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13,815 result(s) for "Perioperative care"
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Perioperative Chemotherapy or Preoperative Chemoradiotherapy in Esophageal Cancer
The best multimodal approach for resectable locally advanced esophageal adenocarcinoma is unclear. An important question is whether perioperative chemotherapy is preferable to preoperative chemoradiotherapy. In this phase 3, multicenter, randomized trial, we assigned in a 1:1 ratio patients with resectable esophageal adenocarcinoma to receive perioperative chemotherapy with FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) plus surgery or preoperative chemoradiotherapy (radiotherapy at a dose of 41.4 Gy and carboplatin and paclitaxel) plus surgery. Eligibility criteria included a primary tumor with a clinical stage of cT1 cN+, cT2-4a cN+, or cT2-4a cN0 disease, in which T indicates the size and extent of the tumor (higher numbers indicate a more advanced tumor), and N indicates the presence (N+) or absence (N0) of cancer spread to the lymph nodes, without evidence of metastatic spread. The primary end point was overall survival. From February 2016 through April 2020, we assigned 221 patients to the FLOT group and 217 patients to the preoperative-chemoradiotherapy group. With a median follow-up of 55 months, overall survival at 3 years was 57.4% (95% confidence interval [CI], 50.1 to 64.0) in the FLOT group and 50.7% (95% CI, 43.5 to 57.5) in the preoperative-chemoradiotherapy group (hazard ratio for death, 0.70; 95% CI, 0.53 to 0.92; P = 0.01). Progression-free survival at 3 years was 51.6% (95% CI, 44.3 to 58.4) in the FLOT group and 35.0% (95% CI, 28.4 to 41.7) in the preoperative-chemoradiotherapy group (hazard ratio for disease progression or death, 0.66; 95% CI, 0.51 to 0.85). Among the patients who started the assigned treatment, grade 3 or higher adverse events were observed in 120 of 207 patients (58.0%) in the FLOT group and in 98 of 196 patients (50.0%) in the preoperative-chemoradiotherapy group. Serious adverse events were observed in 98 of 207 patients (47.3%) in the FLOT group and in 82 of 196 patients (41.8%) in the preoperative-chemoradiotherapy group. Mortality at 90 days after surgery was 3.1% in the FLOT group and 5.6% in the preoperative-chemoradiotherapy group. Perioperative chemotherapy with FLOT led to improved survival among patients with resectable esophageal adenocarcinoma as compared with preoperative chemoradiotherapy. (Funded by the German Research Foundation; ESOPEC ClinicalTrials.gov number, NCT02509286.).
Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer
In resectable gastric and gastroesophageal junction cancer, adding durvalumab to perioperative chemotherapy improved event-free survival and pathological complete response, with no major increase in high-grade adverse events.
Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations—2019 update
This is the first updated Enhanced Recovery After Surgery (ERAS) Society guideline presenting a consensus for optimal perioperative care in gynecologic/oncology surgery. A database search of publications using Embase and PubMed was performed. Studies on each item within the ERAS gynecologic/oncology protocol were selected with emphasis on meta-analyses, randomized controlled trials, and large prospective cohort studies. These studies were then reviewed and graded according to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system. All recommendations on ERAS protocol items are based on best available evidence. The level of evidence for each item is presented accordingly. The updated evidence base and recommendation for items within the ERAS gynecologic/oncology perioperative care pathway are presented by the ERAS® Society in this consensus review.
