Safety and Efficacy Evaluation of Antithrombotic Therapy with Rivaroxaban and Clopidogrel After PCI in Chinese Patients.

OBJECTIVE: To investigate the efficacy and safety of the antithrombotic therapy using the oral anticoagulant rivaroxaban and clopidogrel in Chinese patients with acute coronary syndrome complicated with atrial fibrillation after percutaneous coronary intervention. METHODS: A total of 100 patients were selected. Patients were randomly divided into two groups: the treatment group (rivaroxaban group) received a therapy of rivaroxaban and clopidogrel. The control group (warfarin group) receivied a combined treatment of warfarin, clopidogrel, and aspirin. The primary outcome endpoint was evaluated based on the adverse cardiac and cerebrovascular events within 12 months. RESULTS: A total of 8 (8.00%) main adverse cardiac and cerebrovascular events occurred during the 12 months of follow-up, including 5 (9.80%) in the warfarin group and 3 (6.10%) in the rivaroxaban group. The risk of having main adverse cardiac and cerebrovascular events in the two groups was comparable (P = 0.479). A total of 9 patients (9.00%) were found to have bleeding events, among which 8 patients (15.7%) were in the warfarin group, whereas only 1 patient (2.00%) was in the rivaroxaban group. Therefore, the risk of bleeding in the warfarin group was significantly higher than that in the rivaroxaban group (P = 0.047). CONCLUSIONS: In Chinese patients with acute coronary syndrome complicated with atrial fibrillation, the efficacy of the dual therapy of oral anticoagulant rivaroxaban plus clopidogrel after percutaneous coronary intervention was similar to that of the traditional triple therapy combined with warfarin, aspirin and clopidogrel, but it has a better safety property, which has potential to widely apply to antithrombotic therapy after PCI.

The Most Current Algorithms for the Treatment and Prevention of Hypertrophic Scars and Keloids: A 2020 Update of the Algorithms Published 10 Years Ago.

BACKGROUND: In 2010, this Journal published my comprehensive review of the literature on hypertrophic scars and keloids. In that article, I presented evidence-based algorithms for the prevention and treatment of these refractory pathologic scars. In the ensuing decade, substantial progress has been made in the field, including many new randomized controlled trials. To reflect this, I have updated my review. METHODS: All studies were evaluated for methodologic quality. Baseline characteristics of patients were extracted along with the interventions and their outcomes. Systematic reviews, meta-analyses, and comprehensive reviews were included if available. RESULTS: Risk factors that promote hypertrophic scar and keloid growth include local factors (tension on the wound/scar), systemic factors (e.g., hypertension), genetic factors (e.g., single-nucleotide polymorphisms), and lifestyle factors. Treatment of hypertrophic scars depends on scar contracture severity: if severe, surgery is the first choice. If not, conservative therapies are indicated. Keloid treatment depends on whether they are small and single or large and multiple. Small and single keloids can be treated radically by surgery with adjuvant therapy (e.g., radiotherapy) or multimodal conservative therapy. For large and multiple keloids, volume- and number-reducing surgery is a choice. Regardless of the treatment(s), patients should be followed up over the long term. Conservative therapies, including gel sheets, tape fixation, topical and injected external agents, oral agents, and makeup therapy, should be administered on a case-by-case basis. CONCLUSIONS: Randomized controlled trials on pathologic scar management have increased markedly over the past decade. Although these studies suffer from various limitations, they have greatly improved hypertrophic scar and keloid management. Future high-quality trials are likely to improve the current hypertrophic scar and keloid treatment algorithms further.

Postoperative Chemoradiotherapy With Capecitabine and Oxaliplatin vs Capecitabine for Stage II to III Rectal Cancer: A Randomized Clinical Trial.

