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21,195 result(s) for "Perioperative"
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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.
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.
Educational video for teaching safe practices in the perioperative period: randomized controlled trial
Objective: to assess the effectiveness of an educational video on hospitalized patients’ knowledge of safe practices in the perioperative period. Method: randomized, double-blind controlled trial carried out in a teaching hospital in the countryside of Minas Gerais. 100 participants undergoing elective orthopaedic surgery were randomly allocated (50 participants in the experimental group and 50 participants in the control group). Patient knowledge was assessed using a questionnaire constructed by the researchers and validated by specialists, before and after the intervention (educational video) or standard guidelines were applied. Descriptive statistics were used for quantitative variables and Student’s t-test for independent samples to analyze the mean difference in knowledge between the experimental and control groups (α = 0.05). Results: 100 participants took part in the study, 50 participants in the experimental group and 50 participants in the control group. The experimental group showed a significantly higher gain in knowledge (t =3.72 ±1.84; p<0.001) than the control group. Cohen’s d was 1.22, indicating a large magnitude of the effect. Conclusion: the educational video was effective in improving patients’ knowledge and can contribute to nurses in the practice of health education, optimizing time and disseminating knowledge about safe practices in the perioperative period. Brazilian Registry of Clinical Trials (REBEC): RBR-8x5mfq. Objetivo: avaliar a efetividade de um vídeo educativo no conhecimento de pacientes hospitalizados acerca das práticas seguras no período perioperatório. Método: ensaio clínico randomizado, duplo-cego, realizado em hospital de ensino no interior de Minas Gerais. Foram alocados aleatoriamente 100 pacientes submetidos à cirurgia ortopédica eletiva (50 no grupo experimental e 50 no controle). O conhecimento do paciente foi avaliado por meio de questionário, construído pelos pesquisadores e validado por especialistas, antes e após a aplicação da intervenção (vídeo educativo) ou orientações-padrão. Adotou-se estatística descritiva para variáveis quantitativas e teste t de Student para amostras independentes na análise da média da diferença do conhecimento entre os grupos experimental e controle (α = 0,05). Resultados: participaram do estudo 100 pacientes, 50 no grupo experimental e 50 no controle. O grupo experimental apresentou ganho de conhecimento significativamente superior ( t =3.72 ±1,84; p <0,001) ao grupo controle. Obteve-se d de Cohen de 1,22, indicando grande magnitude do efeito. Conclusão: o vídeo educativo foi efetivo na melhora do conhecimento dos pacientes e pode contribuir com o enfermeiro, na prática de educação em saúde, na otimização do tempo e na disseminação do conhecimento quanto às práticas seguras no perioperatório. Registro Brasileiro de Ensaios Clínicos (REBEC): RBR-8x5mfq. Objetivo: evaluar la efectividad de un video educativo en el conocimiento de pacientes hospitalizados sobre las prácticas seguras en el período perioperatorio. Método: ensayo clínico aleatorizado, doble ciego, realizado en un hospital docente en el interior de Minas Gerais. Se asignaron aleatoriamente 100 pacientes sometidos a cirugía ortopédica electiva (50 en el grupo experimental y 50 en el control). El conocimiento del paciente se evaluó mediante un cuestionario, construido por los investigadores y validado por especialistas, antes y después de la aplicación de la intervención (video educativo) o instrucciones estándar. Se adoptó estadística descriptiva para variables cuantitativas y prueba t de Student para muestras independientes en el análisis de la media de la diferencia de conocimiento entre los grupos experimental y control (α = 0,05). Resultados: participaron en el estudio 100 pacientes, 50 en el grupo experimental y 50 en el control. El grupo experimental mostró una ganancia de conocimiento significativamente superior ( t =3.72 ±1,84; p <0,001) al grupo control. Se obtuvo un d de Cohen de 1,22, indicando una gran magnitud del efecto. Conclusión: el video educativo fue efectivo en mejorar el conocimiento de los pacientes y puede contribuir con el enfermero, en la práctica de educación en salud, en la optimización del tiempo y en la difusión del conocimiento sobre las prácticas seguras en el perioperatorio. Registro Brasileño de Ensayos Clínicos (REBEC): RBR-8x5mfq.
Does Mandala Art Therapy Improve Psychological Well-Being of Gynecological Cancer Patients During the Perioperative Period? A Quasi-Experimental Study
Background: Women with gynecological cancer often experience psychological distress, particularly in response to surgical procedures. The impact of mandala art therapy (MAT) during the perioperative period for gynecological cancer patients remains uncertain. We aimed to examine the effects of the MAT program in women with gynecological cancer. Methods: Employing a quasi-experimental design, we recruited 126 gynecological cancer patients from a university hospital through convenience sampling. Participants were assigned to either receive the MAT program or standard perioperative care. The interventions comprised a three-session MAT program guided by a team of trained mandala psychologists. Generalized estimating equations (GEE) were employed to analyze the effects of MAT over time. Results: A total of 126 patients were enrolled, and 118 completed the entire study. Over 90% of participants completed the perioperative MAT interventions, reporting relatively high satisfaction with the program (7.70 out of 10). Individuals in the MAT group exhibited improved therapeutic effects on STAI-S, VASS, and vital signs over time. Notably, significant group*time interaction effects were noted in STAI-S scores at both the first evaluation, T1 (β = −4.220, P < .005) and the third evaluation, T3 (β = −3.797, P < .05), and VASS scores at T1 (β = −11.186, P < .005), T2 (β = −9.915, P < .05) and T3 (β = −9.831, P < .05). Regarding vital signs, the multivariate GEE model revealed significant interaction effects in systolic blood pressure values at both T1 (β = −7.102, P < .05) and T3 (β = −10.051, P < .005), diastolic blood pressure values at T3 (β = −6.441, P < .005), and pulse values at T1 (β = −6.085, P < .005). No significant differences were observed between groups for pain, hope, or self-acceptance. Conclusion: This study posited that MAT could serve as a valuable complementary approach in perioperative care for addressing the psychological needs of women with gynecological cancer. Subsequent research employing more robust methodologies and larger, more diverse participant samples will be necessary to validate these conclusions.
Clinical Issues — November 2024
THIS MONTHReducing the perioperative carbon footprintKey words: sustainability, carbon footprint, greenhouse gas (GHG), energy, consumption. Exsanguination before tourniquet useKey words: elastic wrap, exsanguination, gravity, pneumatic tourniquet, limb. Using augmented reality technology in the ORKey words: augmented reality (AR), virtual reality (VR), extended reality (XR), headset, navigation. Patients wearing contact lenses during a procedureKey words: contact lens, corneal abrasion, patient positioning, eye injury, risk factors.
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.