Stress Reduction in Perioperative Care: Feasibility Randomized Controlled Trial
Patients undergoing surgery often experience stress and anxiety, which can increase complications and hinder recovery. Effective management of these psychological factors is key to improving outcomes. Preoperative anxiety is inversely correlated with the amount of information patients receive, but accessible, personalized support remains limited, especially in preoperative settings. Face-to-face education is often impractical due to resource constraints. Digital health (DH) interventions offer a promising alternative, enhancing patient engagement and empowerment. However, most current tools focus on providing information, overlooking the importance of personalization and psychological support. This study aimed to assess the viability of a DH intervention known as the Adhera CARINAE DH Program. This program is specifically designed to offer evidence-based and personalized stress- and anxiety-management techniques. It achieves this by using a comprehensive digital ecosystem that incorporates wearable devices, mobile apps, and virtual reality technologies. The intervention program also makes use of advanced data-driven techniques to deliver tailored patient education and lifestyle support. A total of 74 patients scheduled for surgery across 4 hospitals in 3 European countries were enrolled in this study from September 2021 to March 2022. Surgeries included cardiopulmonary and coronary artery bypass surgeries, cardiac valve replacements, prostate or bladder cancer surgeries, hip and knee replacements, maxillofacial surgery, and scoliosis procedures. After assessment for eligibility, participants were randomized into 2 groups: the intervention group (n=23) received the Adhera CARINAE DH intervention in addition to standard care, while the control group (n=27) received standard care alone. Psychological metrics such as self-efficacy, self-management, and mental well-being were assessed before and after the intervention, alongside physiological markers of stress. The intervention group demonstrated significant improvements across several psychological outcomes. For example, Visual Analogue Scale Stress at the hospital improved at admission by 5% and at hospital discharge by 11.1% and Visual Analogue Scale Pain at admission improved by 31.2%. In addition, Hospital Anxiety and Depression Scale Anxiety after surgery improved by 15.6%, and Positive and Negative Affect Scale-Negative at hospital admission improved by 17.5%. Overall, patients in the intervention study spent 17.12% less days in the hospital. Besides these individual scores, the intervention group shows more positive relationships among the psychological dimensions of self-efficacy, self-management, and mental well-being, suggesting that the CARINAE solution could have a positive effect and impact on the reduction of stress and negative emotions. Our results provide an important first step toward a deeper understanding of optimizing DH solutions to support patients undergoing surgery and for potential applications in remote patient monitoring and communication. ClinicalTrials.gov NCT05184725; https://clinicaltrials.gov/study/NCT05184725. RR2-10.2196/38536.
Enhanced Recovery After Surgery (ERAS) Program Attenuates Stress and Accelerates Recovery in Patients After Radical Resection for Colorectal Cancer: A Prospective Randomized Controlled Trial
Background The aim of this trial was to compare the Enhanced Recovery After Surgery (ERAS) program with conventional perioperative management in patients who underwent radical resection for colorectal cancer. Methods A combination of evidence-based and consensus methodology was used to develop the ERAS protocol. Five hundred ninety-seven consecutive patients who underwent elective colorectal resection were randomized to either the ERAS ( n  = 299) or the control group ( n  = 298). Outcomes relating to nutrition and metabolism index, stress index, and recovery index were measured and recorded. Results Demographic and operative data were similar between the two groups. Patients in the ERAS group showed improved nutritional status when compared with those of the control group. On postoperative day (POD) 1, the HOMA-IR (insulin resistance index) of the ERAS group was lower than that of the control group ( p  < 0.001). The cortisol level of the control group was elevated on both POD 1 ( p  = 0.007) and POD 5 ( p  = 0.002) compared to the preoperative level. However, the cortisol level of the ERAS group was not increased until POD 5 ( p  = 0.001). Reduced levels of TNF-α, IL-1β, IL-6, and IFN-γ in the ERAS group indicated less postoperative stress responses. In addition, ERAS was associated with accelerated recovery of gastrointestinal function. The postoperative length of stay ( p  < 0.001) and expense ( p  < 0.001) for the ERAS group were reduced in comparison to the controls. Twenty-eight cases in the control group and twenty-nine in the ERAS group suffered complications, which was not significantly different. Conclusion The ERAS protocol attenuates the surgical stress response and accelerates postoperative recovery without compromising patient safety.
Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations: A 2021 Update
Background This is the second updated Enhanced Recovery After Surgery (ERAS®) Society guideline, presenting a consensus for optimal perioperative care in bariatric surgery and providing recommendations for each ERAS item within the ERAS® protocol. Methods A principal literature search was performed utilizing the Pubmed, EMBASE, Cochrane databases and ClinicalTrials.gov through December 2020, with particular attention paid to meta-analyses, randomized controlled trials and large prospective cohort studies. Selected studies were examined, reviewed and graded according to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system. After critical appraisal of these studies, the group of authors reached consensus regarding recommendations. Results The quality of evidence for many ERAS interventions remains relatively low in a bariatric setting and evidence-based practices may need to be extrapolated from other surgeries. Conclusion A comprehensive, updated evidence-based consensus was reached and is presented in this review by the ERAS® Society.
