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Protective and therapeutic experience of perioperative safety in extremely elderly patients with biliary diseases.
Zhang, Z, Zhao, Y, Lin, F, Liu, L, Zhang, C, Liu, Z, Zhu, M, Wan, B, Deng, H, Yang, H, et al
Medicine. 2021;(21):e26159
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Abstract
To explore the protective and therapeutic measures of improving perioperative safety in extremely elderly patients with biliary diseases, so as to improve the therapeutic efficacy of surgery. A retrospective case–control study of 412 elderly patients with biliary diseases was carried out from July 2013 to July 2019. Seventy eight cases were divided into the high age (HA) group (≥80 years) and 334 into the middle–low age (MLA) group (60–79 years). In the HA compared with MLA group, 1. Preoperative coexisting diseases: the occurrence of coexisting coronary heart disease (CHD), hypertension, chronic bronchitis with emphysema, hypoproteinemia, and anemia were significantly increased; 2. Laboratory examinations: function of liver, kidneys, heart, lungs, and blood coagulation significantly declined; 3. Surgical procedures: open cholecystectomy with transcystic common bile duct (CBD) exploration significantly higher, while laparoscopic cholecystectomy significantly lower; 4. Operative effects: intraoperative blood loss, operation time, postoperative hospital stay, and length of hospitalization significantly increased or prolonged; 5. Postoperative complications: postoperative respiratory failure, pulmonary infection, anemia and electrolyte disorder significantly increased; 6. Therapeutic outcomes: no significant difference in the therapeutic effects. Although the surgical risk was significantly increased, there was no significant difference in the therapeutic efficacy in the HA compared with MLA group, suggesting that surgical treatment in extremely elderly patients with biliary diseases is safe and feasible. The key is to actively treat preoperative coexisting diseases, strictly adhere to surgical indications, reasonably select surgical procedures, precisely perform the operation, closely monitor and control intraoperative emergencies, timely prevent and treat postoperative complications, so as to improve the perioperative safety of extremely elderly patients with biliary diseases.
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Immediate vs. gradual advancement to goal of enteral nutrition after elective abdominal surgery: A multicenter non-inferiority randomized trial.
Zhang, L, Liu, Y, Gao, X, Zhou, D, Zhang, Y, Tian, F, Gao, T, Wang, Y, Chen, Z, Lian, B, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(12):5802-5811
Abstract
BACKGROUND & AIMS The strategy of increasing the postoperative enteral nutrition dose to the target goal has not yet been clarified. This study aimed to determine whether an immediate goal-dose enteral nutrition (IGEN) strategy is non-inferior to a gradual goal-dose enteral nutrition (GGEN) strategy in reducing infections in patients undergoing abdominal surgery involving the organs of the digestive system. METHODS This randomized controlled trial enrolled postoperative patients with nutritional risk screening 2002 scores ≥3 from 11 Chinese hospitals. Energy targets were calculated as 25 kcal/kg and 30 kcal/kg of ideal body weight for women and men, respectively. Patients were randomly assigned 1:1 to IGEN or GGEN group after enteral tolerance was confirmed (30% of the target on day 2). The IGEN group immediately started receiving 100% of the caloric requirements on day 3, while the GGEN group received 40% progressing to 80% of target on day 7. The primary endpoint was the infection rate until discharge, based on the intention-to-treat population. RESULTS A total of 411 patients were enrolled and randomized to the IGEN and GGEN groups, and five patients did not receive the allocated intervention. A total of 406 patients were included in the primary analysis, with 199 and 207 in the IGEN and GGEN groups, respectively. Infection was observed in 17/199 (8.5%) in the IGEN group and 19/207 (9.2%) in the GGEN group, respectively (difference, -0.6%; [95% confidence interval (CI), -6.2%-4.9%]; P = 0.009 for non-inferiority test). There were significantly more gastrointestinal intolerance events with IGEN than with GGEN (58/199 [29.1%] vs. 32/207 [15.5%], P < 0.001). All other secondary endpoints were non-significant. CONCLUSIONS Among postoperative patients at nutritional risk, IGEN was non-inferior to GGEN in regards to infectious complications. IGEN was associated with more gastrointestinal intolerance events. It showed that IGEN cannot be considered to be clinically directive. ClinicalTrials.gov (#NCT03117348).
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Clinical observation of the efficacy of low-molecular-weight heparin calcium in prophylaxis of the deep venous thrombosis following the gynecological tumor surgery.