Importance: Several studies have explored the efficacy and toxic effects of concurrent 5-fluorouracil (5-FU)- or capecitabine-based chemoradiotherapy (CRT) with or without oxaliplatin in the neoadjuvant setting. Addition of oxaliplatin to 5-FU or capecitabine elicited similar outcomes but with significantly increased toxic effects; however, there is a need for randomized clinical trials comparing 2 CRT regimens for patients receiving CRT in the adjuvant setting. Objective: To explore the efficacy and toxic effects of oxaliplatin combined with postoperative concurrent capecitabine and radiotherapy (RT) for pathological stage II and III rectal cancer. Design, Setting, and Participants: This multicenter randomized clinical trial enrolled patients from 7 centers in China between April 1, 2008, and December 30, 2015. Patients with pathologically confirmed stage II and III rectal cancer were randomized (1:1) to receive concurrent CRT with capecitabine or capecitabine plus oxaliplatin. Analysis was conducted from December 31, 2019, to March 15, 2020. Interventions: RT comprised 45 to 50 Gy in 25 fractions of 1.8 to 2.0 Gy over 5 weeks. In the capecitabine with RT group, concurrent chemotherapy included 2 cycles of capecitabine (1600 mg/m2) on days 1 to 14 and 22 to 35. The capecitabine and oxaliplatin with RT group received identical postoperative RT to that in the capecitabine with RT group combined with capecitabine (1300 mg/m2) on days 1 to 14 and 22 to 35 and a 2-hour infusion of oxaliplatin (60 mg/m2) on weeks 1, 2, 4, and 5. Patients in both groups received adjuvant chemotherapy (capecitabine or fluorouracil and oxaliplatin) after CRT. Main Outcomes and Measures: The primary end point was 3-year disease-free survival (DFS). Results: A total of 589 patients (median [IQR] age, 55 [47-52] years; 375 [63.7%] men and 214 [36.3%] women) were enrolled, including 294 patients randomized to the capecitabine with RT group and 295 patients randomized to the capecitabine and oxaliplatin with RT group. Median (IQR) follow-up was 68 (45-96) months. Most patients had stage III disease (574 patients [75.9%]). Three-year DFS was 76.3% for the capecitabine with RT group and 74.1% for the capecitabine and oxaliplatin with RT group, and 5-year DFS was 72.0% for the capecitabine with RT group and 71.1% for the capecitabine and oxaliplatin with RT group (hazard ratio [HR], 1.07; 95% CI, 0.79-1.44; P = .68). There was no significant difference between groups in overall survival (HR, 0.93; 95% CI, 0.64-1.34; P = .70) or local recurrence (HR, 0.61; 95% CI, 0.31-1.22; P = .16). More grade 3 and 4 acute toxic effects were observed in the capecitabine and oxaliplatin with RT group than in the capecitabine with RT group (114 patients [38.6%] vs 84 patients [28.6%]; P = .01). Conclusions and Relevance: This randomized clinical trial found that addition of oxaliplatin to capecitabine-based postoperative CRT did not improve the efficacy of treatment but increased the risk of severe acute toxic effects. This finding highlights the basic role of postoperative capecitabine with RT for patients with locally advanced rectal cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT00714077.

Postoperative arginine-enriched immune modulating nutrition: Long-term survival results from a randomised clinical trial in patients with oesophagogastric and pancreaticobiliary cancer.

BACKGROUND & AIMS: Immune modulating nutrition (IMN) has been shown to reduce postoperative infectious complications and length of stay in patients with gastrointestinal cancer. Two studies of IMN in patients undergoing surgery for head and neck cancer also suggested that this treatment might improve long-term survival and progression-free survival. In the present study, we analysed follow-up data from our previous randomised controlled trial of IMN, in patients undergoing surgery for oesophagogastric and pancreaticobiliary cancer, in order to evaluate the long-term impact on survival of postoperative IMN versus an isocaloric, isonitrogenous control feed. METHODS: This study included patients undergoing surgery for cancers of the pancreas, oesophagus and stomach, who had been randomised in a double-blind manner to receive postoperative jejunostomy feeding with IMN (Stresson, Nutricia Ltd.) or an isonitrogenous, isocaloric feed (Nutrison High Protein, Nutricia) for 10-15 days. The primary outcome was long-term overall survival. RESULTS: There was complete follow-up for all 108 patients, with 54 patients randomised to each group. There were no statistically significant differences between groups by demographics [(age, p = 0.63), sex (p = 0.49) or site of cancer (p = 0.25)]. 30-day mortality was 11.1% in both groups. Mortality in the intervention group was 13%, 31.5%, 70.4%, 85.2%, 88.9%, and 96.3% at 90 days, and 1, 5, 10, 15 and 20 years respectively. Corresponding mortality in the control group was 14.8%, 35.2%, 68.6%, 79.6%, 85.2% and 98.1% (p > 0.05 for all comparisons). CONCLUSION: Early postoperative feeding with arginine-enriched IMN had no impact on long-term survival in patients undergoing surgery for oesophagogastric and pancreaticobiliary cancer.

Persistent Postthyroidectomy Hypoparathyroidism in the Netherlands.

