机械肠道制备与没有肠道制备用于食道癌症手术:一个多中心,随机,并行,开放的标签试验
概括
在食道癌手术中省略机械肠道制备 (MBP) 与使用MBP无差. 这一发现支持在不影响患者安全的情况下简化手术前方案.
科学领域:
- 胃肠病学 胃肠病学
- 手术瘤学手术瘤学
- 临床试验 临床试验
背景情况:
- 机械肠道准备 (MBP) 是胃肠道手术的常见手术前程序.
- 它的必要性和对结果的影响,特别是在食道癌症手术中,需要进一步调查.
研究的目的:
- 在接受食道癌手术的患者中,比较机械肠道制备 (MBP) 与没有MBP (NBP) 的术后影响.
- 为了确定NBP与MBP相比的非劣势.
主要方法:
- 一个多中心,并行,开放的标签试验随机将652名接受食道切除术的患者分为MBP或NBP组.
- 主要结局是手术后30天内出现重大并发症的发生率.
- 二次结果包括克拉维恩-丁多分类 (CCI) 和生活质量评估 (EORTC QLQ-C30和OES-18).
主要成果:
- 在NBP (29.9%) 和MBP (32.5%) 组之间没有观察到重大并发症的显著差异 (风险差异: -2.6%,RR: 0.92).
- 证实了NBP的非劣势性,因为RD和RR的置信区间的上限低于预定义的边际.
- 在CCI中没有发现显著差异;然而,一些生活质量得分 (EORTC QLQ-C30) 在MBP组中显示出改善.
结论:
- 对于接受食道癌手术的患者,没有MBP (NBP) 低于MBP.
- 省略MBP是安全的,并支持简化手术前协议.
- 进一步的研究可能会探索可能从MBP中受益的特定患者子组.
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