioning patients had significantly fewer transfusion proportions and shorter operative time than patients treated with steroids. Ischemic preconditioning had significantly less operative blood loss compared with all other interventions, and a lesser duration of hospital stay than hepatectomy alone. Sensitivity analysis showed that the drugs sevoflurane (a volatile anesthetic), verapamil (a calcium channel blocker), and gabexate mesilate (a thrombin inhibitor) produced fewer serious adverse events compared with hepatectomy alone. CONCLUSION Ischemic preconditioning resulted in multiple beneficial clinical endpoints and further RCTs seem to be needed to confirm its clinical benefits.
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Is a Central Venous Catheter Necessary for the Perioperative Management of Esophagectomy? A Prospective Randomized Pilot Study Comparing Two Different Perioperative Regimens.
Saito, K, Nakajima, Y, Kawada, K, Tokairin, Y, Kawano, T
Digestive surgery. 2016;(6):478-87
Abstract
BACKGROUND/AIMS: Our prospective randomized study examined the possibility of perioperative management of esophagectomy without a central venous catheter (CVC). METHODS Forty patients who underwent esophagectomy for esophageal cancer were divided into the total parenteral nutrition (TPN; receiving conventional perioperative management via a CVC) and peripheral parenteral nutrition (PPN; receiving perioperative management without a CVC) groups. Albumin and retinol-binding protein (RBP) levels were used as measurements of the nutritional status. Early postoperative complications and catheter-related complications were also evaluated. RESULTS The actual calories administered per kg of body weight and the albumin and RBP levels did not significantly differ between the groups. Additionally, there was no significant difference in the morbidity of early postoperative complications between the groups. Catheter-related complications were observed in 4 patients in the TPN group (2 catheter infections, 1 case of thrombosis, and 1 case of iatrogenic pneumothorax), and 4 cases of peripheral phlebitis occurred in the PPN group. The incidence of catheter-related complications did not significantly differ between the groups. CONCLUSIONS Perioperative management without a CVC can be safely performed in esophagectomy patients, and the decision to insert a CVC should be made based on the patient's perioperative condition.