Importance: Hypoparathyroidism is one of the most common complications after total or completion thyroidectomy. The reported incidence rate of hypoparathyroidism in the literature is highly variable. Data that provide a better understanding of the magnitude of this postoperative complication are warranted and can provide a stepping stone for further collaborations that aim to reduce complication rates and establish uniform treatment protocols. Objective: To evaluate the incidence of postoperative, persistent hypoparathyroidism after total or completion thyroidectomy in patients who were referred to university hospital centers and assess the association of different definitions with the incidence of hypoparathyroidism. Design, Setting, and Participants: This retrospective multicenter cohort study conducted throughout 2016 in 7 Dutch university hospital centers included 200 patients who were undergoing a total or completion thyroidectomy. Data analysis was conducted in January 2021. Main Outcomes and Measures: We report on the incidence of persistent hypoparathyroidism, defined as the need for active vitamin D with or without calcium supplementation longer than 1 year after surgery. Results: A total of 200 patients (143 women [71.5%]; mean [IQR] age, 49.0 [37.0-62.0] years) were included and 30 patients (15.0%) developed persistent hypoparathyroidism. The incidence of persistent hypoparathyroidism varied between 14.5% (calcium and active vitamin D 1 year postsurgery) to 28.5% (calcium and/or active vitamin D 6 months postsurgery) depending on the definition used. Conclusions and Relevance: In this cohort study, the risk of persistent hypoparathyroidism after total or completion thyroidectomy was 15% in patients who were referred to university hospital centers. The high rate of persistent hypoparathyroidism warrants efforts to reduce this complication rate. There is discrepancy in the definition and treatment of persistent hypoparathyroidism, and use of uniform evidence-based treatment guidelines enables comparison of interventions.

Assessment of Body Composition as an Indicator of Early Peripheral Parenteral Nutrition Therapy in Patients Undergoing Colorectal Cancer Surgery in an Enhanced Recovery Program.

BACKGROUND: A poor body composition (BC) has been identified as a risk factor for patients with colorectal cancer (CRC). This study was performed to assess the effect of early peripheral parenteral nutrition (PPN) on BC in patients undergoing CCR surgery within an enhanced recovery program. METHODS: Patients with normal nutritional status were prospectively included between October 2016 and September 2019, randomized into two groups (PPN with periOlimel N4-E versus conventional fluid therapy) and subsequently classified according to their preoperative CT scan into high- or low-risk BC groups. Postoperative complications and length of hospital stay (LOS) were assessed. RESULTS: Of the 156 patients analyzed, 88 patients (56.4%) were classified as having high-risk BC according to CT measurements. PPN led to a 15.4% reduction in postoperative complications in high-risk vs. 1.7% in low-risk BC patients. In the multivariate analysis, high-risk BC was related to an OR (95% CI) of 2 (p = 0.044) of presenting complications and of 1.9 (p = 0.066) for major complications, and was associated with an increase in LOS of 3.6 days (p = 0.039). CONCLUSIONS: The measurement of patients' BC can allow for the identification of target patients where PPN has been proven to be an effective tool to improve postoperative outcomes.

Digestion-Specific Acupuncture Effect on Feeding Intolerance in Critically Ill Post-Operative Oral and Hypopharyngeal Cancer Patients: A Single-Blind Randomized Control Trial.

Malnourishment is prevalent in patients suffering from head and neck cancer. The postoperative period is crucial in terms of nutritional support, especially after composite resection and reconstruction surgery. These patients present with a number of risk factors that aggravate feeding intolerance, including postoperative status, prolonged immobility, decreased head elevation, mechanical ventilation, and applied sedative agents. Routine management protocols for feeding intolerance include prokinetic drug use and post-pyloric tube insertion, which could be both limited and accompanied by detrimental adverse events. This single-blind clinical trial aimed to investigate the effects of acupuncture in postoperative feeding intolerance in critically ill oral and hypopharyngeal cancer patients. Twenty-eight patients were randomized into two groups: Intervention group and Control group. Interventions were administered daily over three consecutive postoperative days. The primary outcome revealed that the intervention group reached 70% and 80% of target energy expenditure (EE) significantly earlier than the control group (4.00 ± 1.22 versus 6.69 ± 3.50 days, p = 0.012), accompanied by higher total calorie intake within the first postoperative week (10263.62 ± 1086.11 kcals versus 8384.69 ± 2120.05 kcals, p = 0.004). Furthermore, the intervention group also needed less of the prokinetic drug (Metoclopramide, 20.77 ± 48.73 mg versus 68.46 ± 66.56 mg, p = 0.010). In conclusion, digestion-specific acupuncture facilitated reduced postoperative feeding intolerance in oral and hypopharyngeal cancer patients.

Impact of STIMUlant and osmotic LAXatives (STIMULAX trial) on gastrointestinal recovery after colorectal surgery: randomized clinical trial.