Assessment of the adherence to perioperative nutritional care protocols in Brazilian hospitals: The PreopWeek study
•Only 12.5% of participant hospitals have institutional perioperative protocols.•Most of the patients received general and nutritional preoperative counseling.•One-quarter of the patients had preoperative fasting longer than 3 h.•Immunonutrition was not received by 43.8% at any point during the perioperative period.•Even hospitals with institutional protocols lacked adherence to some items. The study (PreopWeek) aimed to assess the perioperative nutritional care for major surgical patients in Brazilian hospitals, focusing on adherence to emerging multimodal protocols like Enhanced Recovery After Surgery and Acceleration of Total Postoperative Recovery. An observational cross-sectional study was conducted in Brazilian hospitals enrolled voluntarily from June 19 to June 23, 2023 (convenience sample). Data were collected through patient interviews and medical records review. Data from 219 patients up to the fifth postoperative day or postoperative discharge across 24 hospitals were analyzed. Only three hospitals (12.5%) had established institutional perioperative protocols. Most of the patients were female (60.3%) and over 60 y old (81.7%) and underwent gastrointestinal (34.7%) or orthopedic (33.3%) surgeries. General and nutritional preoperative counseling was provided to a respective 82.2% and 62.6% of the patients. Only 25.7% of the patients had preoperative fasting for up to 3 h, and 28.8% received carbohydrate-rich supplements. Immunonutrition was not received by 43.8% at any point. Although most started postoperative refeeding within 24 h (81.7%), 39.4% started with a liquid diet and 70.6% reported postoperative immobilization in the first 24 h. Notable differences were observed between hospitals with and without protocols. Hospitals with institutional protocols reported significantly more preoperative exercises and nutritional counseling and higher adherence rates for all the perioperative protocols. Our study demonstrates a lack of adherence to the multimodal protocols, even in hospitals with institutional protocols. Future educational programs are necessary to improve this result.
Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial
Surgical resection alone is regarded as the standard of care for patients with liver metastases from colorectal cancer, but relapse is common. We assessed the combination of perioperative chemotherapy and surgery compared with surgery alone for patients with initially resectable liver metastases from colorectal cancer. This parallel-group study reports the trial's final data for progression-free survival for a protocol unspecified interim time-point, while overall survival is still being monitored. 364 patients with histologically proven colorectal cancer and up to four liver metastases were randomly assigned to either six cycles of FOLFOX4 before and six cycles after surgery or to surgery alone (182 in perioperative chemotherapy group vs 182 in surgery group). Patients were centrally randomised by minimisation, adjusting for centre and risk score. The primary objective was to detect a hazard ratio (HR) of 0·71 or less for progression-free survival. Primary analysis was by intention to treat. Analyses were repeated for all eligible (171 vs 171) and resected patients (151 vs 152). This trial is registered with ClinicalTrials.gov, number NCT00006479. In the perioperative chemotherapy group, 151 (83%) patients were resected after a median of six (range 1–6) preoperative cycles and 115 (63%) patients received a median six (1–8) postoperative cycles. 152 (84%) patients were resected in the surgery group. The absolute increase in rate of progression-free survival at 3 years was 7·3% (from 28·1% [95·66% CI 21·3–35·5] to 35·4% [28·1–42·7]; HR 0·79 [0·62–1·02]; p=0·058) in randomised patients; 8·1% (from 28·1% [21·2–36·6] to 36·2% [28·7–43·8]; HR 0·77 [0·60–1·00]; p=0·041) in eligible patients; and 9·2% (from 33·2% [25·3–41·2] to 42·4% [34·0–50·5]; HR 0·73 [0·55–0·97]; p=0·025) in patients undergoing resection. 139 patients died (64 in perioperative chemotherapy group vs 75 in surgery group). Reversible postoperative complications occurred more often after chemotherapy than after surgery (40/159 [25%] vs 27/170 [16%]; p=0·04). After surgery we recorded two deaths in the surgery alone group and one in the perioperative chemotherapy group. Perioperative chemotherapy with FOLFOX4 is compatible with major liver surgery and reduces the risk of events of progression-free survival in eligible and resected patients. Swedish Cancer Society, Cancer Research UK, Ligue Nationale Contre le Cancer, US National Cancer Institute, Sanofi-Aventis.