Wei, N, Qi, Y, Yang, H, Guo, L
Pakistan journal of pharmaceutical sciences. 2018;(6(Special)):2835-2839
Abstract
Present study is conducted to investigate the efficacy and safety of application of low-molecular-weight heparin calcium in the prophylaxis of deep venous thrombosis (DVT) following the laparoscopic surgery for gynecological tumors, so as to provide reference for the selection of anti-coagulant procedure in clinical practice. A total of 180 patients who underwent the laparoscopic surgery for the gynecological tumors in this hospital between January 2015 and December 2017 were enrolled in this study, and according to the anti-coagulant procedure, they were divided into two groups, i.e. the control group and the observation group, with 90 patients in each group. In the control group, 90 patients were free from the anti-coagulant agent or drugs affecting the coagulant functions, while those in the observation group received the subcutaneous injection of low-molecular-weight heparin calcium for consecutive 5 days. Then we compared the serological indicators, prothrombin time (PT), cross-section diameter of the lower limb, hemodynamic indicator and the incidence rate of complications. Following postoperative 5 days, the levels of fibrinogen and D-dimer in the observation group were (2.66±0.72) g/L and (0.61±0.17) μg/mL, significantly lower than those in the control group, and the differences had statistical significance (t=4.667, P=0.019; t=3.967, P= 0.029). At 3 d and 5 d after operation, PTs in the observation group were (13.74±3.92) s and (13.84±3.13) s, also superior to the control group (t=3.031, P=0.042; t=3.553, P =0.034). In the observation group, the cross-section diameter of lower limb and blood flow rate were (20.22±3.51) cm and (0.93±0.17) m/s, respectively, which were better than the control group, and the difference had statistical significance (t=4.412, P=0.021; t =4.724, P=0.019). In the observation group, the incidence rate of complications was only 3.33%, significantly lower than 10.00% in the control group (c2 =6.158, P=0.004). The application of the low-molecular-weight heparin calcium for anti-coagulation in the prophylaxis of the DVT following the laparoscopic surgery of gynecological tumor can better ameliorate the hemodynamics of patients, and prevent the formation of DVT.
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Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: The FAIRY Randomized Clinical Trial.
Kim, YW, Bae, JM, Park, YK, Yang, HK, Yu, W, Yook, JH, Noh, SH, Han, M, Ryu, KW, Sohn, TS, et al
JAMA. 2017;(20):2097-2104
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Abstract
IMPORTANCE Acute isovolemic anemia occurs when blood loss is replaced with fluid. It is often observed after surgery and negatively influences short-term and long-term outcomes. OBJECTIVE To evaluate the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy. DESIGN, SETTING, AND PARTICIPANTS The FAIRY trial was a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between February 4, 2013, and December 15, 2015, in 7 centers across the Republic of Korea. Patients with a serum hemoglobin level of 7 g/dL to less than 10 g/dL at 5 to 7 days following radical gastrectomy were included. INTERVENTIONS Patients were randomized to receive a 1-time or 2-time injection of 500 mg or 1000 mg of ferric carboxymaltose according to body weight (ferric carboxymaltose group, 228 patients) or normal saline (placebo group, 226 patients). MAIN OUTCOMES AND MEASURES The primary end point was the number of hemoglobin responders, defined as a hemoglobin increase of 2 g/dL or more from baseline, a hemoglobin level of 11 g/dL or more, or both at week 12. Secondary end points included changes in hemoglobin, ferritin, and transferrin saturation levels over time, percentage of patients requiring alternative anemia management (oral iron, transfusion, or both), and quality of life at weeks 3 and 12. RESULTS Among 454 patients who were randomized (mean age, 61.1 years; women, 54.8%; mean baseline hemoglobin level, 9.1 g/dL), 96.3% completed the trial. At week 12, the number of hemoglobin responders was significantly greater for ferric carboxymaltose vs placebo (92.2% [200 patients] for the ferric carboxymaltose group vs 54.0% [115 patients] for the placebo group; absolute difference, 38.2% [95% CI, 33.6%-42.8%]; P = .001). Compared with the placebo group, patients in the ferric carboxymaltose group experienced significantly greater improvements in serum ferritin level (week 12: 233.3 ng/mL for the ferric carboxymaltose group vs 53.4 ng/mL for the placebo group; absolute difference, 179.9 ng/mL [95% CI, 150.2-209.5]; P = .001) and transferrin saturation level (week 12: 35.0% for the ferric carboxymaltose group vs 19.3% for the placebo group; absolute difference, 15.7% [95% CI, 13.1%-18.3%]; P = .001); but there were no significant differences in quality of life. Patients in the ferric carboxymaltose group required less alternative anemia management than patients in the placebo group (1.4% for the ferric carboxymaltose group vs 6.9% for the placebo group; absolute difference, 5.5% [95% CI, 3.3%-7.6%]; P = .006). The total rate of adverse events was higher in the ferric carboxymaltose group (15 patients [6.8%], including injection site reactions [5 patients] and urticaria [5 patients]) than the placebo group (1 patient [0.4%]), but no severe adverse events were reported in either group. CONCLUSION AND RELEVANCE Among adults with isovolemic anemia following radical gastrectomy, the use of ferric carboxymaltose compared with placebo was more likely to result in improved hemoglobin response at 12 weeks. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01725789.