BACKGROUND: Recovery of gastrointestinal (GI) function is often delayed after colorectal surgery. Enhanced recovery protocols (ERPs) recommend routine laxative use, but evidence of benefit is unclear. This study aimed to investigate whether the addition of multimodal laxatives to an ERP improves return of GI function in patients undergoing colorectal surgery. METHODS: This was a single-centre, parallel, open-label RCT. All adult patients undergoing elective colorectal resection or having stoma formation or reversal at the Royal Adelaide Hospital between August 2018 and May 2020 were recruited into the study. The STIMULAX group received oral Coloxyl® with senna and macrogol, with a sodium phosphate enema in addition for right-sided operations. The control group received standard ERP postoperative care. The primary outcome was GI-2, a validated composite measure defined as the interval from surgery until first passage of stool and tolerance of solid intake for 24 h in the absence of vomiting. Secondary outcomes were the incidence of prolonged postoperative ileus (POI), duration of hospital stay, and postoperative complications. The analysis was performed on an intention-to-treat basis. RESULTS: Of a total of 170 participants, 85 were randomized to each group. Median GI-2 was 1 day shorter in the STIMULAX compared with the control group (median 2 (i.q.r. 1.5-4) versus 3 (2-5.5) days; 95 per cent c.i. -1 to 0 days; P = 0.029). The incidence of prolonged POI was lower in the STIMULAX group (22 versus 38 per cent; relative risk reduction 42 per cent; P = 0.030). There was no difference in duration of hospital day or 30-day postoperative complications (including anastomotic leak) between the STIMULAX and control groups. CONCLUSION: Routine postoperative use of multimodal laxatives after elective colorectal surgery results in earlier recovery of gastrointestinal function and reduces the incidence of prolonged POI. Registration number: ACTRN12618001261202 (www.anzctr.org.au).

Clinical, randomized, double blind clinical trial to study the effect of parenteral supplementation with fish oil emulsion in the nutritional support in esophagectomized patients.

INTRODUCTION: Esophagectomy is a major surgery with a high degree of catabolic and post-surgical inflammatory response accompanied by high morbidity and significant mortality. Post-surgical nutritional support via enteral administration of ω-3 fatty acids has been seen to be effective although its bad tolerance. There are few clinical trials with parenteral ω-3 fatty acids in these patients. We propose to investigate the effect of combining a parenteral fish oil lipid emulsion with the standard enteral nutrition (EN) support. MATERIALS AND METHODS: Prospective, single-center, randomized, double-blind study in esophagectomized patients, and treated after surgery with parenteral lipid emulsions of ω-3 fatty acids or a mixture of ω-6 long-chain triglycerides/short-chain triglycerides 50%. These emulsions will be added to the standard nutritional support in continuous infusion until 5 days of treatment have been completed. Patients will be randomized 1:1:1 in Group A receiving 0.4 g/kg/d of fish-oil lipid emulsion and 0.4 g/kg/d of a lipid emulsion mixture of ω-6 long-chain fatty acids (LCT) plus medium-chain fatty acids (MCT) (total dose of 0.8 g/kg/d of lipid emulsion); Group B receiving 0.8 g/kg/d of fish oil lipid emulsion and Group C receiving 0.8 g/kg/d of LCT/MCT emulsion.The main objective is to determine whether 5 days administration of intravenous ω-3 fatty acid lipid emulsion is effective in normalizing interleukin-6 levels compared with LCT/MCT emulsions, and whether a 0.8 g/kg/d dose is more effective than 0.4 g/kg/d. Secondary outcomes include other inflammatory markers such as C-reactive protein, tumor necrosis factor alpha and interleukin-10, and parameters of morbidity, safety, nutrition and mortality.Samples will be collected at the time when surgery is indicated and on days 0, 1, 3, 5 and 21 to determine inflammatory, nutritional, hepatic and safety parameters. In addition, clinical follow-up will be continued throughout the hospital admision and up to 1 year after surgery. DISCUSSION: Studies of ω-3 fatty acids administered parenterally in esophagectomized patients are scarce. This study proposes to investigate the effect of combining fish-oil lipid emulsions administered parenterally with EN support. Potential benefits include fast incorporation of lipids to the cellular membranes and to the inflammatory cascade, and the use of only 1 pharmaconutrient. TRIAL REGISTRATION: FAR-NP-2017-01 EudraCT number: 2016-004978-17.https://reec.aemps.es/reec/public/detail.html searching the EudraCT number. VERSION IDENTIFIER: Version 2, 08/06/2017.

Intravenous iron supplementation after liver surgery: Impact on anemia, iron, and hepcidin levels-a randomized controlled trial.