Adapted ERAS Pathway vs. Standard Care in Patients with Perforated Duodenal Ulcer—a Randomized Controlled Trial
Objectives The objective of this study was to evaluate the feasibility and efficacy of ERAS pathways in patients undergoing emergency simple closure of perforated duodenal ulcer (PDU). Methods This single-center, prospective, open-labeled, superiority, RCT was carried out from August 2014 to July 2016. Patients of PDU undergoing open simple closure were randomized preoperatively in 1:1 ratio into standard care and adapted ERAS group. Patients with refractory shock, ASA class ≥3, and perforation size ≥1 cm were excluded. Primary outcome was the length of hospitalization (LOH). Secondary outcomes were functional recovery parameters and morbidity. Results Forty-nine and 50 patients were included in standard care and ERAS group, respectively. Patients in ERAS group had a significantly early functional recovery (days) for the time to first flatus (1.47 ± 0.18; p  < 0.001), first stool (2.25 ± 0.20; p  < 0.001), first fluid diet (2.72 ± 0.38; p  < 0.001), and solid diet (3.70 ± 0.44; p  < 0.001). LOH in ERAS group was significantly shorter (mean difference of 4.41 ± 0.64 days; p  < 0.001). There was a significant reduction in postoperative morbidity such as superficial SSI (RR 0.35, p  = 0.02), postoperative nausea and vomiting (RR 0.28, p  < 0.0001), and pulmonary complications (RR 0.24, p  = 0.04) in the ERAS vs. standard care group with similar leak rates (1/50 vs.2/49). Conclusion ERAS pathways are safe and feasible in select patients undergoing emergency simple closure of PDU.
EAES/SAGES evidence-based recommendations and expert consensus on optimization of perioperative care in older adults
BackgroundAs the population ages, more older adults are presenting for surgery. Age-related declines in physiological reserve and functional capacity can result in frailty and poor outcomes after surgery. Hence, optimizing perioperative care in older patients is imperative. Enhanced Recovery After Surgery (ERAS) pathways and Minimally Invasive Surgery (MIS) may influence surgical outcomes, but current use and impact on older adults patients is unknown. The aim of this study was to provide evidence-based recommendations on perioperative care of older adults undergoing major abdominal surgery.MethodsExpert consensus determined working definitions for key terms and metrics related to perioperative care. A systematic literature review and meta-analysis was performed using the PubMed, Embase, Cochrane Library, and Clinicaltrials.gov databases for 24 pre-defined key questions in the topic areas of prehabilitation, MIS, and ERAS in major abdominal surgery (colorectal, upper gastrointestinal (UGI), Hernia, and hepatopancreatic biliary (HPB)) to generate evidence-based recommendations following the GRADE methodology.ResultOlder adults were defined as 65 years and older. Over 20,000 articles were initially retrieved from search parameters. Evidence synthesis was performed across the three topic areas from 172 studies, with meta-analyses conducted for MIS and ERAS topics. The use of MIS and ERAS was recommended for older adult patients particularly when undergoing colorectal surgery. Expert opinion recommended prehabilitation, cessation of smoking and alcohol, and correction of anemia in all colorectal, UGI, Hernia, and HPB procedures in older adults. All recommendations were conditional, with low to very low certainty of evidence, with the exception of ERAS program in colorectal surgery.ConclusionsMIS and ERAS are recommended in older adults undergoing major abdominal surgery, with evidence supporting use in colorectal surgery. Though expert opinion supported prehabilitation, there is insufficient evidence supporting use. This work has identified evidence gaps for further studies to optimize older adults undergoing major abdominal surgery.