简单的口服营养补充剂与胃癌术后患者的常规护理的疗效:多中心,开放标签,并行,随机对照试验的研究方案
Kohei Ueno1, Tatsuto Nishigori2, Yukinari Tokoro1
1Department of Surgery, Kyoto University Hospital, 54 Shogoinkawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan.
Trials
|July 3, 2024
概括
口服营养补充剂 (ONS) 可能有助于预防胃切除术后的体重减轻 (BWL). 这项研究调查了ONS是否能改善胃癌患者手术后的BWL,肌肉力量和生活质量.
科学领域:
- 在瘤学瘤学.
- 胃肠病学 胃肠病学
- 临床营养学 临床营养学
背景情况:
- 胃切除术后体重减轻 (BWL) 是一个严重的问题,影响了患者的治疗结果.
- 口服营养补充剂 (ONS) 建议减轻BWL,但它们对BWL,肌肉力量和HRQoL的疗效的证据仍然不一致.
- 这项研究解决了对特定ONS配方在胃切除术后患者的益处的明确证据的需求.
研究的目的:
- 评估口服营养补充剂 (ONS) 对经过胃切除术的患者减肥的影响.
- 评估ONS对肌肉力量和健康相关生活质量 (HRQoL) 的影响.
- 确定与碳水化合物和蛋白质配制的ONS是否可以改善胃切除术后的粘附性和结果.
主要方法:
- 一个多中心的,开放的,随机对照试验,涉及120名胃癌患者进行胃切除术.
- 患者被随机分配,接受ONS (400千卡/天8周) 或常规护理.
- 主要结局:8周后体重减轻的百分比 (%BWL);次要结局:肌肉强度,HRQoL,营养状况和饮食摄入量.
主要成果:
- 数据分析正在进行中;结果将确定ONS在预防BWL方面的有效性.
- 这项研究将提供关于ONS对肌肉力量和HRQoL的影响的见解.
- 在ONS和对照组之间将比较营养状况和饮食摄入量.
结论:
- 这项试验旨在提供关于ONS在减少BWL和改善胃切除术后HRQoL的有效性的证据.
- 如果结果是积极的,可能会推给胃切除术后的胃癌患者使用含有简单营养的ONS.
- 这些发现可能会影响该群体营养支持的临床指导方针.
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