BACKGROUND: Anemia is a recognized risk factor for perioperative related morbidity and mortality and is frequently reported in liver surgeries with an estimated incidence of 32%. We aim to assess the impact of intravenous iron administration in the immediate postoperative period on anemia and iron status as well as to determine the kinetics of hepcidin after liver surgery. METHODS: The HepciFer trial, a randomized controlled trial, included 50 patients undergoing liver surgery. In accordance with the randomization process, patients received either ferric carboxymaltose (15 mg/kg, maximum 1 g) or placebo 4 hours after surgery. RESULTS: The mean hemoglobin level, 7 days after surgery, did not differ significantly between the intervention and control group (11.1 ± 1.8 g/dL and 10.4 ± 1.6 g/dL, respectively) with a mean difference of +0.7 g/dL ([95% confidence interval, -0.3 to +1.7], P = .173). Within patients receiving intravenous iron supplementation, none presented biological signs of functional iron deficiency. Hepcidin levels remained significantly higher during the observation period in the intervention group. Inflammatory biomarkers, red blood cells transfusion rate and hospital duration of stay were similar between groups. CONCLUSION: Intravenous ferric carboxymaltose administration did not result in a significant increase of hemoglobin levels 7 days after surgery. However, this study suggests that intravenous iron supplementation in the immediate postoperative settings prevents functional iron deficiency. Intravenous iron supplementation overcame the hepcidin-mediated blockade of iron absorption and should be considered as the preferred route of administration in the postoperative period.

Effects of Baduanjin on postoperative rehabilitation of patients with breast cancer: A protocol for systematic review and meta-analysis.

BACKGROUND: Baduanjin, as an ancient Chinese exercise, is beneficial to both physical and mental health. Moreover, researchers discovered that Baduanjin has effects on the recovery of postoperative breast cancer patients. Yet, nobody focused on the systematic review, which can provide convincing evidence to verify the effect of Baduanjin in breast cancer patients. Therefore, our study will conduct a systematic review to fill in the blank, besides we will offer new evidence for clinical workers. METHODS: PubMed, Embase.com, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang, and SinoMed will be used for literature search, retrieve time is up to June 1, 2021. We will include randomized controlled trials that evaluate the effects of Baduanjin on postoperative rehabilitation for breast cancer patients. Two independent researchers will perform study selection and data extraction. The risk of bias will be assessed by the Cochrane bias assessment tool. We will use funnel plot and Egger test to evaluate publication bias. Stata 13.0, as a necessary software, will be used to perform statistical analysis. Also, we will utilize subgroup analyses and sensitivity analyses to explore the sources of heterogeneity. RESULTS: The results of this study will be published in a peer-reviewed journal. CONCLUSION: Evidence that adequately assesses the effect of Baduanjin in the recovery of breast cancer patients will be confirmed through this systematic review. Our study will offer a guideline for clinical workers, besides we will supply a new way for the rehabilitation of breast cancer patients.

Inability of Radioiodine Remnant Ablation to Improve Postoperative Outcome in Adult Patients with Low-Risk Papillary Thyroid Carcinoma.

OBJECTIVE: To determine whether radioiodine remnant ablation (RRA) reduces cause-specific mortality (CSM) or tumor recurrence (TR) rate after bilateral lobar resection (BLR). PATIENTS AND METHODS: There were 2952 low-risk adult papillary thyroid cancer (LRAPTC) patients (with MACIS scores <6) who underwent potentially curative BLR during 1955-2014. During 1955-1974, 1975-1994, and 1995-2014, RRA was administered in 3%, 49%, and 28%. Statistical analyses were performed using SAS software. RESULTS: During 1955-1974, the 20-year CSM and TR rates after BLR alone were 1.0% and 6.8%; rates after BLR+RRA were 0% (P=.63) and 5.9% (P=.82). During 1975-1994, post-BLR 20-year rates for CSM and TR were 0.3% and 7.5%; after BLR+RRA, rates were higher at 0.9% (P=.31) and 12.8% (P=.01). When TR rates were examined separately for 448 node-negative and 317 node-positive patients, differences were nonsignificant. In 1995-2014, post-BLR 20-year CSM and TR rates were 0% and 9.2%; rates after BLR+RRA were higher at 1.4% (P=.19) and 21.0% (P<.001). In 890 pN0 cases, 15-year locoregional recurrence rates were 3.4% after BLR and 3.7% after BLR+RRA (P=.99). In 740 pN1 patients, 15-year locoregional recurrence rates were 10% higher after BLR+RRA compared with BLR alone (P=.01). However, this difference became nonsignificant when stratified by numbers of metastatic nodes. CONCLUSION: RRA administered to LRAPTC patients during 1955-2014 did not reduce either the CSM or TR rate. We would therefore not recommend RRA in LRAPTC patients undergoing BLR with curative intent.

Acupuncture and herbal medicine for postoperative care following anterior cruciate ligament reconstruction: A protocol for systematic review and meta-analysis.

