K-LARS试验:多中心随机对照试验的协议,评估知识增强的数字干预措施,以预防韩国低前切除综合征
Seung-Bum Ryoo1,2, Hong-Min Ahn3, Byung-Ho Nam4
1Surgery, Seoul National University College of Medicine, Seoul, Jongno-gu, Korea (the Republic of).
BMJ open
|November 30, 2025
概括
移动数字干预可以减少直肠癌手术后的主要低前切除综合征 (LARS). 这项研究评估了其对患者生活质量和LARS发病率的影响.
科学领域:
- 胃肠病学 胃肠病学
- 在瘤学瘤学.
- 数字健康数字健康
背景情况:
- 低前切除综合征 (LARS) 是直肠癌手术后的常见并发症,影响患者的生活质量.
- 目前对LARS的管理策略往往是不够的,强调需要有效的预防措施.
研究的目的:
- 评估基于移动,知识增强的数字干预在减少主要LARS的发生率方面的有效性.
- 评估干预对生活质量和其他患者报告的结果的影响.
主要方法:
- 一个多中心的,开放标签的,随机对照试验,涉及300名患者,接受了低前切除或直肠癌的口腔逆转.
- 参与者被随机分配1:1接受移动数字程序或标准教育材料.
- 主要结局是手术后12个月重大LARS发病率 (得分≥30),次要结局包括生活质量测量.
主要成果:
- 该研究正在进行中,结果正在等待.
- 主要结果是12个月大LARS的发生率.
- 二次结果包括LARS得分,生活质量 (EORTC QLQ-C30,CR29),EQ-5D-5L,患者满意度和坚持.
结论:
- 该研究将提供关于数字干预措施对LARS预防有效性的关键数据.
- 研究结果将为直肠癌患者的术后护理策略提供信息.
- 传播将通过同行评审的出版物和会议演讲进行.
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