Ho ChiouYi, Daud Zulfitri Azuan Mat, Mohd Yusof Barakatun Nisak, Abdul Majid Hazreen
Department of Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia.
Department of Dietetics and Food Service, Institut Kanser Negara, Ministry of Health Malaysia, Wilayah Persekutuan Putrajaya, Malaysia.
PLoS One. 2024 Dec 31;19(12):e0315568. doi: 10.1371/journal.pone.0315568. eCollection 2024.
BACKGROUND & AIMS: Enhanced Recovery After Surgery (ERAS) has shown significant improvements in postoperative outcomes and a reduction in complications, while immunonutrition (IMN) has been shown to modulate the immune system and inflammatory response. However, many studies have overlooked the crucial aspects of nutrition status and patient perception within the intervention approach. This study aims to investigate the efficacy and explore patients' acceptance of the IMN intervention in postoperative outcomes among gynecological cancer (GC) patients under the ERAS framework.
This two-phase explanatory sequential mixed-method study design comprises an open-labeled randomized control trial and a qualitative study. The GC participants will be randomly allocated into intervention and control groups. Malaysian adults scheduled for elective surgery will be recruited, with the intervention group receiving IMN for five days before and seven days after elective surgery, while the control group undergoes routine nutritional care before the operation. Both groups will adhere to the ERAS protocol. An explanatory qualitative study will be conducted among GC patients to elucidate their expectations following the trial. Study outcomes include hospitalization duration, change in nutrition status, biochemical profile, functional status, and quality of life. Additionally, the secondary outcome focuses on evaluating the perception of the intervention approach. Quantitative and qualitative data will be analyzed on an intention-to-treat basis and through inductive thematic analysis, respectively.
Implementing perioperative IMN intervention within the ERAS framework may contribute to the preservation of better nutrition status and the provision of sufficient dietary intake to support postoperative recovery, and promote better surgical outcomes. Patients' perceptions play a pivotal role in enhancing understanding of disease management and adherence to the intervention approach.
NCT06039306.
术后加速康复（ERAS）已显示出术后结局有显著改善且并发症减少，而免疫营养（IMN）已被证明可调节免疫系统和炎症反应。然而，许多研究在干预方法中忽略了营养状况和患者认知的关键方面。本研究旨在探讨在ERAS框架下免疫营养干预对妇科癌症（GC）患者术后结局的疗效，并探索患者对该干预的接受度。
这项两阶段的解释性序贯混合方法研究设计包括一项开放标签随机对照试验和一项定性研究。GC参与者将被随机分配到干预组和对照组。将招募计划进行择期手术的马来西亚成年人，干预组在择期手术前5天和术后7天接受IMN，而对照组在手术前接受常规营养护理。两组都将遵循ERAS方案。将对GC患者进行一项解释性定性研究，以阐明他们在试验后的期望。研究结局包括住院时间、营养状况变化、生化指标、功能状态和生活质量。此外，次要结局侧重于评估对干预方法的认知。定量和定性数据将分别基于意向性分析和通过归纳主题分析进行分析。
在ERAS框架内实施围手术期IMN干预可能有助于保持更好的营养状况，提供足够的饮食摄入以支持术后恢复，并促进更好的手术结局。患者的认知在增强对疾病管理的理解和对干预方法的依从性方面起着关键作用。
NCT06039306。