BACKGROUND: Anterior cruciate ligament reconstruction (ACLR) is the primary treatment for patients with anterior cruciate ligament (ACL) injury. Successful postoperative rehabilitation is imperative for their recovery. This protocol details the methods that will be used to systematically analyze the efficacy of acupuncture and herbal medicine for postoperative care following ACLR. METHODS AND ANALYSIS: Randomized controlled trials will be searched in the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, MEDLINE/PubMed, Chinese National Knowledge Infrastructure, Japan Medical Abstracts Society, and 7 Korean databases (Oriental Medicine Advanced Searching Integrated System, Korean National Assembly Digital Library, Korean Association of Medical Journal Editors, Korean Studies Information Service System, Korean Traditional Knowledge Portal, National Digital Science Library, and Database Periodical Information Academic). The risk of bias will be assessed using the Cochrane assessment tool of risk of bias. The studies that are selected after checking for eligibility will be quantitatively analyzed as a meta-analysis. The primary outcome will be the scores of pain scales, and the secondary outcomes will be the range of motion of the knee, severity of the swelling, and parameters about the knee joint function. ETHICS AND DISSEMINATION: Ethical approval is not required for this protocol because it does not include patient data. The findings of this review will be disseminated through peer-reviewed publications or conference presentations. REGISTRATION NUMBER: DOI 10.17605/OSF.IO/ZY2W8 (https://osf.io/zy2w8).

Efectos del cuidado espiritual en la ansiedad situacional de pacientes quirúrgicos / Effects of Spiritual Care on Situational Anxiety of Surgical Patients

Introducción: Las personas con tratamiento quirúrgico presentan ansiedad, lo cual impide llegar al periodo operatorio en óptimas condiciones. El cuidado espiritual puede resultar efectivo en momentos como este. Objetivo: Evaluar el efecto del cuidado espiritual en el nivel de ansiedad situacional en pacientes quirúrgicos. Métodos: Investigación cuantitativa, preexperimental con pretest postest, en el Hospital Regional de Ayacucho, Perú, durante marzo a mayo de 2016. Población constituida por 123 pacientes quirúrgicos, entre los que se seleccionaron 30 entre 24 y 57 años, con ansiedad y dispuestos a participar en la investigación. La ansiedad se midió con el Test de Zung, las necesidades espirituales con un cuestionario validado por expertos y pilotaje con alfa de Cronbach > 0,75. Para los ejes temáticos y metodológicos de la intervención (cuidados espirituales) se revisó bibliografía sobre el tema, tuvieron en cuenta las necesidades de cuidados y niveles de ansiedad identificada. Se procesó la información con frecuencias absolutas, porcentajes, media, desviación típica, valor mínimo y máximo. Para contrastar hipótesis se utilizó la Prueba no paramétrica de rangos con signo de Wilcoxon. Para la relación entre necesidad de cuidado espiritual y evolución del nivel de ansiedad se utilizó Chi-cuadrada de Pearson (X2), con probabilidad de error del 5 por ciento. Resultados: El nivel de ansiedad situacional previo a la aplicación del cuidado espiritual fue de marcada a severa en 86,66 por ciento, aplicado el cuidado espiritual estuvo ausente en el 96,66 por ciento. Conclusión: La intervención con cuidados espirituales aplicada resultó efectiva en la disminución del nivel de ansiedad situacional en pacientes quirúrgicos estudiados(AU)

Introduction: People who should undergo surgical treatment present anxiety, which keeps them from reaching the operative period in optimal conditions. Spiritual care can be effective at times like this. Objective: To assess the effect of spiritual care on the level of situational anxiety in surgical patients. Methods: Quantitative pre-experimental research with pre- and post-test carried out in the Regional Hospital of Ayacucho, Peru, during March to May 2016. The population was made up of 123 surgical patients, of which 30 aged 24-57, with anxiety and willing to participate in the study were chosen. Anxiety was measured with the Zung test; spiritual needs, with a questionnaire validated by experts; and piloting, with Cronbach's alpha > 0.75. For the thematic and methodological axes of the intervention (spiritual care), a bibliography on the subject was reviewed, taking into account the care needs and levels of anxiety identified. The information was processed with absolute frequencies, percentages, mean, standard deviation, minimum and maximum values. The Wilcoxon signed rank test was used to test hypotheses. Pearson's chi-square (X2) was used for the relationship between need for spiritual care and evolution of anxiety level, with a probability of error of 5 percent. Results: The level of situational anxiety prior to the application of spiritual care was remarkable to severe in 86.66%; applied spiritual care was absent in 96.66 percent.. Conclusion: The intervention with spiritual care applied was effective in reducing the level of situational anxiety in the surgical patients studied.(AU)

Effects of acupuncture on postoperative recovery and extubation time: A protocol for systematic review and meta analysis.

BACKGROUND: This systematic review protocol aims to provide evidence of the efficacy and safety of acupuncture on postoperative recovery and extubation time. METHODS: The following 11 electronic databases will be searched from inception: The Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, AMED, CINAHL, 1 Chinese database (CNKI), and 5 Korean databases (OASIS, DBpia, RISS, KISS, NDSL). Only randomized controlled trials of acupuncture treatment for postoperative recovery after surgery will be included for review. The selection of the studies, data extraction, and management will be performed independently by 3 researchers. Methodological quality, including the risk of bias, will be assessed using the Cochrane risk of bias assessment tool. RESULTS AND CONCLUSIONS: Our systematic review will provide evidence of the efficacy of acupuncture on postoperative recovery and extubation time. This evidence will provide useful information to practitioners and patients in the field of surgery and complementary medicine. PROSPERO REGISTRATION NUMBER: 2020 CRD42020168411.

Intensive calcium monitoring improves outcomes on hungry bone syndrome in hyperparathyroidism.

Objectives. Hungry bone syndrome (HBS) is a severe and underdiagnosed complication of parathyroidectomy in the treatment of primary hyperparathyroidism (PHP) and secondary hyper-parathyroidism to chronic kidney disease (SHP-CKD).Methods. A longitudinal study was conducted to compare the postoperative outcomes of patients who developed HBS in two different time frames: before and after implementing a protocol with an intensive electrolytic monitoring and an algorithm regarding electrolytic supplementation.Results. Overall, 77 parathyroidectomies were included. In PHP, a protocol implementation led to an increased admission of patients in the Intermediate Care Unit for intensive electrolytic monitoring (p<0.001) and an increased rate of oral calcium replacement during hospital stay (p=0.013) compared to pre-protocol era. In SHP-CKD, duration of intravenous calcium replacement was reduced (p=0.010). The prevalence of HBS (9.8% in PHP and 58.3% in SHP-CKD) was similar between the two periods, although its diagnosis had an increased trend in PHP since the protocol implementation. None of the diagnosis of HBS was established due to hypocalcemic symptoms in the post-protocol era (contrary to pre-protocol period, p=0.021). Both hypocalcemia length and duration of surgical ward hospitalization were reduced (p=0.047 and p=0.042, respectively).Conclusions. An improved assessment of hyperparathyroidism and a decrease in HBS severity were noted in the post-protocol era. We strongly recommend the implementation of a standardized protocol with an intensive phosphocalcium monitoring in the high-risk patients who undergo parathyroidectomy due to hyperparathyroidism as it improves the health care and management of HBS.

The effect of atorvastatin on recurrence of chronic subdural hematoma after novel YL-1 puncture needle surgery.

OBJECTIVE: Chronic subdural hematoma (CSDH) is a common neurological disorder with a high recurrence rate. This study investigates the effect that atorvastatin has when used as a postoperative adjuvant therapy on the prevention of CSDH recurrence after YL-1 puncture needle surgery. PATIENTS AND METHODS: A retrospective analysis of 516 CSDH patients who underwent YL-1 puncture needle surgery was undertaken. Baseline characteristics including sex, age, history of injury, past medical histories (anticoagulation, liver dysfunction, heart diseases, malignant tumors, diabetes, hemodialysis, and chronic alcoholism), and computed tomography (CT) or magnetic resonance imaging (MRI) diagnostic indicators (bilateral, mixed density or signal, maximum hematoma width, and brain atrophy) were recorded. Differences in recurrence rates were compared between two groups: one with atorvastatin after surgery and one without. RESULTS: 516 patients (429 men and 87 women), aged 14-98 years (mean age, 67.09 ± 11.74 years) were included in the study. YL-1 puncture needle surgery was performed 610 times. 94 patients had bilateral surgery, totaling 184 procedures. 301 patients with 360 procedures were treated with atorvastatin after surgery, of which 25 had recurrent CSDH; recurrence rate: 7.0 % (25/360). 215 patients with 250 procedures had surgery without subsequent atorvastatin, of which 14 had recurrent CSDH; recurrence rate: 5.6 % (14/250). Univariate analysis indicated no statistically significant difference in recurrence rates between groups (P > 0.05). Baseline characteristics of the two groups (age, sex, history of injury, past medical histories, CT or MRI diagnostic indicators) also showed no statistical difference (all P > 0.05). CONCLUSIONS: YL-1 puncture needle surgery with irrigation and closed-system drainage is an effective surgical treatment for CSDH. Atorvastatin has no statistically significant effect on the prevention of CSDH recurrence after surgery.

Effectiveness of acupuncture for the recovery of gastrointestinal function of patients with gastric cancer in the postoperative period: A protocol for systematic review and meta-analysis.

BACKGROUND: Gastric cancer (GC) is the most common malignant tumors in the world and surgical resection remains the primary treatment for it. Postoperative patients often suffer from gastrointestinal dysfunction as the most common side effects of surgery for GC patients. Acupuncture has a regulatory effect on gastrointestinal function. We conducted this study to assess the effectiveness of acupuncture on the restoration of gastrointestinal function of postoperative patients with GC. METHODS: Seven electronic databases will be searched from inception to November 2020 to identify any relevant study: Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), China National Knowledge Infrastructure (CNKI), Wanfang Database, Chinese Biomedical Literature Database (CBM), and Chinese Scientific Journal Database (VIP database). No restriction on time and language. The primary outcome measure will be the Time to First Flatus and secondary outcome measures include the time of first defecation and the quality of life (QOL) and the number of patients with abdominal distention. We will use EndNote V.9.1 to screen the eligible literature and the I2 statistic to assess heterogeneity in the included studies. The meta-analysis will be conducted using the Review Manager (RevMan) software (V.5.3). RESULTS: Our study aims to systematically assess whether the pooled effects of currently available trials prove effects of acupuncture in improving gastrointestinal function of patients with GC in the postoperative period. CONCLUSION: This study will conduct an evaluation about the efficacy of acupuncture for the recovery of gastrointestinal function of patients with GC in the postoperative period, making up for the lack of relevant clinical evidence. INPLASY REGISTRATION NUMBER: INPLASY2020110066.

Music intervention to relieve anxiety and pain in adults undergoing cardiac surgery: a systematic review and meta-analysis.

OBJECTIVES: Previous studies have reported beneficial effects of perioperative music on patients' anxiety and pain. We performed a systematic review and meta-analysis of randomised controlled trials investigating music interventions in cardiac surgery. METHODS: Five electronic databases were systematically searched. Primary outcomes were patients' postoperative anxiety and pain. Secondary outcomes were hospital length of stay, opioid use, vital parameters and time on mechanical ventilation. PRISMA guidelines were followed and PROSPERO database registration was completed (CRD42020149733). A meta-analysis was performed using random effects models and pooled standardised mean differences (SMD) with 95% confidence intervals were calculated. RESULTS: Twenty studies were included for qualitative analysis (1169 patients) and 16 (987 patients) for meta-analysis. The first postoperative music session was associated with significantly reduced postoperative anxiety (SMD = -0.50 (95% CI -0.67 to -0.32), p<0.01) and pain (SMD = -0.51 (95% CI -0.84 to -0.19), p<0.01). This is equal to a reduction of 4.00 points (95% CI 2.56 to 5.36) and 1.05 points (95% CI 0.67 to 1.41) on the State-Trait Anxiety Inventory and Visual Analogue Scale (VAS)/Numeric Rating Scale (NRS), respectively, for anxiety, and 1.26 points (95% CI 0.47 to 2.07) on the VAS/NRS for pain. Multiple days of music intervention reduced anxiety until 8 days postoperatively (SMD = -0.39 (95% CI -0.64 to -0.15), p<0.01). CONCLUSIONS: Offering recorded music is associated with a significant reduction in postoperative anxiety and pain in cardiac surgery. Unlike pharmacological interventions, music is without side effects so is promising in this population.

Environmental Enrichment in Postoperative Pain and Surgical Care: Potential Synergism With the Enhanced Recovery After Surgery Pathway.

BACKGROUND: Holistic biopsychosocial care has been underemphasized in perioperative pathway designs. The importance and a cost-effective way of implementing biopsychosocial care to improve postoperative pain and facilitate surgical convalescence are not well established, despite the recent popularization of Enhanced Recovery After Surgery (ERAS) programs. OBJECTIVE: We have explored the evidence and rationale of environmental enrichment (EE) as a complementary multimodal psychosocial care pathway to reduce postoperative pain, optimize patient recovery and improve existing weaknesses in surgical care. METHODS: We conducted a database search to identify and grade potential EE techniques for their evidence quality and consistency in the management of acute postoperative pain, perioperative anxiety and the etiologically comparable acute procedural or experimental pain. FINDINGS AND CONCLUSIONS: The introduction of music, virtual reality, educational information, mobile apps, or elements of nature into the healthcare environment can likely improve patients' experience of surgery. Compared with traditional psychological interventions, EE modalities are voluntary, therapist-sparing and more economically sustainable. We have also discussed practical strategies to integrate EE within the perioperative workflow. Through a combination of sensory, motor, social and cognitive modalities, EE is an easily implementable patient-centered approach to alleviate pain and anxiety in surgical patients, create a more homelike recovery environment and improve quality of life.